Publications by authors named "Prakesh S Shah"

346 Publications

Variability in antimicrobial use among infants born at <33 weeks gestational age.

Infect Control Hosp Epidemiol 2021 Sep 17:1-5. Epub 2021 Sep 17.

Maternal-infant Care Research Centre, Mount Sinai Hospital, Toronto, Ontario, Canada.

Excessive antimicrobial use is associated with adverse neonatal outcomes. In our cohort of 27,163 infants born at <33 weeks gestational age, the first week after birth accounted for the highest rates of antimicrobial use, and variability across sites persisted after adjustment for patient characteristics correlated with illness severity.
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http://dx.doi.org/10.1017/ice.2021.380DOI Listing
September 2021

SARS-CoV-2 Exposure from Health Care Workers to Infants: Effects and Outcomes.

Am J Perinatol 2021 Aug 27. Epub 2021 Aug 27.

Department of Pediatrics, Mount Sinai Hospital, Toronto, Ontario, Canada.

Objective:  This study aimed to evaluate the risk and outcomes of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission from positive health care workers (HCW) to infants in the neonatal intensive care unit (NICU) and the postnatal ward.

Study Design:  We conducted a retrospective analysis of infants in NICU and the postnatal ward postexposure to a COVID-19 positive HCW between May 1 and July 31, 2020. HCW had the detection of SARS-CoV-2 after being symptomatic. Infants exposed to these HCW were tested for SARS-CoV-2 and were classified as confirmed positive when test was positive 24 hours after exposure; confirmed negative when test was negative with no escalation of respiratory support provided; and probable if test was negative. However, infant required escalation of respiratory support. Infants were followed at 14 days postexposure then at the end of the study period for admitted infants.

Results:  A total of 31 infants were exposed to SARS-CoV-2 positive HCWs (42 exposure incidences). The median age at exposure was 21 days. None of the infants was confirmed positive. Nine infants were classified as probable cases of whom five infants with underlying chronic illnesses died, two were discharged home, and two were still admitted. Of the 22 confirmed negative cases, 15 were discharged and were well on follow-up, and 7 were still admitted.

Conclusion:  No active transmission of infection from infected HCW to admitted infants was identified. Although some infants had respiratory escalation postexposure none were confirmed positive. Adhering to personal protective equipment by HCW or low susceptibility of infants to SARS-CoV-2 infection may explain the lack of transmission.

Key Points: · There are no reported cases of transmission of SARS-CoV-2 infection from infected HCW to infants admitted to the NICU in our study.. · Adherence to personnel protective equipment is important to prevent transmission of SARS-CoV-2. · When an infant is exposed to a HCW who is positive for SARS-CoV-2 and has escalation of respiratory support, SARS-CoV-2 as a cause should be investigated.
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http://dx.doi.org/10.1055/s-0041-1735215DOI Listing
August 2021

Delayed cord clamping in small for gestational age preterm infants.

Am J Obstet Gynecol 2021 Aug 9. Epub 2021 Aug 9.

Division of Neonatal-Perinatal Medicine, Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.

Background: Infants with restricted growth for age are frequently exposed to insufficient placental circulation and are more likely to develop postnatal complications. Delayed cord clamping at birth for these infants requires further exploration.

Objective: This study aimed to compare the short-term neonatal outcomes of delayed cord clamping with that of early cord clamping in small for gestational age preterm infants and to explore whether the effects of delayed cord clamping in small for gestational age preterm infants are different from that in non-small for gestational age preterm infants.

Study Design: We conducted a national retrospective cohort study, including infants born at <33 weeks' gestation and admitted to the Canadian Neonatal Network units between January 2015 and December 2017. Small for gestational age infants (birthweight of <10th percentile for gestational age and sex) who received delayed cord clamping ≥30 seconds were compared with those who received early cord clamping. In addition, non-small for gestational age infants who received delayed cord clamping were compared with those who received early cord clamping. The main study outcomes included composite outcome of mortality or major morbidity, neonatal morbidity rate, mortality rate, peak serum bilirubin, and number of blood transfusions. Multivariable logistic and linear regression models with a generalized estimation equation approach were used to account for the clustering of infants within centers.

Results: Overall, 9722 infants met the inclusion criteria. Of those infants, 1027 (10.6%) were small for gestational age. The median (interquartile range) gestational age was 31 weeks (range, 28-32 weeks). After adjusting for potential confounders, delayed cord clamping in small for gestational age infants was associated with a reduction in the composite outcome of mortality or major morbidity (adjusted odds ratio, 0.60; 95% confidence interval, 0.42-0.86) compared with early cord clamping. There was no difference between the 2 groups in peak serum bilirubin. Many associated benefits of delayed cord clamping in small for gestational age infants were similar to those in non-small for gestational age infants.

Conclusion: Delayed cord clamping in small for gestational age preterm infants was associated with decreased odds of mortality or major morbidity. Many of the benefits of delayed cord clamping in the small for gestational age preterm infants were similar to those identified in the non-small for gestational age preterm infants.
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http://dx.doi.org/10.1016/j.ajog.2021.08.003DOI Listing
August 2021

Preterm birth and stillbirth rates during the COVID-19 pandemic: a population-based cohort study.

CMAJ 2021 08;193(30):E1164-E1172

Department of Pediatrics and Maternal-Infant Care Research Centre (Shah, Ye, Yang), Mount Sinai Hospital; Department of Pediatrics (Shah), University of Toronto; ICES (Campitelli), Toronto, Ont.

Background: Conflicting reports have emerged for rates of preterm births and stillbirths during the COVID-19 pandemic. Most of these reports did not account for natural variation in these rates. We aimed to evaluate variations in preterm birth and stillbirth rates before and during the COVID-19 pandemic in Ontario, Canada.

Methods: We conducted a retrospective cohort study using linked population health administrative databases of pregnant people giving birth in any hospital in Ontario between July 2002 and December 2020. We calculated preterm birth and stillbirth rates. We assessed preterm birth at 22-28, 29-32 and 33-36 weeks' gestation, and stillbirths at term and preterm gestation. We used Laney control P' charts for the 18-year study period (6-mo observation periods) and interrupted time-series analyses for monthly rates for the most recent 4 years.

Results: We evaluated 2 465 387 pregnancies, including 13 781 that resulted in stillbirth. The mean preterm birth rate for our cohort was 7.96% (range 7.32%-8.59%). From January to December 2020, we determined that the preterm birth rate in Ontario was 7.87%, with no special cause variation. The mean stillbirth rate for the cohort was 0.56% (range 0.48%-0.70%). From January to December 2020, the stillbirth rate was 0.53%, with no special cause variation. We did not find any special cause variation for preterm birth or stillbirth subgroups. We found no changes in slope or gap between prepandemic and pandemic periods using interrupted time-series analyses.

Interpretation: In Ontario, Canada, we found no special cause variation (unusual change) in preterm birth or stillbirth rates, overall or by subgroups, during the first 12 months of the COVID-19 pandemic compared with the previous 17.5 years.
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http://dx.doi.org/10.1503/cmaj.210081DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8354648PMC
August 2021

Long-Term Outcomes of Pediatric Living versus Deceased Donor Liver Transplant Recipients: A Systematic Review and Meta-analysis.

Liver Transpl 2021 Jul 31. Epub 2021 Jul 31.

Institute for Health Policy, Management and Evaluation, University of Toronto.

Background: Living donor liver transplantation (LDLT) emerged in the 1980s as a viable alternative to scarce cadaveric organs for pediatric patients. However, pediatric waitlist mortality remains high. Long-term outcomes of living and deceased liver transplantation (DDLT) are inconsistently described in the literature. Our aim was to systematically review the safety and efficacy of LDLT after one year of transplantation among pediatric patients with all causes of liver failure.

Methods: We searched the MEDLINE, Embase, and Classic+Embase databases from 1947 to February 26, 2020, without language restrictions. The primary outcomes were patient and graft survival beyond one year post-transplantation. A meta-analysis of unadjusted/adjusted odds and hazard ratios was performed using a random-effects model.

Results: A total of 24 studies with 3677 patients who underwent LDLT and 9098 patients who underwent DDLT were included for analysis. In patients with chronic or combined chronic/acute liver failure, 1- (OR 0.68; 95% CI [0.53-0.88]), 3- (OR 0.73; 95% CI [0.61-0.89]), 5- (OR 0.71; 95% CI [0.57-0.89]) and 10-year (OR 0.42; 95% CI [0.18-1.00]) patient and 1- (OR 0.50; 95% CI [0.35-0.70]), 3- (OR 0.55; 95% CI [0.37-0.83]), 5- (OR 0.5; 95% CI [0.32-0.76]) and 10-year (OR 0.26; 95% CI [0.14-0.49]) graft survival was consistently better in LDLT recipients compared to DDLT recipients. In patients with acute liver failure, no difference was seen between the two groups except for 5-year patient survival (OR 0.60; 95% CI [0.38-0.95]), which favored LDLT. Sensitivity analysis by era showed improved survival in the most recent cohort of patients, consistent with the well-described learning curve for the LDLT technique.

Conclusion: LDLT provides superior patient and graft survival outcomes relative to DDLT in pediatric patients with chronic and acute liver failure. More resources may be needed to develop infrastructures and healthcare systems to support living liver donation.
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http://dx.doi.org/10.1002/lt.26250DOI Listing
July 2021

COVID-19 Disease in Infants Less Than 90 Days: Case Series.

Front Pediatr 2021 12;9:674899. Epub 2021 Jul 12.

Department of Pediatrics, Mount Sinai Hospital, Toronto, ON, Canada.

The objective of this study is to describe the clinical presentations, radiological and laboratory findings, and outcomes of COVID-19 disease in infants ≤ 90 days of age at presentation. We conducted a retrospective study of infants in this age group who were found to be SARS-CoV-2 positive. Asymptomatic infants who were identified through routine testing following delivery to COVID-19-positive mothers were excluded. We classified infants according to their presentation: asymptomatic, mildly symptomatic, moderately symptomatic, and severely/critically symptomatic. A total of 36 infants were included. Of them, two were asymptomatic and four had severe/critical presentation. Of the severely symptomatic infants, two were considered as multisystem inflammatory syndrome in children (MIS-C) and there was one death. One infant in the severe symptomatic group presented with cardiac failure, with the possibility of congenital infection. Another infant presented with cardiogenic shock. None of these infants received antiviral medication. The study found that infants ≤ 90 days can present with a severe form of COVID-19 disease. Multisystem inflammatory syndrome in children, although rarely reported in infants, is a possible complication of COVID-19 disease and can be associated with significant morbidity and mortality.
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http://dx.doi.org/10.3389/fped.2021.674899DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8311174PMC
July 2021

Lung Ultrasound for Prediction of Bronchopulmonary Dysplasia in Extreme Preterm Neonates: A Prospective Diagnostic Cohort Study.

J Pediatr 2021 Jul 6. Epub 2021 Jul 6.

Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada; Department of Pediatrics, Mount Sinai Hospital, Toronto, Ontario, Canada.

Objectives: To evaluate the diagnostic and predictive ability of lung ultrasound at 3 time points in the first 2 weeks after birth for predicting bronchopulmonary dysplasia (BPD) among infants <29 weeks of gestational age.

Study Design: This was a prospective, diagnostic cohort study. Lung ultrasound was performed on days 3, 7, and 14 after birth and lung ultrasound scores (LUS) were calculated in blinded fashion. Diagnostic test characteristics and area under receiver operating characteristic (AUROC) curves were calculated.

Results: A total of 152 infants were enrolled with mean (SD) gestational age of 25.8 (1.5) weeks gestation. Of them, 87 (57%) infants were diagnosed with BPD. The LUS were significantly higher in infants diagnosed with BPD compared with those without BPD at all scan time points (P < .01). The score of >10 at all 3 time points had higher sensitivity (0.89, 0.89, and 0.77), specificity (0.87, 0.90, and 0.92), and corresponding clinically important positive and negative likelihood ratios. The AUROC for LUS at the 3 time points were 0.96, 0.97, and 0.95 on day 3, 7, and 14, respectively. Compared with the model using clinical characteristics, LUS alone had higher AUROC (P < .05 for all 3 time points).

Conclusions: In this cohort, LUS in the first 2 weeks after birth had a very high predictive value for the diagnosis of BPD among infants of <29 weeks of gestation.

Trial Registration: ClinicalTrials.govNCT04756297.
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http://dx.doi.org/10.1016/j.jpeds.2021.06.079DOI Listing
July 2021

Bloodstream Infections in Preterm Neonates and Mortality-Associated Risk Factors.

J Pediatr 2021 Jun 22. Epub 2021 Jun 22.

Department of pediatrics, University of Toronto, Toronto, Ontario, Canada; Department of pediatrics, Mount Sinai Hospital, Toronto, Ontario, Canada; Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada; Department of Physiology, University of Toronto, Toronto, Ontario, Canada. Electronic address:

Objective: To investigate the association of early (±4 hours after onset of bloodstream infection) clinical and laboratory variables with episode-related mortality (<7 days).

Study Design: This 2-site retrospective study included 142 neonates born at <35 weeks of gestational age with positive blood/cerebrospinal fluid (CSF) culture at >72 hours of age from organisms other than coagulase-negative Staphylococcus. Early variables were compared between those with bloodstream infection-related mortality and survivors. Multivariable analysis was conducted for the primary outcome, and the area under the curve (AUC) was estimated for relevant variables.

Results: The neonates who died were of lower gestational age at disease onset. After adjusting for relevant variables, lowest mean blood pressure (MBP) (aOR, 0.10; 95% CI, 1.02-1.19) and highest base deficit (aOR, 1.18; 95% CI, 1.06-1.32) were independently associated with mortality. The AUC was 0.87 (95% CI, 0.78-0.96) for base deficit, increasing to 0.91 (95% CI, 0.83-0.99) with the addition of MBP.

Conclusion: Low MBP and high base deficit within ±4 hours of bloodstream infection onset identify preterm neonates at risk of mortality.
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http://dx.doi.org/10.1016/j.jpeds.2021.06.031DOI Listing
June 2021

COVID-19 pandemic and population-level pregnancy and neonatal outcomes: a living systematic review and meta-analysis.

Acta Obstet Gynecol Scand 2021 Oct 28;100(10):1756-1770. Epub 2021 Jun 28.

Department of Pediatrics, Mount Sinai Hospital, Toronto, Ontario, Canada.

Introduction: Conflicting reports of increases and decreases in rates of preterm birth (PTB) and stillbirth in the general population during the COVID-19 pandemic have surfaced. The objective of our study was to conduct a living systematic review and meta-analyses of studies reporting pregnancy and neonatal outcomes by comparing the pandemic and pre-pandemic periods.

Material And Methods: We searched PubMed and Embase databases, reference lists of articles published up until 14 May 2021 and included English language studies that compared outcomes between the COVID-19 pandemic time period and pre-pandemic time periods. Risk of bias was assessed using the Newcastle-Ottawa scale. We conducted random-effects meta-analysis using the inverse variance method.

Results: Thirty-seven studies with low-to-moderate risk of bias, reporting on 1 677 858 pregnancies during the pandemic period and 21 028 650 pregnancies during the pre-pandemic period, were included. There was a significant reduction in unadjusted estimates of PTB (28 studies, unadjusted odds ratio [uaOR] 0.94, 95% confidence [CI] 0.91-0.98) but not in adjusted estimates (six studies, adjusted OR [aOR] 0.95, 95% CI 0.80-1.13). The reduction was noted in studies from single centers/health areas (uaOR 0.90, 95% CI 0.86-0.94) but not in regional/national studies (uaOR 0.99, 95% CI 0.95-1.03). There was reduction in spontaneous PTB (five studies, uaOR 0.89, 95% CI 0.82-0.98) and induced PTB (four studies, uaOR 0.90, 95% CI 0.81-1.00). There was no reduction in PTB when stratified by gestational age <34, <32 or <28 weeks. There was no difference in stillbirths between the pandemic and pre-pandemic time periods (21 studies, uaOR 1.08, 95% CI 0.94-1.23; four studies, aOR 1.06, 95% CI 0.81-1.38). There was an increase in birthweight (six studies, mean difference 17 g, 95% CI 7-28 g) during the pandemic period. There was an increase in maternal mortality (four studies, uaOR 1.15, 95% CI 1.05-1.26), which was mostly influenced by one study from Mexico. There was significant publication bias for the outcome of PTB.

Conclusions: The COVID-19 pandemic time period may be associated with a reduction in PTB; however, referral bias cannot be excluded. There was no difference in stillbirth between the pandemic and pre-pandemic period.
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http://dx.doi.org/10.1111/aogs.14206DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8222877PMC
October 2021

Association of timing of birth with mortality among preterm infants born in Canada.

J Perinatol 2021 May 28. Epub 2021 May 28.

Department of Pediatrics, Montreal Children's Hospital, McGill University Health Centre, Montreal, QC, Canada.

Objective: To assess the association between time of birth and mortality among preterm infants.

Study Design: Population-based study of infants born 22-36 weeks gestation (GA) in Canada from 2010 to 2015 (n = 173 789). Multivariable logistic regression models assessed associations between timing of birth and mortality.

Result: Among infants 22-27 weeks GA, evening birth was associated with higher mortality than daytime birth (adjusted odds ratio [AOR] 1.14, 95% CI 1.01-1.29). Among infants 28-32 weeks GA and 33-36 weeks GA, night birth was associated with lower mortality than daytime birth (AOR 0.75, 95% CI 0.59-0.95; AOR 0.78, 95% CI 0.62-0.99, respectively). Sensitivity analysis excluding infants with major congenital anomaly revealed that associations between hour of birth and mortality among infants born 28-32 and 33-36 weeks GA decreased or were not statistically significant.

Conclusion: Higher mortality among extremely preterm infants during off-peak hours may suggest variations in available resources based on time of day.
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http://dx.doi.org/10.1038/s41372-021-01092-9DOI Listing
May 2021

Neurodevelopmental outcomes of singleton large for gestational age infants <29 weeks' gestation: a retrospective cohort study.

J Perinatol 2021 Jun 25;41(6):1313-1321. Epub 2021 May 25.

Section of Neonatology, Department of Pediatrics, Cumming School of Medicine, University of Calgary, Alberta, Canada.

Objective: To compare neurodevelopmental outcomes of large and appropriate for gestational age (LGA, AGA) infants <29 weeks' gestation at 18-24 months of corrected age.

Study Design: Retrospective cohort study using the Canadian Neonatal Network and Canadian Neonatal Follow-Up Network databases. Primary outcome was a composite of death or significant neurodevelopmental impairment (NDI), defined as severe cerebral palsy, Bayley III cognitive, language and motor scores of <70, need for hearing aids or cochlear implant and bilateral visual impairment. Univariate and multivariable logistic analyses were applied for outcomes.

Results: The study cohort comprised 170 LGA and 1738 AGA infants. There was no difference in significant NDI or individual components of the Bayley III between LGA and AGA groups. LGA was associated with the increased risk of death by follow-up, 44/170 (25.9%) vs. 320/1738 (18.4%) (aOR: 1.60 95% CI: 1.00-2.54).

Conclusions: Risk of NDI was similar between LGA and AGA infants.
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http://dx.doi.org/10.1038/s41372-021-01080-zDOI Listing
June 2021

Learning From Strengths: Improving Care by Comparing Perinatal Approaches Between Japan and Canada and Identifying Future Research Priorities.

J Obstet Gynaecol Can 2021 May 18. Epub 2021 May 18.

Department of Obstetrics & Gynecology, McMaster University, Hamilton, ON; Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, McMaster University Hamilton, ON. Electronic address:

Objective: Preterm birth (PTB) is the leading cause of infant morbidity and mortality worldwide. Canada and Japan each have strengths that can inform clinical decision-making, research, and health care policy regarding the prevention of PTB and its sequelae. Our objectives were to: 1) compare PTB rates, risk factors, management, and outcomes between Japan and Canada; 2) establish research priorities while fostering future collaborative opportunities; and 3) undertake knowledge translation of these findings.

Methods: We conducted a literature review to identify publications that examined PTB rates, risk factors, prevention and management techniques, and outcomes in Japan and Canada. We conducted site visits at 4 Japanese tertiary centres and held a collaborative stakeholder meeting of parents, neonatologists, maternal-fetal medicine specialists, and researchers.

Results: Japan reports lower rates of PTB, neonatal mortality, and several PTB risk factors than Canada. However, Canadian PTB data is population-based, whereas, in Japan, the rate of PTB is population-based, but outcomes are not. Rates of severe neurologic injury and necrotizing enterocolitis were lower in Japan, while Canada's rates of bronchopulmonary dysplasia and retinopathy of prematurity were lower. PTB prevention approaches differed, with less progesterone use in Japan and more long-term tocolysis. In Japan, there were lower rates of neonatal transfers and non-faculty overnight care, but also less use of antenatal corticosteroids and deferred cord clamping. Research priorities identified through the stakeholder meeting included early skin-to-skin contact, parental well-being after PTB, and transitions in care for the child.

Conclusion: We identified key differences between Japan and Canada in the factors affecting PTB management and patient outcomes, which can inform future research efforts.
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http://dx.doi.org/10.1016/j.jogc.2021.04.018DOI Listing
May 2021

The Importance of Harmonized Databases for Infants Born Extremely Preterm-If You Are Not Counted, You Are Not Accounted.

JAMA Netw Open 2021 May 3;4(5):e219709. Epub 2021 May 3.

Department of Pediatrics, Mount Sinai Hospital and University of Toronto, Toronto, Ontario, Canada.

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http://dx.doi.org/10.1001/jamanetworkopen.2021.9709DOI Listing
May 2021

Two-Thirds of Preterm Parents Would Participate in a Randomized Controlled Trial Comparing Double Doses of Steroids to a Single Dose and Placebo.

J Obstet Gynaecol Can 2021 May 6. Epub 2021 May 6.

Department of Obstetrics and Gynaecology, Mount Sinai Hospital and University of Toronto, Toronto, ON.

Animal research strongly suggests that a single dose of antenatal corticosteroids (ACS) is as effective as a double dose to mature preterm lungs; however, a human randomized controlled trial (RCT) is urgently needed. From August to November 2020, we conducted an online survey of Canadian parents of preterm infants. Survey respondents watched a parent-to-parent video introducing an RCT to study whether the standard double dose of ACS is non-inferior to a single dose (and matching placebo). Approximately two-thirds of respondents reported they were either likely or very likely to participate in the RCT, indicating high parental interest in and support for such a trial.
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http://dx.doi.org/10.1016/j.jogc.2021.03.020DOI Listing
May 2021

Rates and Determinants of Mother's Own Milk Feeding in Infants Born Very Preterm.

J Pediatr 2021 Sep 24;236:21-27.e4. Epub 2021 Apr 24.

Neonatal Nutrition and Gastroenterology Program, Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada. Electronic address:

Objectives: To examine rates and determinants of mother's own milk (MOM) feeding at hospital discharge in a cohort of infants born very preterm within the Canadian Neonatal Network (CNN).

Study Design: This was a population-based cohort study of infants born at <33 weeks of gestation and admitted to neonatal intensive care units (NICUs) participating in the CNN between January 1, 2015, and December 31, 2018. We examined the rates and determinants of MOM use at discharge home among the participating NICUs. We used multivariable logistic regression analysis to identify independent determinants of MOM feeding.

Results: Among the 6404 infants born very preterm and discharged home during the study period, 4457 (70%) received MOM or MOM supplemented with formula. Rates of MOM feeding at discharge varied from 49% to 87% across NICUs. Determinants associated with MOM feeding at discharge were gestational age 29-32 weeks compared with <26 weeks (aOR 1.56, 95% CI 1.25-1.93), primipara mothers (aOR 2.12, 95% CI 1.86-2.42), maternal diabetes (aOR 0.79, 95% CI 0.66-0.93), and maternal smoking (aOR 0.27, 95% CI 0.19-0.38). Receipt of MOM by day 3 of age was the major predictor of breast milk feeding at discharge (aOR 3.61, 95% CI 3.17-4.12).

Conclusions: Approximately two-thirds of infants born very preterm received MOM at hospital discharge, and rates varied across NICUs. Supporting mothers to provide breast milk in the first 3 days after birth may be associated with improved MOM feeding rates at discharge.
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http://dx.doi.org/10.1016/j.jpeds.2021.04.037DOI Listing
September 2021

Steroids for the Management of Neonates With Meconium Aspiration Syndrome: A Systematic Review and Meta-analysis.

Indian Pediatr 2021 04;58(4):370-376

Division of Neonatology, University of Toronto, and Department of Pediatrics, Mount Sinai Hospital, Toronto, Canada.

Background: Steroids are a potential treatment for pulmonary inflammation in meconium aspiration syndrome (MAS).

Objective: To assess the efficacy and safety of steroids for the management of neonates with MAS.

Design: Systematic review and meta-analysis of randomized controlled trials (RCT).

Data Sources And Selection Criteria: A systematic search of PubMed, Embase, Cochrane, and CINAHL was performed from database inception to May 2020 for trials assessing the efficacy of steroids (inhaled/systemic or both) in neonates with MAS. The primary outcome was in-hospital mortality, with secondary outcomes being length of hospital stay and duration of oxygen support.

Results: Nine RCTs (758 neonates) were included. Overall, steroids did not decrease in-hospital mortality (RR: 0.59; 95% CI 0.28 to 1.23; I2 = 0%; GRADE: low) nor had any effect on the secondary outcomes.

Conclusions: There is low quality of evidence that the administration of steroids is not associated with a reduction in mortality in infants with MAS. Further well-designed studies with low bias are needed to draw conclusions.
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April 2021

Comparison of High CPAP versus NIPPV in Preterm Neonates: A Retrospective Cohort Study.

Am J Perinatol 2021 Apr 14. Epub 2021 Apr 14.

Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.

Objective:  The aim of this study was to compare outcomes following receipt of high continuous positive airway pressure (CPAP) versus nasal intermittent positive pressure ventilation (NIPPV) in extremely preterm neonates.

Study Design:  We retrospectively compared outcomes of preterm neonates (22-28 weeks' gestation) following their first episode of either high CPAP (≥ 9 cmHO) or NIPPV. Primary outcome was failure of high CPAP or NIPPV within 7 days, as determined by either need for intubation or use of an alternate noninvasive mode.

Results:  During the 3-year study period, 53 infants received high CPAP, while 119 patients received NIPPV. There were no differences in the primary outcome (adjusted odds ratio 1.21; 95% confidence interval 0.49-3.01). The use of alternate mode of noninvasive support was higher with the use of high CPAP but no other outcome differences were noted.

Conclusion:  Based on this cohort, there was no difference in incidence of failure between high CPAP and NIPPV, although infants receiving high CPAP were more likely to require an alternate mode of noninvasive support.

Key Points: · Use of high CPAP pressures (defined as ≥9 cmH2O) is gradually increasing during care of preterm neonates.. · Limited data exists regarding its efficacy and safety.. · This study compares high CPAP with NIPPV, and demonstrates comparable short-term clinical outcomes..
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http://dx.doi.org/10.1055/s-0041-1727159DOI Listing
April 2021

Interrater agreement for sonographic stomach position classification in fetal diaphragmatic hernia across the North American Fetal Therapy Network.

Prenat Diagn 2021 Apr 5. Epub 2021 Apr 5.

The Fetal Center, Children's Memorial Hermann Hospital, University of Texas Health Science Center, Houston, Texas, USA.

Objective: To evaluate inter-rater agreement for sonographic classification of stomach position (as a surrogate for liver herniation) in fetal left congenital diaphragmatic hernia (LCDH) among: (i) fetal medicine specialists from the North American Fetal Therapy Network (NAFTNet) centers within and without the fetal endoscopic tracheal occlusion (FETO) consortium and in comparison to an expert external reviewer (ER1); and (iii) among two expert ERs (ER1 and ER2).

Methods: Forty-eight physicians from 26 NAFTNet centers and 2 ERs were asked to assess 13 sonographic clips of isolated LCDH and classify stomach position as "intra-abdominal," "anterior left chest," "mid to posterior left chest," or "retro-cardiac" based on the classification published by Basta et al. Interrater agreement was assessed by determining proportion of stomach position ratings concordant amongst NAFTNet participants and ER1. Agreement for stomach position between ERs was calculated using kappa statistics.

Results: Agreement for stomach position was 69% (39%-85%; n = 19) and 54% (23%-92%; n = 29) among FETO and non-FETO NAFTNet participants, respectively, when compared to ER1. Most disagreement in stomach position was related to a discrepancy of one position. ERs were in agreement for stomach position in 5 of 13 cases (38.5%) and inter-rater agreement was highest for "anterior" stomach position.

Conclusion: Interrater agreement for stomach position assessment in CDH was poor across NAFTNet and indeed amongst expert reviewers.
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http://dx.doi.org/10.1002/pd.5949DOI Listing
April 2021

Neurodevelopmental outcomes of preterm infants conceived by assisted reproductive technology.

Am J Obstet Gynecol 2021 09 30;225(3):276.e1-276.e9. Epub 2021 Mar 30.

Department of Pediatrics, Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada. Electronic address:

Background: There have been concerns about the development of children conceived through assisted reproductive technology. Despite multiple studies investigating the outcomes of assisted conception, data focusing specifically on the neurodevelopmental outcomes of infants conceived through assisted reproductive technology and born preterm are limited.

Objective: This study aimed to evaluate and compare the neurodevelopmental outcomes of preterm infants born at <29 weeks' gestation at 18 to 24 months' corrected age who were conceived through assisted reproductive technology and those who were conceived naturally.

Study Design: This retrospective cohort study included inborn, nonanomalous infants, born at <29 weeks' gestation between January 1, 2010, and December 31, 2016, who had a neurodevelopmental assessment at 18 to 24 months' corrected age at any of the 10 Canadian Neonatal Follow-Up Network clinics. The primary outcome was neurodevelopmental impairment at 18 to 24 months, defined as the presence of any of the following: cerebral palsy; Bayley-III cognitive, motor, or language composite score of <85; sensorineural or mixed hearing loss; and unilateral or bilateral visual impairment. Secondary outcomes included mortality, composite of mortality or neurodevelopmental impairment, significant neurodevelopmental impairment, and each component of the primary outcome. We compared outcomes between infants conceived through assisted reproductive technology and those conceived naturally, using bivariate and multivariable analyses after adjustment.

Results: Of the 4863 eligible neonates, 651 (13.4%) were conceived using assisted reproductive technology. Maternal age; education level; and rates of diabetes mellitus, receipt of antenatal corticosteroids, and cesarean delivery were higher in the assisted reproduction group than the natural conception group. Neonatal morbidity and death rates were similar except for intraventricular hemorrhage, which was lower in the assisted reproduction group (33% [181 of 546] vs 39% [1284 of 3318]; P=.01). Of the 4176 surviving infants, 3386 (81%) had a follow-up outcome at 18 to 24 months' corrected age. Multivariable logistic regression adjusting for gestational age, antenatal steroids, sex, small for gestational age, multiple gestations, mode of delivery, maternal age, maternal education, pregnancy-induced hypertension, maternal diabetes mellitus, and smoking showed that infants conceived through assisted reproduction was associated with lower odds of neurodevelopmental impairment (adjusted odds ratio, 0.67; 95% confidence interval, 0.52-0.86) and the composite of death or neurodevelopmental impairment (adjusted odds ratio, 0.67; 95% confidence interval, 0.54-0.84). Conception through assisted reproductive technology was associated with decreased odds of a Bayley-III composite cognitive score of <85 (adjusted odds ratio, 0.68; 95% confidence interval, 0.48-0.99) and composite language score of <85 (adjusted odds ratio, 0.67; 95% confidence interval, 0.50-0.88).

Conclusion: Compared with natural conception, assisted conception was associated with lower odds of adverse neurodevelopmental outcomes, especially cognitive and language outcomes, at 18 to 24 months' corrected age among preterm infants born at <29 weeks' gestation. Long-term follow-up studies are required to assess the risks of learning disabilities and development of complex visual-spatial and processing skills in these children as they reach school age.
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September 2021

Multicentre prospective observational study exploring the predictive value of functional echocardiographic indices for early identification of preterm neonates at risk of developing chronic pulmonary hypertension secondary to chronic neonatal lung disease.

BMJ Open 2021 03 31;11(3):e044924. Epub 2021 Mar 31.

Paediatrics, Sinai Health System, Toronto, Ontario, Canada

Introduction: Although chronic pulmonary hypertension (cPH) secondary to chronic neonatal lung disease is associated with increased mortality and respiratory and neurodevelopmental morbidities, late diagnosis (typically ≥36 weeks postmenstrual age, PMA) and the use of qualitative echocardiographic diagnostic criterion (flat interventricular septum in systole) remain significant limitations in clinical care. Our objective in this study is to evaluate the utility of relevant quantitative echocardiographic indices to identify cPH in preterm neonates, early in postnatal course and to develop a diagnostic test based on the best combination of markers.

Methods And Analysis: In this ongoing international prospective multicentre observational diagnostic accuracy study, we aim to recruit 350 neonates born <27 weeks PMA and/or birth weight <1000 g and perform echocardiograms in the third week of age and at 32 weeks PMA (early diagnostic assessments, EDA) in addition to the standard diagnostic assessment (SDA) for cPH at 36 weeks PMA. Predefined echocardiographic markers under investigation will be measured at each EDA and examined to create a scoring system to identify neonates who subsequently meet the primary outcome of cPH/death at SDA. Diagnostic test characteristics will be defined for each EDA. Pulmonary artery acceleration time and tricuspid annular plane systolic excursion are the primary markers of interest.

Ethics And Dissemination: Ethics approval has been received by the Mount Sinai Hospital Research Ethics Board (REB) (#16-0111-E), Sunnybrook Health Sciences Centre REB (#228-2016), NHS Health Research Authority (IRAS 266498), University of Iowa Human Subjects Office/Institutional Review Board (201903736), Rotunda Hospital Research and Ethics Committee (REC-2019-008), and UBC Children's and Women's REB (H19-02738), and is under review at Boston Children's Hospital Institutional Review Board. Study results will be disseminated to participating families in lay format, presented to the scientific community at paediatric and critical care conferences and published in relevant peer-reviewed journals.

Trail Registration Number: NCT04402645.
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http://dx.doi.org/10.1136/bmjopen-2020-044924DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8016080PMC
March 2021

Consensus Approach for Standardizing the Screening and Classification of Preterm Brain Injury Diagnosed With Cranial Ultrasound: A Canadian Perspective.

Front Pediatr 2021 8;9:618236. Epub 2021 Mar 8.

Department of Pediatrics, Mount Sinai hospital, Toronto, ON, Canada.

Acquired brain injury remains common in very preterm infants and is associated with significant risks for short- and long-term morbidities. Cranial ultrasound has been widely adopted as the first-line neuroimaging modality to study the neonatal brain. It can reliably detect clinically significant abnormalities that include germinal matrix and intraventricular hemorrhage, periventricular hemorrhagic infarction, post-hemorrhagic ventricular dilatation, cerebellar hemorrhage, and white matter injury. The purpose of this article is to provide a consensus approach for detecting and classifying preterm brain injury to reduce variability in diagnosis and classification between neonatologists and radiologists. Our overarching goal with this work was to achieve homogeneity between different neonatal intensive care units across a large country (Canada) with regards to classification, timing of brain injury screening and frequency of follow up imaging. We propose an algorithmic approach that can help stratify different grades of germinal matrix-intraventricular hemorrhage, white matter injury, and ventricular dilatation in very preterm infants.
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http://dx.doi.org/10.3389/fped.2021.618236DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7982529PMC
March 2021

Association of Co-Exposure of Antenatal Steroid and Prophylactic Indomethacin with Spontaneous Intestinal Perforation.

J Pediatr 2021 Aug 16;235:34-41.e1. Epub 2021 Mar 16.

Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada; Maternal-infant Care Research Center, Mount Sinai Hospital, Toronto, Ontario, Canada; Department of Pediatrics, Mount Sinai Hospital, Toronto, Ontario, Canada. Electronic address:

Objective: To evaluate the association of a combined exposure to antenatal steroids and prophylactic indomethacin with the outcome of spontaneous intestinal perforation (SIP) among neonates born at <26 weeks of gestation or <750 g birth weight.

Study Design: We conducted a retrospective study of preterm infants admitted to Canadian Neonatal Network units between 2010 and 2018. Infants were classified into 2 groups based on receipt of antenatal steroids; the latter subgrouped as recent (≤7 days before birth) or latent (>7 days before birth) exposures. The co-exposure was prophylactic indomethacin. The primary outcome was SIP. Multivariable logistic regression analysis was used to calculate aORs.

Results: Among 4720 eligible infants, 4121 (87%) received antenatal steroids and 1045 (22.1%) received prophylactic indomethacin. Among infants exposed to antenatal steroids, those who received prophylactic indomethacin had higher odds of SIP (aOR 1.61, 95% CI 1.14-2.28) compared with no prophylactic indomethacin. Subgroup analyses revealed recent antenatal steroids exposure with prophylactic indomethacin had higher odds of SIP (aOR 1.67, 95% CI 1.15-2.43), but latent antenatal steroids exposure with prophylactic indomethacin did not (aOR 1.24, 95% CI 0.48-3.21), compared with the respective groups with no prophylactic indomethacin. Among those not exposed to antenatal steroids, mortality was lower among those who received prophylactic indomethacin (aOR 0.45, 95% CI 0.28-0.73) compared with no prophylactic indomethacin.

Conclusions: In preterm neonates of <26 weeks of gestation or birth weight <750 g, co-exposure of antenatal steroids and prophylactic indomethacin was associated with SIP, especially if antenatal steroids was received within 7 days before birth. Among those unexposed to antenatal steroids, prophylactic indomethacin was associated with lower odds of mortality.
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http://dx.doi.org/10.1016/j.jpeds.2021.03.012DOI Listing
August 2021

Gestational Age-Dependent Variations in Effects of Prophylactic Indomethacin on Brain Injury and Intestinal Injury.

J Pediatr 2021 Aug 7;235:26-33.e2. Epub 2021 Mar 7.

Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada. Electronic address:

Objective: To evaluate the impact of prophylactic indomethacin on early death (<10 days after birth) or severe neurologic injury and on early death or spontaneous intestinal perforation by completed weeks of gestational age in neonates born <29 weeks of gestation.

Study Design: This was a multicenter, retrospective cohort study of neonates (n = 12 515) born at 23 weeks of gestational age, admitted to neonatal intensive care units participating in the Canadian Neonatal Network who received prophylactic indomethacin started within the first 12 hours after birth. Univariate and multivariate analysis compared the composite outcomes of early death or severe neurologic injury and early death or spontaneous intestinal perforation.

Results: Of 12 515 eligible neonates, 1435 (11.5%) were exposed to prophylactic indomethacin; recipients were of lower gestational age and birth weight and had greater severity of illness (Score of Neonatal Acute Physiology with Perinatal Extension) on admission compared with nonrecipients. After we adjusted for confounders, prophylactic indomethacin was associated with reduced odds of early death or severe neurologic injury and early death or spontaneous intestinal perforation in neonates born at 23-24 weeks of gestational age. However, prophylactic indomethacin was associated with increased odds of early mortality or spontaneous intestinal perforation for neonates born at 26-28 weeks of gestational age.

Conclusions: Prophylactic indomethacin use was associated with benefit in neonates born at 23-24 weeks of gestational age, but with harm at 26-28 weeks of gestational age. Given the observation of significantly improved survival, a randomized controlled trial is needed to investigate the effect of prophylactic indomethacin in babies born at 23-25 weeks of gestational age.
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August 2021

Association of Umbilical Cord Management Strategies With Outcomes of Preterm Infants: A Systematic Review and Network Meta-analysis.

JAMA Pediatr 2021 Apr 5;175(4):e210102. Epub 2021 Apr 5.

Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.

Importance: It is unclear which umbilical cord management strategy is the best for preventing mortality and morbidities in preterm infants.

Objective: To systematically review and conduct a network meta-analysis comparing 4 umbilical cord management strategies for preterm infants: immediate umbilical cord clamping (ICC), delayed umbilical cord clamping (DCC), umbilical cord milking (UCM), and UCM and DCC.

Data Sources: PubMed, Embase, CINAHL, and Cochrane CENTRAL databases were searched from inception until September 11, 2020.

Study Selection: Randomized clinical trials comparing different umbilical cord management strategies for preterm infants were included.

Data Extraction And Synthesis: Data were extracted for bayesian random-effects meta-analysis to estimate the relative treatment effects (odds ratios [OR] and 95% credible intervals [CrI]) and surface under the cumulative ranking curve values.

Main Outcomes And Measures: The primary outcome was predischarge mortality. The secondary outcomes were intraventricular hemorrhage, severe intraventricular hemorrhage, need for packed red blood cell transfusion, and other neonatal morbidities. Confidence in network meta-analysis software was used to assess the quality of evidence and grade outcomes.

Results: Fifty-six studies enrolled 6852 preterm infants. Compared with ICC, DCC was associated with lower odds of mortality (22 trials, 3083 participants; 7.6% vs 5.0%; OR, 0.64; 95% CrI, 0.39-0.99), intraventricular hemorrhage (25 trials, 3316 participants; 17.8% vs 15.4%; OR, 0.73; 95% CrI, 0.54-0.97), and need for packed red blood cell transfusion (18 trials, 2904 participants; 46.9% vs 38.3%; OR, 0.48; 95% CrI, 0.32-0.66). Compared with ICC, UCM was associated with lower odds of intraventricular hemorrhage (10 trials, 645 participants; 22.5% vs 16.2%; OR, 0.58; 95% CrI, 0.38-0.84) and need for packed red blood cell transfusion (9 trials, 688 participants; 47.3% vs 32.3%; OR, 0.36; 95% CrI, 0.23-0.53), with no significant differences for other secondary outcomes. There was no significant difference between UCM and DCC for any outcome.

Conclusions And Relevance: Compared with ICC, DCC was associated with the lower odds of mortality in preterm infants. Compared with ICC, DCC and UCM were associated with reductions in intraventricular hemorrhage and need for packed red cell transfusion. There was no significant difference between UCM and DCC for any outcome. Further studies directly comparing DCC and UCM are needed.
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http://dx.doi.org/10.1001/jamapediatrics.2021.0102DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7941254PMC
April 2021

Variations in Neonatal Length of Stay of Babies Born Extremely Preterm: An International Comparison Between iNeo Networks.

J Pediatr 2021 06 15;233:26-32.e6. Epub 2021 Feb 15.

UK Neonatal Collaborative, Neonatal Data Analysis Unit, Section of Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, United Kingdom.

Objective: To compare length of stay (LOS) in neonatal care for babies born extremely preterm admitted to networks participating in the International Network for Evaluating Outcomes of Neonates (iNeo).

Study Design: Data were extracted for babies admitted from 2014 to 2016 and born at 24 to 28 weeks of gestational age (n = 28 204). Median LOS was calculated for each network for babies who survived and those who died while in neonatal care. A linear regression model was used to investigate differences in LOS between networks after adjusting for gestational age, birth weight z score, sex, and multiplicity. A sensitivity analysis was conducted for babies who were discharged home directly.

Results: Observed median LOS for babies who survived was longest in Japan (107 days); this result persisted after adjustment (20.7 days more than reference, 95% CI 19.3-22.1). Finland had the shortest adjusted LOS (-4.8 days less than reference, 95% CI -7.3 to -2.3). For each week's increase in gestational age at birth, LOS decreased by 12.1 days (95% CI -12.3 to -11.9). Multiplicity and male sex predicted mean increases in LOS of 2.6 (95% CI 2.0-3.2) and 2.1 (95% CI 1.6-2.6) days, respectively.

Conclusions: We identified between-network differences in LOS of up to 3 weeks for babies born extremely preterm. Some of these may be partly explained by differences in mortality, but unexplained variations also may be related to differences in clinical care practices and healthcare systems between countries.
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June 2021

Protocol for a cluster randomised trial evaluating a multifaceted intervention starting preconceptionally-Early Interventions to Support Trajectories for Healthy Life in India (EINSTEIN): a Healthy Life Trajectories Initiative (HeLTI) Study.

BMJ Open 2021 02 16;11(2):e045862. Epub 2021 Feb 16.

MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.

Introduction: The Healthy Life Trajectories Initiative is an international consortium comprising four harmonised but independently powered trials to evaluate whether an integrated intervention starting preconceptionally will reduce non-communicable disease risk in their children. This paper describes the protocol of the India study.

Methods And Analysis: The study set in rural Mysore will recruit ~6000 married women over the age of 18 years. The village-based cluster randomised design has three arms (preconception, pregnancy and control; 35 villages per arm). The longitudinal multifaceted intervention package will be delivered by community health workers and comprise: (1) measures to optimise nutrition; (2) a group parenting programme integrated with cognitive-behavioral therapy; (3) a lifestyle behaviour change intervention to support women to achieve a diverse diet, exclusive breast feeding for the first 6 months, timely introduction of diverse and nutritious infant weaning foods, and adopt appropriate hygiene measures; and (4) the reduction of environmental pollution focusing on indoor air pollution and toxin avoidance.The primary outcome is adiposity in children at age 5 years, measured by fat mass index. We will report on a host of intermediate and process outcomes. We will collect a range of biospecimens including blood, urine, stool and saliva from the mothers, as well as umbilical cord blood, placenta and specimens from the offspring.An intention-to-treat analysis will be adopted to assess the effect of interventions on outcomes. We will also undertake process and economic evaluations to determine scalability and public health translation.

Ethics And Dissemination: The study has been approved by the institutional ethics committee of the lead institute. Findings will be published in peer-reviewed journals. We will interact with policy makers at local, national and international agencies to enable translation. We will also share the findings with the participants and local community through community meetings, newsletters and local radio.

Trial Registration Number: ISRCTN20161479, CTRI/2020/12/030134; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2020-045862DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7888364PMC
February 2021

SARS-CoV-2 genome and antibodies in breastmilk: a systematic review and meta-analysis.

Arch Dis Child Fetal Neonatal Ed 2021 Sep 10;106(5):514-521. Epub 2021 Feb 10.

Department of Pediatrics, Sinai Health System, Toronto, Ontario, Canada

Objective: To systematically review and meta-analyse the rate of SARS-CoV-2 genome identification and the presence of SARS-CoV-2 antibodies in breastmilk of mothers with COVID-19.

Design: A systematic review of studies published between January 2019 and October 2020 without study design or language restrictions.

Setting: Data sourced from Ovid Embase Classic+Embase, PubMed, Web of Science, Scopus, relevant bibliographies and the John Hopkins University COVID-19 database.

Patients: Mothers with confirmed COVID-19 and breastmilk tested for SARS-CoV-2 by RT-PCR or for anti-SARS-CoV-2 antibodies.

Main Outcome Measures: Presence of SARS-CoV-2 genome and antibodies in breastmilk.

Results: We included 50 articles. Twelve out of 183 women from 48 studies were positive for SARS-CoV-2 genome in their breastmilk (pooled proportion 5% (95% CI 2% to 15%; I=48%)). Six infants (50%) of these 12 mothers tested positive for SARS-CoV-2, with one requiring respiratory support. Sixty-one out of 89 women from 10 studies had anti-SARS-CoV-2 antibody in their breastmilk (pooled proportion 83% (95% CI 32% to 98%; I=88%)). The predominant antibody detected was IgA.

Conclusions: SARS-CoV-2 genome presence in breastmilk is uncommon and is associated with mild symptoms in infants. Anti-SARS-CoV-2 antibodies may be a more common finding. Considering the low proportion of SARS-CoV-2 genome detected in breastmilk and its lower virulence, mothers with COVID-19 should be supported to breastfeed.
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September 2021

Protocol for a randomised trial evaluating a preconception-early childhood telephone-based intervention with tailored e-health resources for women and their partners to optimise growth and development among children in Canada: a Healthy Life Trajectory Initiative (HeLTI Canada).

BMJ Open 2021 02 10;11(2):e046311. Epub 2021 Feb 10.

Lawrence S. Bloomburg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.

Introduction: The 'Developmental Origins of Health and Disease' hypothesis suggests that a healthy trajectory of growth and development in pregnancy and early childhood is necessary for optimal health, development and lifetime well-being. The purpose of this paper is to present the protocol for a randomised controlled trial evaluating a preconception-early childhood telephone-based intervention with tailored e-health resources for women and their partners to optimise growth and development among children in Canada: a Healthy Life Trajectory Initiative (HeLTI Canada). The primary objective of HeLTI Canada is to determine whether a 4-phase 'preconception to early childhood' lifecourse intervention can reduce the rate of child overweight and obesity. Secondary objectives include improved child: (1) growth trajectories; (2) cardiometabolic risk factors; (3) health behaviours, including nutrition, physical activity, sedentary behaviour and sleep; and (4) development and school readiness at age 5 years.

Method And Analysis: A randomised controlled multicentre trial will be conducted in two of Canada's highly populous provinces-Alberta and Ontario-with 786 nulliparous (15%) and 4444 primiparous (85%) women, their partners and, when possible, the first 'sibling child.' The intervention is telephone-based collaborative care delivered by experienced public health nurses trained in healthy conversation skills that includes detailed risk assessments, individualised structured management plans, scheduled follow-up calls, and access to a web-based app with individualised, evidence-based resources. An 'index child' conceived after randomisation will be followed until age 5 years and assessed for the primary and secondary outcomes. Pregnancy, infancy (age 2 years) and parental outcomes across time will also be assessed.

Ethics And Dissemination: The study has received approval from Clinical Trials Ontario (CTO 1776). The findings will be published in peer-reviewed journals and disseminated to policymakers at local, national and international agencies. Findings will also be shared with study participants and their communities.

Trial Registration Number: ISRCTN13308752; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2020-046311DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7878148PMC
February 2021

Risk factors for postpartum depressive symptoms among fathers: A systematic review and meta-analysis.

Acta Obstet Gynecol Scand 2021 07 24;100(7):1186-1199. Epub 2021 Feb 24.

Department of Pediatrics, Mount Sinai Hospital, Toronto, ON, Canada.

Introduction: The transition to parenthood is a major life change that may affect the mental well-being of both mothers and fathers and place them at an increased risk for depression. The objective of our study was to systematically review the literature and identify factors associated with postpartum depressive symptoms in fathers.

Material And Methods: Searches were conducted in PubMed, PsychInfo, Embase, and CINAHL to identify studies published until March 2020. Studies that reported factors associated with depression among fathers were included. The data from these studies were extracted independently by two authors with disagreements resolved by a third author and consensus. The odds ratio (OR) was used as a measure of association between the risk factor and the primary outcome: depression within the first 12 months following childbirth among fathers diagnosed using any method. Summary estimates were calculated using a random effects model. The associations between the risk factors and depressive symptoms were evaluated.

Results: The search identified 1040 reports. After screening titles and abstracts, 62 full-text articles were assessed for eligibility and 25 studies involving 13 972 fathers were included in the systematic review. Fathers with a prior mental health illness episode had higher odds of developing depressive symptoms than those with no mental health history (eight studies, n = 3515, pooled OR 6.77, 95% CI 5.07-9.04; I  = 0%). Other significant risk factors included relationship dissatisfaction (eight studies, n = 6924, pooled OR 1.53, 95% CI 1.29-1.81; I  = 93%), maternal depression (seven studies, n = 6661, pooled OR 1.66, 95% CI 1.27-2.17; I  = 88%), financial instability (five studies, n = 3052, pooled OR 2.24, 95% CI 1.44-3.48; I  = 74%), paternal unemployment (three studies, n = 1505, pooled OR 6.61, 95% CI 1.94-22.54; I  = 59%), low education level (two studies, n = 1697, pooled OR 3.56, 95% CI 1.06-11.97; I  = 88%), and perceived stress (two studies, n = 692, pooled OR 1.06, 95% CI 1.02-1.11; I  = 5%). Lack of support and low parenting self-efficacy were also associated with paternal postpartum depressive symptoms.

Conclusions: A history of paternal mental illness, maternal depression, and diverse psychosocial factors were associated with depressive symptoms among fathers postnatally. These findings can guide the development of family-level interventions for early identification and treatment and social media campaigns to promote help-seeking behaviors and engagement in preventive strategies.
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http://dx.doi.org/10.1111/aogs.14109DOI Listing
July 2021

Inter-center variability in neonatal outcomes of preterm infants: A longitudinal evaluation of 298 neonatal units in 11 countries.

Semin Fetal Neonatal Med 2021 Feb 21;26(1):101196. Epub 2021 Jan 21.

Department of Pediatrics and Maternal-infant Care Research Centre, Mount Sinai Hospital, 600 University Avenue, Toronto, Ontario, Canada, M5G 1X5. Electronic address:

Collaboration and cooperation of clinicians and neonatal units at regional, national, and international levels are key features of many networks or systems that aim to improve neonatal outcomes. Network performance is typically assessed by comparing individual, unit-level outcomes. In this paper, we provide insight into another dimension, i.e., inter-center outcome variation in 10 national/regional neonatal collaborations from 11 high-income countries. We illustrate the use of coefficients of variation for evaluation of mortality and a composite outcome of mortality, severe neurological injury, treated retinopathy of prematurity, and bronchopulmonary dysplasia, as a measure of inter-center variation. These inter-center variation estimates could help to identify areas of opportunities and challenges for each country/region; they also provide "macro"-level evaluations that can be useful for clinicians, administrators, managers and policy makers.
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February 2021
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