Publications by authors named "Sara B DeMauro"

77 Publications

Initial Laparotomy Versus Peritoneal Drainage in Extremely Low Birthweight Infants With Surgical Necrotizing Enterocolitis or Isolated Intestinal Perforation: A Multicenter Randomized Clinical Trial.

Ann Surg 2021 10;274(4):e370-e380

University of Rochester School of Medicine and Dentistry, Rochester, NY.

Objective: The aim of this study was to determine which initial surgical treatment results in the lowest rate of death or neurodevelopmental impairment (NDI) in premature infants with necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP).

Summary Background Data: The impact of initial laparotomy versus peritoneal drainage for NEC or IP on the rate of death or NDI in extremely low birth weight infants is unknown.

Methods: We conducted the largest feasible randomized trial in 20 US centers, comparing initial laparotomy versus peritoneal drainage. The primary outcome was a composite of death or NDI at 18 to 22 months corrected age, analyzed using prespecified frequentist and Bayesian approaches.

Results: Of 992 eligible infants, 310 were randomized and 96% had primary outcome assessed. Death or NDI occurred in 69% of infants in the laparotomy group versus 70% with drainage [adjusted relative risk (aRR) 1.0; 95% confidence interval (CI): 0.87-1.14]. A preplanned analysis identified an interaction between preoperative diagnosis and treatment group (P = 0.03). With a preoperative diagnosis of NEC, death or NDI occurred in 69% after laparotomy versus 85% with drainage (aRR 0.81; 95% CI: 0.64-1.04). The Bayesian posterior probability that laparotomy was beneficial (risk difference <0) for a preoperative diagnosis of NEC was 97%. For preoperative diagnosis of IP, death or NDI occurred in 69% after laparotomy versus 63% with drainage (aRR, 1.11; 95% CI: 0.95-1.31); Bayesian probability of benefit with laparotomy = 18%.

Conclusions: There was no overall difference in death or NDI rates at 18 to 22 months corrected age between initial laparotomy versus drainage. However, the preoperative diagnosis of NEC or IP modified the impact of initial treatment.
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http://dx.doi.org/10.1097/SLA.0000000000005099DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8439547PMC
October 2021

Is it time to study routine car seat tolerance screening in a randomized controlled trial? An international survey of current practice and clinician equipoise.

J Perinatol 2021 Aug 27. Epub 2021 Aug 27.

Department of Pediatrics, Division of Neonatology, The Children's Hospital of Philadelphia and The University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.

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http://dx.doi.org/10.1038/s41372-021-01167-7DOI Listing
August 2021

Survival and decannulation across indications for infant tracheostomy: a twelve-year single-center cohort study.

J Perinatol 2021 Aug 17. Epub 2021 Aug 17.

Division of Neonatology, Children's Hospital of Philadelphia, Philadelphia, PA, USA.

Objective: Describe survival and decannulation following infant tracheostomy based on indication for tracheostomy placement.

Study Design: Retrospective cohort study of infants who received tracheostomy at a single pediatric hospital over a twelve-year period. Primary and secondary indications were categorized into pulmonary, anatomic, cardiac, neurologic/musculoskeletal, and others.

Results: A total of 378 infants underwent tracheostomy; 323 had sufficient data to be included in analyses of post-discharge outcomes. Overall mortality was 26.3%; post-operative and post-discharge mortality differed across primary indications (P = 0.03 and P = 0.005). Among survivors, 69.3% decannulated at a median age of 3.0 years (IQR 2.3, 4.5 years). Decannulation among survivors varied across primary indications (P = 0.002), ranging from 17% to 75%. In multivariable analysis, presence of a neurologic or musculoskeletal indication for tracheostomy was a significant negative predictor of future decannulation (aOR 0.10 [95% CI 0.02-0.44], P = 0.003).

Conclusions: Early childhood outcomes vary across indications for infant tracheostomy.
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http://dx.doi.org/10.1038/s41372-021-01181-9DOI Listing
August 2021

Evolving Respiratory Care of the Preterm Infant.

JAMA Pediatr 2021 Jul 6. Epub 2021 Jul 6.

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.

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http://dx.doi.org/10.1001/jamapediatrics.2021.1918DOI Listing
July 2021

Telemedicine use in neonatal follow-up programs - What can we do and what we can't - Lessons learned from COVID-19.

Semin Perinatol 2021 08 6;45(5):151430. Epub 2021 Apr 6.

Children's Hospital of Philadelphia and University of Pennsylvania Perelman School of Medicine, 2716 South Street, Philadelphia, PA 19146, United States.

Little empirical data support the use of telemedicine to provide medical and developmental follow-up care to preterm and high-risk infants after hospital discharge. Nevertheless, the COVID-19 pandemic temporarily rendered telemedicine the only means by which to provide essential follow-up care to this population. In this article we discuss our institution's experience with rapid implementation of telemedicine in a multi-site neonatal follow-up program as well as benefits and limitations of the use of telemedicine in this context. Finally, we discuss the current problems that must be solved in order to optimize telemedicine as a tool for providing comprehensive, multidisciplinary medical and developmental care to high risk infants and their families.
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http://dx.doi.org/10.1016/j.semperi.2021.151430DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8022519PMC
August 2021

The relationship of neurodevelopmental impairment to concurrent early childhood outcomes of extremely preterm infants.

J Perinatol 2021 Sep 23;41(9):2270-2278. Epub 2021 Mar 23.

Stead Family Department of Pediatrics, University of Iowa, Iowa, IA, USA.

Objective: Determine how neurodevelopmental impairment (NDI) relates to concurrent outcomes for children born extremely preterm.

Study Design: Retrospective cohort study children born 22 0/7-26 6/7 weeks' gestation at NICHD Neonatal Research Network hospitals. Outcomes were ascertained at 18-22 months' corrected age.

Result: Of 6562 children, 2618 (40%) died and 441 (7%) had no follow-up. Among the remaining 3483 children, 825 (24%), 1576 (45%), 657 (19%), and 425 (12%) had no, potential/mild, moderate, and severe NDI, respectively. Rehospitalization, respiratory medications, surgery, and medical support services were associated with greater NDI severity but affected >10% of children without NDI. Rehospitalization occurred in 40% of children with no NDI (mean (SD): 1.7 (1.3) episodes).

Conclusion: Medical, functional, and social outcomes at 18-22 months' corrected age were associated with NDI; however, many children without NDI were affected. These data should contribute to counseling families and the design of studies for childhood outcomes beyond NDI.
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http://dx.doi.org/10.1038/s41372-021-00999-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7985590PMC
September 2021

Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial.

J Perinatol 2021 Aug 23;41(8):2072-2087. Epub 2021 Mar 23.

Department of Ophthalmology and Visual Science, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, USA.

Objective: This study evaluates the 24-month follow-up for the NICHD Neonatal Research Network (NRN) Inositol for Retinopathy Trial.

Study Design: Bayley Scales of Infants Development-III and a standardized neurosensory examination were performed in infants enrolled in the main trial. Moderate/severe NDI was defined as BSID-III Cognitive or Motor composite score <85, moderate or severe cerebral palsy, blindness, or hearing loss that prevents communication despite amplification were assessed.

Results: Primary outcome was determined for 605/638 (95%). The mean gestational age was 25.8 ± 1.3 weeks and mean birthweight was 805 ± 192 g. Treatment group did not affect the risk for the composite outcome of death or survival with moderate/severe NDI (60% vs 56%, p = 0.40).

Conclusions: Treatment group did not affect the risk of death or survival with moderate/severe NDI. Despite early termination, this study represents the largest RCT of extremely preterm infants treated with myo-inositol with neurodevelopmental outcome data.
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http://dx.doi.org/10.1038/s41372-021-01018-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8349854PMC
August 2021

Neurodevelopmental outcomes of infants with bronchopulmonary dysplasia.

Authors:
Sara B DeMauro

Pediatr Pulmonol 2021 Mar 21. Epub 2021 Mar 21.

Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.

Preterm infants with bronchopulmonary dysplasia (BPD), and particularly those who develop the most severe forms of chronic lung disease during the neonatal period, are at high risk for poor developmental outcomes throughout childhood. Infants who require mechanical ventilation at 36 weeks post-menstrual age have significantly increased odds for cerebral palsy, developmental delay at 2 years, and poor academic achievement and low intelligence quotient in adolescence. Over the past several decades, many therapies and care strategies, including steroids, continuous positive airway pressure, surfactant, and other medications have been introduced into clinical practice. These approaches have changed the epidemiology of BPD in very preterm infants. However, BPD remains common and strongly associated with poor development throughout childhood. Only caffeine has been proven to reduce BPD and improve childhood developmental outcomes. In future research, it will be essential to better understand the developmental sequelae of BPD beyond school age and to test interventions to improve developmental trajectories in this population. As new management strategies for BPD are developed, it will be essential to rigorously evaluate both short-term and long-term effects before they are introduced into routine neonatal practice.
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http://dx.doi.org/10.1002/ppul.25381DOI Listing
March 2021

Goals of Care Discussions and Moral Distress Among Neonatal Intensive Care Unit Staff.

J Pain Symptom Manage 2021 Sep 28;62(3):529-536. Epub 2021 Jan 28.

Division of Neonatology, Department of Pediatrics, The Children's Hospital of Philadelphia and University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.

Context: The relationship between quality of Goals of Care (GOC) conversations and moral distress among neonatal intensive care unit (NICU) providers is not known.

Objectives: We sought 1) to explore levels of moral distress in providers, 2) to evaluate how staff moral distress changes in relation to GOC discussions, and 3) to identify elements of GOC discussions associated with change in moral distress. We hypothesized that staff moral distress would change after GOC discussions and that change would vary with presence of key discussion elements.

Methods: Prospective cohort study in a level IV NICU in an urban teaching hospital. We administered validated instruments at baseline and following GOC discussions including the Moral Distress Thermometer (MDT) and Williams Instrument (a measure of end-of-life care) to physicians, nurses, and social workers.

Results: We collected data on 79 GOC conversations over a 1-year period from 2018 to 2019. Most providers experienced an increase in moral distress following a GOC discussion. Providers experienced an average increase in moral distress, as measured by the MDT, of 0.84 (+/-3.15; P = 0.002). Physicians experienced an average change in moral distress of 1.1 (+/-3.52; P = 0.01) while nurses experienced an average change of 0.55 (+/-2.66; P = 0.07). Several elements of discussions were associated with the degree of increase in moral distress after the conversation.

Conclusion: Change in moral distress among providers may be a useful metric of quality of GOC discussions. There are identifiable elements of GOC conversations that are associated with high-quality discussions. These elements warrant further study.
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http://dx.doi.org/10.1016/j.jpainsymman.2021.01.124DOI Listing
September 2021

Neurodevelopmental outcomes following neonatal late-onset sepsis and blood culture-negative conditions.

Arch Dis Child Fetal Neonatal Ed 2021 Sep 21;106(5):467-473. Epub 2021 Jan 21.

Pediatrics, Neonatology, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.

Objective: Determine risk of death or neurodevelopmental impairment (NDI) in infants with late-onset sepsis (LOS) versus late-onset, antibiotic-treated, blood culture-negative conditions (LOCNC).

Design: Retrospective cohort study.

Setting: 24 neonatal centres.

Patients: Infants born 1/1/2006-31/12/2014, at 22-26 weeks gestation, with birth weight 401-1000 g and surviving >7 days were included. Infants with early-onset sepsis, necrotising enterocolitis, intestinal perforation or both LOS and LOCNC were excluded.

Exposures: LOS and LOCNC were defined as antibiotic administration for ≥5 days with and without a positive blood/cerebrospinal fluid culture, respectively. Infants with these diagnoses were also compared with infants with neither condition.

Outcomes: Death or NDI was assessed at 18-26 months corrected age follow-up. Modified Poisson regression models were used to estimate relative risks adjusting for covariates occurring ≤7 days of age.

Results: Of 7354 eligible infants, 3940 met inclusion criteria: 786 (20%) with LOS, 1601 (41%) with LOCNC and 1553 (39%) with neither. Infants with LOS had higher adjusted relative risk (95% CI) for death/NDI (1.14 (1.05 to 1.25)) and death before follow-up (1.71 (1.44 to 2.03)) than those with LOCNC. Among survivors, risk for NDI did not differ between the two groups (0.99 (0.86 to 1.13)) but was higher for LOCNC infants (1.17 (1.04 to 1.31)) compared with unaffected infants.

Conclusions: Infants with LOS had higher risk of death, but not NDI, compared with infants with LOCNC. Surviving infants with LOCNC had higher risk of NDI compared with unaffected infants. Improving outcomes for infants with LOCNC requires study of the underlying conditions and the potential impact of antibiotic exposure.
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http://dx.doi.org/10.1136/archdischild-2020-320664DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8292446PMC
September 2021

The General Movements Assessment in Neonates With Hypoxic Ischemic Encephalopathy.

J Child Neurol 2021 07 13;36(8):601-609. Epub 2021 Jan 13.

Division of Neonatology, Children's Hospital of Philadelphia, Philadelphia, PA, USA.

Background: Clinical measures after birth and studies such as electroencephalogram (EEG) and brain imaging do not fully predict neurodevelopmental outcomes of infants with hypoxic-ischemic encephalopathy. Early detection of adverse neurologic outcomes, and cerebral palsy in particular, in high-risk infants is essential for ensuring timely management. The General Movements Assessment is a tool that can be used in the early detection of cerebral palsy in infants with brain injury. The majority of studies on the General Movements Assessment in the late preterm and term population were performed prior to the introduction of therapeutic hypothermia.

Aims: To apply the General Movements Assessment in late preterm and term infants with hypoxic-ischemic encephalopathy (including those who received therapeutic hypothermia), to determine if clinical markers of hypoxic-ischemic encephalopathy predict abnormal General Movements Assessment findings, and to evaluate interrater reliability of the General Movements Assessment in this population. Study design: Pilot prospective cohort study Subjects: We assessed 29 late preterm and full-term infants with mild, moderate, and severe hypoxic-ischemic encephalopathy in Philadelphia, PA.

Results: Most infants' general movements normalized by the fidgety age. Only infants with moderate or severe hypoxic-ischemic encephalopathy had abnormal general movements in both the writhing and the fidgety ages (n = 6). Seizure at any point during the initial hospitalization was the clinical sign most predictive of abnormal general movements in the fidgety age (sensitivity 100%, specificity 55%, positive predictive value 40%, negative predictive value 100%). Interrater reliability was greatest during the fidgety age (κ = 0.67).

Conclusions: Seizures were the clinical predictor most closely associated with abnormal findings on the General Movements Assessment. However, clinical markers of hypoxic-ischemic encephalopathy are not fully predictive of abnormal General Movements Assessment findings. Larger future studies are needed to evaluate the associations between the General Movements Assessment and childhood neurologic outcomes in patients with hypoxic-ischemic encephalopathy who received therapeutic hypothermia.
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http://dx.doi.org/10.1177/0883073820981515DOI Listing
July 2021

Umbilical Cord Milking vs Delayed Cord Clamping and Associations with In-Hospital Outcomes among Extremely Premature Infants.

J Pediatr 2021 05 5;232:87-94.e4. Epub 2021 Jan 5.

Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA; Leonard Davis Institute of Health Economics, The University of Pennsylvania, Philadelphia, PA. Electronic address:

Objective: To compare in-hospital outcomes after umbilical cord milking vs delayed cord clamping among infants <29 weeks of gestation.

Study Design: Multicenter retrospective study of infants born <29 weeks of gestation from 2016 to 2018 without congenital anomalies who received active treatment at delivery and were exposed to umbilical cord milking or delayed cord clamping. The primary outcome was mortality or severe (grade III or IV) intraventricular hemorrhage (IVH) by 36 weeks of postmenstrual age (PMA). Secondary outcomes assessed at 36 weeks of PMA were mortality, severe IVH, any IVH or mortality, and a composite of mortality or major morbidity. Outcomes were assessed using multivariable regression, incorporating mortality risk factors identified a priori, confounders, and center. A prespecified, exploratory analysis evaluated severe IVH in 2 gestational age strata, 22-24 and 25-28 weeks.

Results: Among 1834 infants, 23.6% were exposed to umbilical cord milking and 76.4% to delayed cord clamping. The primary outcome, mortality or severe IVH, occurred in 21.1% of infants: 28.3% exposed to umbilical cord milking and 19.1% exposed to delayed cord clamping, with an aOR that was similar between groups (aOR 1.45, 95% CI 0.93, 2.26). Infants exposed to umbilical cord milking had higher odds of severe IVH (19.8% umbilical cord milking vs 11.8% delayed cord clamping, aOR 1.70 95% CI 1.20, 2.43), as did the 25-28 week stratum (14.8% umbilical cord milking vs 7.4% delayed cord clamping, aOR 1.89 95% CI 1.22, 2.95). Other secondary outcomes were similar between groups.

Conclusions: This analysis of extremely preterm infants suggests that delayed cord clamping is the preferred practice for placental transfusion, as umbilical cord milking exposure was associated with an increase in the adverse outcome of severe IVH.

Trial Registration: ClinicalTrials.gov: NCT00063063.
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http://dx.doi.org/10.1016/j.jpeds.2020.12.072DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8084979PMC
May 2021

Predictive Value of the BSID-II and the Bayley-III for Early School Age Cognitive Function in Very Preterm Infants.

Glob Pediatr Health 2020 20;7:2333794X20973146. Epub 2020 Nov 20.

Children's Hospital of Philadelphia, Philadelphia, PA, USA.

Objective: To compare the predictive validity of the Bayley Scales of Infant Development, Second Edition (BSID-II) and the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) for cognitive function at early school age in very preterm infants.

Methods: Seventy-seven former preterm infants (born <32 weeks gestation and ≤2000 g) completed both the BSID-II and the Bayley-III at 2 years corrected age. Children enrolled at hospitals that perform follow-up beyond 2 years had cognitive assessments with the Wechsler Preschool and Primary Scale of Intelligence Fourth Edition (WPPSI-IV). Associations between Bayley and WPPSI scores were assessed using correlation coefficients, linear regression, and Bland-Altman plots.

Results: Thirty-one of 45 eligible children were tested with the WPPSI-IV at 47 ± 11 months. Average BSID-II Mental Development Index (MDI) was 86 ± 19, Bayley-III Cognitive composite score was 101 ± 12 and WPPSI Full Scale IQ (FSIQ) was 96 ± 12. Correlation between MDI and FSIQ was 0.54 ( < .001); correlation between Bayley-III cognitive composite score and FSIQ was 0.31 ( = .03). Bayley-III language composite had a modestly stronger correlation with FSIQ than cognitive composite (correlation coefficient 0.39;  = .005). Linear regression models also demonstrated that BSID-II was more closely correlated with FSIQ than Bayley-III. This bias was consistent across the full range of scores.

Conclusion: The BSID-II underestimated FSIQ and the Bayley-III overestimated FSIQ. Children at risk for impairment might be missed with the Bayley-III. As the Bayley-4 is introduced, clinicians and researchers should be cautious about interpretation of scores until performance of this new measure is fully understood.
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http://dx.doi.org/10.1177/2333794X20973146DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7683841PMC
November 2020

Cerebral Pulsed Arterial Spin Labeling Perfusion Weighted Imaging Predicts Language and Motor Outcomes in Neonatal Hypoxic-Ischemic Encephalopathy.

Front Pediatr 2020 25;8:576489. Epub 2020 Sep 25.

Children's Hospital of Philadelphia, Philadelphia, PA, United States.

To compare cerebral pulsed arterial spin labeling (PASL) perfusion among controls, hypoxic ischemic encephalopathy (HIE) neonates with normal conventional MRI(HIE/MRI⊕), and HIE neonates with abnormal conventional MRI(HIE/MRI⊖). To create a predictive machine learning model of neurodevelopmental outcomes using cerebral PASL perfusion. A total of 73 full-term neonates were evaluated. The cerebral perfusion values were compared by permutation test to identify brain regions with significant perfusion changes among 18 controls, 40 HIE/MRI⊖ patients, and 15 HIE/MRI⊕ patients. A machine learning model was developed to predict neurodevelopmental outcomes using the averaged perfusion in those identified brain regions. Significantly decreased PASL perfusion in HIE/MRI⊖ group, when compared with controls, were found in the anterior corona radiata, caudate, superior frontal gyrus, precentral gyrus. Both significantly increased and decreased cerebral perfusion changes were detected in HIE/MRI⊕ group, when compared with HIE/MRI⊖ group. There were no significant perfusion differences in the cerebellum, brainstem and deep structures of thalamus, putamen, and globus pallidus among the three groups. The machine learning model demonstrated significant correlation ( < 0.05) in predicting language( = 0.48) and motor( = 0.57) outcomes in HIE/MRI⊖ patients, and predicting language( = 0.76), and motor( = 0.53) outcomes in an additional group combining HIE/MRI⊖ and HIE/MRI⊕. Perfusion MRI can play an essential role in detecting HIE regardless of findings on conventional MRI and predicting language and motor outcomes in HIE survivors. The perfusion changes may also reveal important insights into the reperfusion response and intrinsic autoregulatory mechanisms. Our results suggest that perfusion imaging may be a useful adjunct to conventional MRI in the evaluation of HIE in clinical practice.
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http://dx.doi.org/10.3389/fped.2020.576489DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7546822PMC
September 2020

Survival and Developmental Outcomes of Neonates Treated with Extracorporeal Membrane Oxygenation: A 10-Year Single-Center Experience.

J Pediatr 2021 02 13;229:134-140.e3. Epub 2020 Oct 13.

Division of Neonatology, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA. Electronic address:

Objective: To evaluate the associations between the primary indication for extracorporeal membrane oxygenation (ECMO) in neonates and neurodevelopmental outcomes at 12 and 24 months of age.

Study Design: This is a retrospective cohort study of neonates treated with ECMO between January 2006 and January 2016 in the Children's Hospital of Philadelphia newborn/infant intensive care unit. Primary indication for ECMO was classified as medical (eg, meconium aspiration syndrome) or surgical (eg, congenital diaphragmatic hernia). Primary study endpoints were assessed with the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III). Groups were compared with standard bivariate testing and multivariable regression.

Results: A total of 191 neonates met the study's inclusion criteria, including 96 with a medical indication and 95 with a surgical indication. Survival to discharge was 71%, with significantly higher survival in the medical group (82% vs 60%; P = .001). Survivors had high rates of developmental therapies and neurosensory abnormalities. Developmental outcomes were available for 66% at 12 months and 70% at 24 months. Average performance on the Bayley-III was significantly below expected population normative values. Surgical patients had modestly lower the Bayley-III scores over time; most notably, 15% of medical infants and 49% of surgical infants had motor delay at 24 months (P = .03).

Conclusions: In this single-center cohort, surgical patients had lower survival rates and higher incidence of motor delays. Strategies to reduce barriers to follow-up and improve rates of postdischarge developmental surveillance and intervention in this high-risk population are needed.
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http://dx.doi.org/10.1016/j.jpeds.2020.10.011DOI Listing
February 2021

Recorded Flexible Nasolaryngoscopy for Neonatal Vocal Cord Assessment in a Prospective Cohort.

Ann Otol Rhinol Laryngol 2021 Mar 14;130(3):292-297. Epub 2020 Aug 14.

Division of Otolaryngology, Children's Hospital of Philadelphia, Philadelphia, PA, USA.

Objective: Assessing vocal cord mobility by flexible nasolaryngoscopy (FNL) can be difficult in neonates. To date, prospective studies evaluating the incidence and diagnostic accuracy of vocal cord paralysis (VCP) after surgical patent ductus arteriosus (PDA) ligation are limited. It is unknown whether video FNL improves diagnosis in this population. This study compared video recordings with bedside evaluation for diagnosis of VCP and determined inter-rater reliability of the diagnosis of VCP in preterm infants after PDA ligation.

Methods: Prospective cohort of preterm neonates undergoing bedside FNL within two weeks of extubation following PDA ligation. In a subset, FNL was recorded. Two pediatric otolaryngologists, blinded to the initial diagnosis, reviewed the FNL video recordings.

Results: Eighty infants were enrolled and 37 with a recorded FNL were included in the cohort. Average gestational age at birth was 25.2 weeks (SD: 1.2) and postmenstrual age at FNL was 37.0 weeks (SD: 4.5), which was 9.5 days (SD: 14.7) after extubation following PDA repair. There were 6 diagnosed with left VCP (16.2%; 95% CI: 4.3-28.1%) at bedside, and 9 diagnosed by video review (24.3%; 95% CI: 10.5-38.1%) ( = .56). Videos confirmed all 6 VCP diagnosed initially, but also identified 3 additional cases. Though imperfect, reviewing FNL by video showed substantial reliability (kappa = .75), with 91.9% agreement.

Conclusion: Video recorded FNL most often confirms a bedside diagnosis of VCP, but may also identify discrepancies. Physicians should consider the limitations of diagnosis especially when infants persist with symptoms such as weak voice or signs of postoperative aspiration.

Level Of Evidence: 2b.
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http://dx.doi.org/10.1177/0003489420950370DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7878273PMC
March 2021

Recorded Continuous Oximetry Improves Postdischarge Management of Bronchopulmonary Dysplasia.

Authors:
Sara B DeMauro

Pediatrics 2020 08 14;146(2). Epub 2020 Jul 14.

Children's Hospital of Philadelphia and Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania

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http://dx.doi.org/10.1542/peds.2020-002774DOI Listing
August 2020

Racial/Ethnic Disparities Among Extremely Preterm Infants in the United States From 2002 to 2016.

JAMA Netw Open 2020 06 1;3(6):e206757. Epub 2020 Jun 1.

Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.

Importance: Racial/ethnic disparities in quality of care among extremely preterm infants are associated with adverse outcomes.

Objective: To assess whether racial/ethnic disparities in major outcomes and key care practices were changing over time among extremely preterm infants.

Design, Setting, And Participants: This observational cohort study used prospectively collected data from 25 US academic medical centers. Participants included 20 092 infants of 22 to 27 weeks' gestation with a birth weight of 401 to 1500 g born at centers participating in the National Institute of Child Health and Human Development Neonatal Research Network from 2002 to 2016. Of these infants, 9316 born from 2006 to 2014 were eligible for follow-up at 18 to 26 months' postmenstrual age (excluding 5871 infants born before 2006, 2594 infants born after 2014, and 2311 ineligible infants including 64 with birth weight >1000 g and 2247 infants with gestational age >26 6/7 weeks), of whom 745 (8.0%) did not have known follow-up outcomes at 18 to 26 months.

Main Outcomes And Measures: Rates of mortality, major morbidities, and care practice use over time were evaluated using models adjusted for baseline characteristics, center, and birth year. Data analyses were conducted from 2018 to 2019.

Results: In total, 20 092 infants with a mean (SD) gestational age of 25.1 (1.5) weeks met the inclusion criteria and were available for the primary outcome: 8331 (41.5%) black infants, 3701 (18.4%) Hispanic infants, and 8060 (40.1%) white infants. Hospital mortality decreased over time in all groups. The rate of improvement in hospital mortality over time did not differ among black and Hispanic infants compared with white infants (black infants went from 35% to 24%, Hispanic infants went from 32% to 27%, and white infants went from 30% to 22%; P = .59 for race × year interaction). The rates of late-onset sepsis among black infants (went from 37% to 24%) and Hispanic infants (went from 45% to 23%) were initially higher than for white infants (went from 36% to 25%) but decreased more rapidly and converged during the most recent years (P = .02 for race × year interaction). Changes in rates of other major morbidities did not differ by race/ethnicity. Death before follow-up decreased over time (from 2006 to 2014: black infants, 14%; Hispanic infants, 39%, white infants, 15%), but moderate-severe neurodevelopmental impairment increased over time in all racial/ethnic groups (increase from 2006 to 2014: black infants, 70%; Hispanic infants, 123%; white infants, 130%). Rates of antenatal corticosteroid exposure (black infants went from 72% to 90%, Hispanic infants went from 73% to 83%, and white infants went from 86% to 90%; P = .01 for race × year interaction) and of cesarean delivery (black infants went from 45% to 59%, Hispanic infants went from 49% to 59%, and white infants went from 62% to 63%; P = .03 for race × year interaction) were initially lower among black and Hispanic infants compared with white infants, but these differences decreased over time.

Conclusions And Relevance: Among extremely preterm infants, improvements in adjusted rates of mortality and most major morbidities did not differ by race/ethnicity, but rates of neurodevelopmental impairment increased in all groups. There were narrowing racial/ethnic disparities in important care practices, including the use of antenatal corticosteroids and cesarean delivery.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.6757DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7287569PMC
June 2020

Impact of Early-Onset Sepsis and Antibiotic Use on Death or Survival with Neurodevelopmental Impairment at 2 Years of Age among Extremely Preterm Infants.

J Pediatr 2020 06;221:39-46.e5

Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX.

Objective: To evaluate the hypothesis that early-onset sepsis increases risk of death or neurodevelopmental impairment (NDI) among preterm infants; and that among infants without early-onset sepsis, prolonged early antibiotics alters risk of death/NDI.

Study Design: Retrospective cohort study of infants born at the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network centers (2006-2014) at 22-26 weeks of gestation and birth weight 401-1000 g. Early-onset sepsis defined as growth of a pathogen from blood or cerebrospinal fluid culture ≤72 hours after birth. Prolonged early antibiotics was defined as antibiotics initiated ≤72 hours and continued ≥5 days without culture-confirmed infection, necrotizing enterocolitis, or spontaneous perforation. Primary outcome was death before follow-up or NDI assessed at 18-26 months corrected age. Poisson regression was used to estimate adjusted relative risk (aRR) and CI for early-onset sepsis outcomes. A propensity score for receiving prolonged antibiotics was derived from early clinical factors and used to match infants (1:1) with and without prolonged antibiotic exposure. Log binomial models were used to estimate aRR for outcomes in matched infants.

Results: Among 6565 infants, those with early-onset sepsis had higher aRR (95% CI) for death/NDI compared with infants managed with prolonged antibiotics (1.18 [1.06-1.32]) and to infants without prolonged antibiotics (1.23 [1.10-1.37]). Propensity score matching was achieved for 4362 infants. No significant difference in death/NDI (1.04 [0.98-1.11]) was observed with or without prolonged antibiotics among the matched cohort.

Conclusions: Early-onset sepsis was associated with increased risk of death/NDI among extremely preterm infants. Among matched infants without culture-confirmed infection, prolonged early antibiotic administration was not associated with death/NDI.
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http://dx.doi.org/10.1016/j.jpeds.2020.02.038DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7248124PMC
June 2020

Antenatal Corticosteroids-Too Much of a Good Thing?

Authors:
Sara B DeMauro

JAMA 2020 05;323(19):1910-1912

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.

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http://dx.doi.org/10.1001/jama.2020.3935DOI Listing
May 2020

A Mixed Methods Analysis of Parental Perspectives on Diagnosis and Prognosis of Neonatal Intensive Care Unit Graduates With Cerebral Palsy.

J Child Neurol 2020 04 17;35(5):336-343. Epub 2020 Feb 17.

Department of Communication, Mississippi State University, MS, USA.

This study aimed to evaluate how parents of former neonatal intensive care unit patients with cerebral palsy perceive prognostic discussions following neuroimaging. Parent members of a cerebral palsy support network described memories of prognostic discussions after neuroimaging in the neonatal intensive care unit. We analyzed responses using Linguistic Inquiry and Word Count, manual content analysis, and thematic analysis. In 2015, a total of 463 parents met eligibility criteria and 266 provided free-text responses. Linguistic Inquiry and Word Count analysis showed that responses following neuroimaging contained negative emotion. The most common components identified through the content analysis included outcome, uncertainty, hope/hopelessness, and weakness in communication. Thematic analysis revealed 3 themes: (1) Information, (2) Communication, and (3) Impact. Parents of children with cerebral palsy report weakness in communication relating to prognosis, which persists in parents' memories. Prospective work to develop interventions to improve communication between parents and providers in the neonatal intensive care unit is necessary.
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http://dx.doi.org/10.1177/0883073820901412DOI Listing
April 2020

Timing of postnatal steroids for bronchopulmonary dysplasia: association with pulmonary and neurodevelopmental outcomes.

J Perinatol 2020 04 4;40(4):616-627. Epub 2020 Feb 4.

Department of Pediatrics, The Children's Hospital of Philadelphia and The University of Pennsylvania, Philadelphia, PA, USA.

Objective: To determine the associations between age at first postnatal corticosteroids (PNS) exposure and risk for severe bronchopulmonary dysplasia (BPD) and neurodevelopmental impairment (NDI).

Study Design: Cohort study of 951 infants born <27 weeks gestational age at NICHD Neonatal Research Network sites who received PNS between 8 days of life (DOL) and 36 weeks' postmenstrual age was used to produce adjusted odds ratios (aOR).

Results: Compared with infants in the reference group (22-28 DOL-lowest rate), aOR for severe BPD was similar for children given PNS between DOL 8 and 49 but higher among infants treated at DOL 50-63 (aOR 1.77, 95% CI 1.03-3.06), and at DOL ≥64 (aOR 3.06, 95% CI 1.44-6.48). The aOR for NDI did not vary significantly by age of PNS exposure.

Conclusion: For infants at high risk of BPD, initial PNS should be considered prior to 50 DOL for the lowest associated odds of severe BPD.
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http://dx.doi.org/10.1038/s41372-020-0594-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7101070PMC
April 2020

Behavior Profiles at 2 Years for Children Born Extremely Preterm with Bronchopulmonary Dysplasia.

J Pediatr 2020 04 31;219:152-159.e5. Epub 2020 Jan 31.

Department of Pediatrics, Stanford University, Palo Alto, CA.

Objective: To characterize behavior of 2-year-old children based on the severity of bronchopulmonary dysplasia (BPD).

Study Design: We studied children born at 22-26 weeks of gestation and assessed at 22-26 months of corrected age with the Child Behavior Checklist (CBCL). BPD was classified by the level of respiratory support at 36 weeks of postmenstrual age. CBCL syndrome scales were the primary outcomes. The relationship between BPD grade and behavior was evaluated, adjusting for perinatal confounders. Mediation analysis was performed to evaluate whether cognitive, language, or motor skills mediated the effect of BPD grade on behavior.

Results: Of 2310 children, 1208 (52%) had no BPD, 806 (35%) had grade 1 BPD, 177 (8%) had grade 2 BPD, and 119 (5%) had grade 3 BPD. Withdrawn behavior (P < .001) and pervasive developmental problems (P < .001) increased with worsening BPD grade. Sleep problems (P = .008) and aggressive behavior (P = .023) decreased with worsening BPD grade. Children with grade 3 BPD scored 2 points worse for withdrawn behavior and pervasive developmental problems and 2 points better for externalizing problems, sleep problems, and aggressive behavior than children without BPD. Cognitive, language, and motor skills mediated the effect of BPD grade on the attention problems, emotionally reactive, somatic complaints, and withdrawn CBCL syndrome scales (P values < .05).

Conclusions: BPD grade was associated with increased risk of withdrawn behavior and pervasive developmental problems but with decreased risk of sleep problems and aggressive behavior. The relationship between BPD and behavior is complex. Cognitive, language, and motor skills mediate the effects of BPD grade on some problem behaviors.
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http://dx.doi.org/10.1016/j.jpeds.2019.12.028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7096270PMC
April 2020

Cranial Ultrasound and Minor Motor Abnormalities at 2 Years in Extremely Low Gestational Age Infants.

J Dev Behav Pediatr 2020 05;41(4):308-315

Department of Pediatrics, Stanford University School of Medicine, Stanford, CA.

Objectives: The objectives of this study are to determine whether abnormalities on neonatal cranial ultrasound (CUS) are associated with minor motor abnormalities at 2 years' corrected age (CA) and to assess functional outcomes and resource utilization among children with minor motor abnormalities.

Methods: Infants born at <27 weeks in the National Institute of Child Health and Human Development Neonatal Research Network between January 1, 2010, and December 31, 2014, who underwent neuroimaging with CUS at both <28 days and ≥28 days and were evaluated at 18 to 26 months' CA, were included. Follow-up included Bayley-3, neuromotor examination, Gross Motor Function Classification System (GMFCS) level, and parent questionnaires about special services and resource needs. Children were classified by the most severe motor abnormality at 18 to 26 months' CA as follows: none, minor, or major motor function abnormality. Minor motor abnormalities were defined as any of the following: (1) Bayley-3 motor composite, fine motor score, or gross motor score 1 to 2 SDs below the test normative means; (2) mild abnormalities of axial or extremity motor skills on standardized neuromotor examination; or (3) GMFCS level 1.

Results: A total of 809 (35%) of 2306 children had minor motor function abnormalities alone. This did not increase substantially with CUS findings (no intraventricular hemorrhage [IVH]: 37%, grade I IVH: 32%, grade II IVH: 38%, grade III/IV IVH: 30%, isolated ventriculomegaly: 33%, and cystic periventricular leukomalacia: 24%). The adjusted odds of minor axial and upper extremity function abnormalities and GMFCS level 1 were significantly higher in children with more severe CUS findings. Children with minor motor abnormalities had increased resource utilization and evidence of functional impairment compared with those without motor function abnormalities.

Conclusion: Minor motor abnormalities at 2 years' CA are common and cannot be predicted by neonatal CUS abnormalities alone. Minor motor abnormalities are associated with higher resource utilization and evidence of functional impairment. These findings have important implications for early counseling and follow-up planning for extremely preterm infants.
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http://dx.doi.org/10.1097/DBP.0000000000000758DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7243172PMC
May 2020

Timing of Referral to Early Intervention Services in Infants With Severe Bronchopulmonary Dysplasia.

Clin Pediatr (Phila) 2019 10 6;58(11-12):1224-1231. Epub 2019 Aug 6.

Children's Hospital of Philadelphia, Philadelphia, PA, USA.

This study is a secondary analysis of an observational prospective case series of 50 infants with severe bronchopulmonary dysplasia that describes patient factors associated with the time between initial hospital discharge and referral to early intervention (EI) services. It also evaluates associations between (1) timing of EI referral and reception of EI services and (2) early referral to EI and developmental outcomes at 18 to 36 months corrected age. The results demonstrated that a referral from a neonatologist versus a pediatrician was associated with fewer days between discharge and EI referral. Earlier EI referrals were associated with a shorter time to intake evaluation and service initiation. The Bayley-III (Bayley Scales of Infant and Toddler Development, 3rd Edition) scores at 24 months corrected age (n = 28) were not associated with timing of EI referral. In conclusion, an early referral to EI promoted earlier evaluation and initiation of EI services and should be standard for high-risk infants.
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http://dx.doi.org/10.1177/0009922819867460DOI Listing
October 2019

Neurodevelopmental Outcomes of Preterm Infants With Retinopathy of Prematurity by Treatment.

Pediatrics 2019 08 23;144(2). Epub 2019 Jul 23.

Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.

Objective: Among extremely preterm infants, we evaluated whether bevacizumab therapy compared with surgery for retinopathy of prematurity (ROP) is associated with adverse outcomes in early childhood.

Methods: This study was a retrospective analysis of prospectively collected data on preterm (22-26 + 6/7 weeks' gestational age) infants admitted to the National Institute of Child Health and Human Development Neonatal Research Network centers who received bevacizumab or surgery exclusively for ROP. The primary outcome was death or severe neurodevelopmental impairment (NDI) at 18 to 26 months' corrected age (Bayley Scales of Infant and Toddler Development, Third Edition cognitive or motor composite score <70, Gross Motor Functional Classification Scale level ≥2, bilateral blindness or hearing impairment).

Results: The cohort ( = 405; 214 [53%] boys; median [interquartile range] gestational age: 24.6 [23.9-25.3] weeks) included 181 (45%) infants who received bevacizumab and 224 (55%) who underwent ROP surgery. Infants treated with bevacizumab had a lower median (interquartile range) birth weight (640 [541-709] vs 660 [572.5-750] g; = .02) and longer durations of conventional ventilation (35 [21-58] vs 33 [18-49] days; = .04) and supplemental oxygen (112 [94-120] vs 105 [84.5-120] days; = .01). Death or severe NDI (adjusted odds ratio [aOR] 1.42; 95% confidence interval [CI] 0.94 to 2.14) and severe NDI (aOR 1.14; 95% CI 0.76 to 1.70) did not differ between groups. Odds of death (aOR 2.54 [95% CI 1.42 to 4.55]; = .002), a cognitive score <85 (aOR 1.78 [95% CI 1.09 to 2.91]; = .02), and a Gross Motor Functional Classification Scale level ≥2 (aOR 1.73 [95% CI 1.04 to 2.88]; = .04) were significantly higher with bevacizumab therapy.

Conclusions: In this multicenter cohort of preterm infants, ROP treatment modality was not associated with differences in death or NDI, but the bevacizumab group had higher mortality and poor cognitive outcomes in early childhood. These data reveal the need for a rigorous appraisal of ROP therapy.
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http://dx.doi.org/10.1542/peds.2018-3537DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6855825PMC
August 2019

Inadequate oral feeding as a barrier to discharge in moderately preterm infants.

J Perinatol 2019 09 11;39(9):1219-1228. Epub 2019 Jul 11.

Department of Pediatrics, Duke University, Durham, NC, 27708, USA.

Objectives: The objectives describe the frequency that inadequate oral feeding (IOF) is the reason why moderately preterm (MPT) infants remain hospitalized and its association with neonatal morbidities.

Study Design: Prospective study using the NICHD Neonatal Research Network MPT Registry. Multivariable logistic regression was used to describe associations between IOF and continued hospitalization at 36 weeks postmenstrual age (PMA).

Result: A total of 6017 MPT infants from 18 centers were included. Three-thousand three-seventy-six (56%) remained hospitalized at 36 weeks PMA, of whom 1262 (37%) remained hospitalized due to IOF. IOF was associated with RDS (OR 2.02, 1.66-2.46), PDA (OR 1.86, 1.37-2.52), sepsis (OR 2.36, 95% 1.48-3.78), NEC (OR 16.14, 7.27-35.90), and BPD (OR 3.65, 2.56-5.21) compared to infants discharged and was associated with medical NEC (OR 2.06, 1.19-3.56) and BPD (OR 0.46, 0.34-0.61) compared to infants remaining hospitalized for an alternative reason.

Conclusion: IOF is the most common barrier to discharge in MPT infants, especially among those with neonatal morbidities.
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http://dx.doi.org/10.1038/s41372-019-0422-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7246972PMC
September 2019

The Diagnosis of Bronchopulmonary Dysplasia in Very Preterm Infants. An Evidence-based Approach.

Am J Respir Crit Care Med 2019 09;200(6):751-759

Division of Neonatology, Department of Pediatrics, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, Pennsylvania.

Current diagnostic criteria for bronchopulmonary dysplasia rely heavily on the level and duration of oxygen therapy, do not reflect contemporary neonatal care, and do not adequately predict childhood morbidity. To determine which of 18 prespecified, revised definitions of bronchopulmonary dysplasia that variably define disease severity according to the level of respiratory support and supplemental oxygen administered at 36 weeks' postmenstrual age best predicts death or serious respiratory morbidity through 18-26 months' corrected age. We assessed infants born at less than 32 weeks of gestation between 2011 and 2015 at 18 centers of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Of 2,677 infants, 683 (26%) died or developed serious respiratory morbidity. The diagnostic criteria that best predicted this outcome defined bronchopulmonary dysplasia according to treatment with the following support at 36 weeks' postmenstrual age, regardless of prior or current oxygen therapy: no bronchopulmonary dysplasia, no support ( = 773); grade 1, nasal cannula ≤2 L/min ( = 1,038); grade 2, nasal cannula >2 L/min or noninvasive positive airway pressure ( = 617); and grade 3, invasive mechanical ventilation ( = 249). These criteria correctly predicted death or serious respiratory morbidity in 81% of study infants. Rates of this outcome increased stepwise from 10% among infants without bronchopulmonary dysplasia to 77% among those with grade 3 disease. A similar gradient (33-79%) was observed for death or neurodevelopmental impairment. The definition of bronchopulmonary dysplasia that best predicted early childhood morbidity categorized disease severity according to the mode of respiratory support administered at 36 weeks' postmenstrual age, regardless of supplemental oxygen use.
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http://dx.doi.org/10.1164/rccm.201812-2348OCDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6775872PMC
September 2019

Home Oxygen and 2-Year Outcomes of Preterm Infants With Bronchopulmonary Dysplasia.

Pediatrics 2019 05 11;143(5). Epub 2019 Apr 11.

Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania and Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.

Objectives: To compare medical and developmental outcomes over the first 2 years of life in extremely preterm infants with bronchopulmonary dysplasia (BPD) who were discharged on supplemental oxygen via nasal cannula with outcomes of infants with a similar severity of respiratory illness who were discharged breathing in room air.

Methods: We performed a propensity score-matched cohort study. Eligible infants were born at <27 weeks' gestation, were receiving supplemental oxygen or respiratory support at 36 weeks' postmenstrual age, and were assessed at 18 to 26 months' corrected age. Study outcomes included growth, resource use, and neurodevelopment between discharge and follow-up. Outcomes were compared by using multivariable models adjusted for center and age at follow-up.

Results: A total of 1039 infants discharged on supplemental oxygen were propensity score matched 1:1 to infants discharged breathing in room air. Infants on oxygen had a marginal improvement in weight score (adjusted mean difference 0.11; 95% confidence interval [CI] 0.00 to 0.22), with a significantly improved weight-for-length score (adjusted mean difference 0.13; 95% CI 0.06 to 0.20) at 22 to 26 months' corrected age. Infants on oxygen were more likely to be rehospitalized for respiratory illness (adjusted relative risk 1.33; 95% CI 1.16 to 1.53) and more likely to use respiratory medications and equipment. Rates of neurodevelopmental impairment were similar between the groups.

Conclusions: In this matched cohort of infants with BPD, postdischarge oxygen was associated with marginally improved growth and increased resource use but no difference in neurodevelopmental outcomes. Ongoing and future trials are critical to assess the efficacy and safety of postdischarge supplemental oxygen for infants with BPD.
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http://dx.doi.org/10.1542/peds.2018-2956DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6564066PMC
May 2019

Association between Policy Changes for Oxygen Saturation Alarm Settings and Neonatal Morbidity and Mortality in Infants Born Very Preterm.

J Pediatr 2019 06 5;209:17-22.e2. Epub 2019 Apr 5.

Division of Neonatology, Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.

Objective: To determine the impact of policy changes for pulse oximetry oxygen saturation (SpO) alarm limits on neonatal mortality and morbidity among infants born very preterm.

Study Design: This was a retrospective cohort study of infants born very preterm in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Infants were classified based on treatment at a hospital with an SpO alarm policy change and study epoch (before vs after policy change). We used a generalized linear mixed model to determine the effect of hospital group and epoch on the primary outcomes of mortality and severe retinopathy of prematurity (ROP) and secondary outcomes of necrotizing enterocolitis, bronchopulmonary dysplasia, and any ROP.

Results: There were 3809 infants in 10 hospitals with an SpO alarm policy change and 3685 infants in 9 hospitals without a policy change. The nature of most policy changes was to narrow the SpO alarm settings. Mortality was lower in hospitals without a policy change (aOR 0.63; 95% CI 0.50-0.80) but did not differ between epochs in policy change hospitals. The odds of bronchopulmonary dysplasia were greater for hospitals with a policy change (aOR 1.65; 95% CI 1.36-2.00) but did not differ for hospitals without a policy change. Severe ROP and necrotizing enterocolitis did not differ between epochs for either group. The adjusted odds of any ROP were lower in recent years in both hospital groups.

Conclusions: Changing SpO alarm policies was not associated with reduced mortality or increased severe ROP among infants born very preterm.
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http://dx.doi.org/10.1016/j.jpeds.2019.01.048DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6535348PMC
June 2019
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