Publications by authors named "Michael D Cabana"

204 Publications

Adherence rates during a randomized controlled trial evaluating the use of blinded acetaminophen and ibuprofen in children with asthma.

Contemp Clin Trials 2021 Feb 27:106334. Epub 2021 Feb 27.

Boston Children's Hospital, Division of Allergy and Immunology, Harvard Medical School, Boston, MA, United States of America. Electronic address:

Background/aims: When conducting clinical trials comparing over-the-counter (OTC) medications, the wide availability of these treatments are a potential challenge to maintaining study integrity. We seek to describe adherence to a study protocol involving widely available OTC medications.

Methods: To prospectively evaluate associations between acetaminophen use and asthma in 300 children aged 1-5 years, we conducted a double blind, randomized, controlled trial where parents administered blinded forms of either acetaminophen or ibuprofen as needed to their children over a 48 week period. Written and verbal instructions encouraged the exclusive use of the blinded study medication and discouraged OTC use. Adherence was determined by evaluating the frequency of use of per-protocol blinded study medication compared to off-protocol use of OTC medications.

Results: 4195 doses of acetaminophen or ibuprofen were received by children during the study which included 3664 doses (87.3%) of blinded study medication adhering to the protocol and 531 doses (12.7%) of OTC products deviating from the protocol with better adherence among those randomized to ibuprofen as compared to acetaminophen (89.5% vs. 85.5% of doses, p < 0.01). Individually, 227 participants (75.7%) remained fully adherent by not receiving any OTC medications. Pre-study preference for either acetaminophen or ibuprofen by the participants' families was not associated with differential rates of adherence to the blinded medication.

Conclusion: This parallel study demonstrated greater than 85% of acetaminophen or ibuprofen doses were blinded study medications adhering to the protocol while less than 15% were OTC deviations from the protocol. This successfully implemented study design provides a template to comparatively evaluate these and other OTC medications.
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http://dx.doi.org/10.1016/j.cct.2021.106334DOI Listing
February 2021

Efficient Clinical Counseling for Sickle Cell Disease.

J Natl Med Assoc 2021 Feb 17. Epub 2021 Feb 17.

Department of Pediatrics, Children's Hospital at Montefiore and the Albert Einstein College of Medicine, Bronx, NY, USA. Electronic address:

Sickle cell anemia (SCA) is a chronic illness that requires frequent health care visits for preventative management. Adherence to national guidelines such as the National Heart Lung and Blood Institute (NHLBI) Expert Panel Report on the Evidence-Based Management of Sickle Cell Disease can be challenging to both the clinician and the patient. Utilizing effective communication strategies with patients and their families can improve clinician/patient relationships, as well as adherence to national guidelines. Aims of this overview are to review challenges faced in outpatient subspecialty medicine and describe evidence-based techniques for more effective communication for patients with sickle cell anemia.
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http://dx.doi.org/10.1016/j.jnma.2021.01.006DOI Listing
February 2021

50 Years Ago in TheJournalofPediatrics: From Aspirin to Magnets: 50 Years of Pediatric Ingestions.

J Pediatr 2021 Feb;229:77

Department of Pediatrics, Children's Hospital at Montefiore & the Albert Einstein School of Medicine, Bronx, New York.

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http://dx.doi.org/10.1016/j.jpeds.2020.08.077DOI Listing
February 2021

Sustainability of paediatric asthma care quality in community hospitals after ending a national quality improvement collaborative.

BMJ Qual Saf 2021 Jan 19. Epub 2021 Jan 19.

Department of Pediatrics, University of California San Francisco, San Francisco, California, USA.

Background: Community hospitals, which care for most hospitalised children in the USA, may be vulnerable to declines in paediatric care quality when quality improvement (QI) initiatives end. We aimed to evaluate changes in care quality in community hospitals after the end of the Pathways for Improving Paediatric Asthma Care (PIPA) national QI collaborative.

Methods: We conducted a longitudinal cohort study during and after PIPA. PIPA included 45 community hospitals, of which 34 completed the 12-month collaborative and were invited for extended sustainability monitoring (total of 21-24 months from collaborative start). PIPA provided paediatric asthma pathways, educational materials/seminars, QI mentorship, monthly data reports, a mobile application and peer-to-peer learning opportunities. Access to pathways, educational materials and the mobile application remained during sustainability monitoring. Charts were reviewed for children aged 2-17 years old hospitalised with a primary diagnosis of asthma (maximum 20 monthly per hospital). Outcomes included measures of guideline adherence (early bronchodilator administration via metered-dose inhaler (MDI), secondhand smoke screening and referral to smoking cessation resources) and length of stay (LOS). We evaluated outcomes using multilevel regression models adjusted for patient mix, using an interrupted time-series approach.

Results: We analysed 2159 hospitalisations from 23 hospitals (68% of eligible). Participating hospitals were structurally similar to those that dropped out but had more improvement in guideline adherence during the collaborative (29% vs 15%, p=0.02). The end of the collaborative was associated with a significant initial decrease in early MDI administration (81%-68%) (adjusted OR (aOR) 0.26 (95% CI 0.15 to 0.42)) and decreased rate of referral to smoking cessation resources (2.2% per month increase to 0.3% per month decrease) (aOR 0.86 (95% CI 0.75 to 0.98)) but no significant changes in LOS or secondhand smoke screening.

Conclusions: The end of a paediatric asthma QI collaborative was associated with concerning declines in guideline adherence in community hospitals.
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http://dx.doi.org/10.1136/bmjqs-2020-012292DOI Listing
January 2021

Improving Preventive Care for Children With Sickle Cell Anemia: A Quality Improvement Initiative.

Pediatr Qual Saf 2021 Jan-Feb;6(1):e379. Epub 2020 Dec 28.

Department of Pediatrics, University of California, San Francisco (UCSF), San Francisco, Calif.

Sickle cell disease is a complex chronic disorder associated with increased morbidity and early mortality. The Pediatric Quality Measures Program has developed new sickle cell-specific quality measures focused on hydroxyurea (HU) counseling and annual transcranial Doppler (TCD) screening; however, these measures have not been used in a clinical setting to inform quality improvement (QI) efforts.

Methods: From 2017 to 2018, 9 sickle cell subspecialty clinics from the Pacific Sickle Cell Regional Collaborative conducted a year-long QI collaborative focused on improving the percentage of patients with HU counseling and TCD screening based on the new quality measures. After an initial kick-off meeting, the 9 sites participated in monthly conference calls. We used run charts annotated with plan-do-study-act cycle activities to track each site's monthly progress and the overall mean percentage for the entire collaborative.

Results: There was an overall improvement in the aggregate HU counseling from 85% to 98% ( < 0.01). For TCD screening, referral frequency changed from 85% to 90% ( = 0.76). For both measures, the variation in frequencies decreased over the year.

Conclusion: Over 1 year, we found that a regional QI collaborative increased HU counseling. Although referral for TCD screening increased, there was no overall change in TCD completion. Overall, this QI report's findings can help clinicians adopt and implement these quality measures to improve outcomes in children.
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http://dx.doi.org/10.1097/pq9.0000000000000379DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7781296PMC
December 2020

A cluster-randomized controlled trial of an elementary school drinking water access and promotion intervention: Rationale, study design, and protocol.

Contemp Clin Trials 2020 Dec 25;101:106255. Epub 2020 Dec 25.

Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, USA; Department of Pediatrics, School of Medicine, Stanford University, USA. Electronic address:

Introduction: Promoting water consumption among children in schools is a promising intervention to reduce sugar-sweetened beverage (SSB) intake and achieve healthful weight. To date, no studies in the United States have examined how a school-based water access and promotion intervention affects students' beverage and food intake both in and out of school and weight gain over time. The Water First trial is intended to evaluate these interventions.

Methods: Informed by the PRECEDE-PROCEED model and Social Cognitive Theory, the Water First intervention includes: 1) installation of lead-free water stations in cafeterias, physical activity spaces, and high-traffic common areas in lower-income public elementary schools, 2) provision of cups/reusable water bottles for students, and 3) a 6-month healthy beverage education campaign. A five year-long cluster randomized controlled trial of 26 low-income public elementary schools in the San Francisco Bay Area is examining how Water First impacts students' consumption of water, caloric intake from foods and beverages, and BMI z-score and overweight/obesity prevalence, from baseline to 7 months and 15 months after the start of the study. Intervention impact on outcomes will be examined using a difference-in-differences approach with mixed-effects regression accounting for the clustering of students in schools and classrooms.

Discussion: This paper describes the rationale, study design, and protocol for the Water First study. If the intervention is effective, findings will inform best practices for implementing school water policies, as well as the development of more expansive policies and programs to promote and improve access to drinking water in schools.
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http://dx.doi.org/10.1016/j.cct.2020.106255DOI Listing
December 2020

Perspectives from the Society for Pediatric Research: Probiotic use in urinary tract infections, atopic dermatitis, and antibiotic-associated diarrhea: an overview.

Pediatr Res 2020 Dec 7. Epub 2020 Dec 7.

Department of Pediatrics, Children's Hospital at Montefiore and the Albert Einstein School of Medicine, Bronx, NY, USA.

Probiotics have received significant attention within both the scientific and lay communities for their potential health-promoting properties, including the treatment or prevention of various conditions in children. In this article, we review the published data on use of specific probiotic strains for three common pediatric conditions: the prevention of urinary tract infections and antibiotic-associated diarrhea and the treatment of atopic dermatitis. Research into the utility of specific probiotic strains is of varying quality, and data are often derived from small studies and case series. We discuss the scientific merit of these studies, their overall findings regarding the utility of probiotics for these indications, issues in reporting of methods, and results from these clinical trials, as well as future areas of investigation.
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http://dx.doi.org/10.1038/s41390-020-01298-1DOI Listing
December 2020

Statewide Asthma Learning Collaborative Participation and Asthma-Related Emergency Department Use.

Pediatrics 2020 12;146(6)

Pediatrics, School of Medicine, University of California San Francisco, San Francisco, California; and.

Background: Quality improvement (QI) efforts can improve guideline-recommended asthma care processes in the pediatric office setting. We sought to assess whether practice participation in an asthma QI collaborative was associated with decreased asthma-related emergency department (ED) visits.

Methods: A statewide network of practices participated in a pediatric asthma QI collaborative from 2015 to 2016. We evaluated asthma-related ED visit rates per 100 child-years for children ages 3 to 21 years with asthma, using the state's all-payer claims database. We used a difference-in-differences approach, with mixed-effects negative binomial regression models to control for practice and patient covariates. Our main analysis measured the outcome before (2014) and after (2017) the QI collaborative at fully participating and control practices. Additional analyses assessed (1) associations during the intervention period (2016) and (2) associations including practices partially participating in QI collaborative activities.

Results: In the postintervention year (2017), participating practices' ( = 20) asthma-related ED visit rate decreased by 5.8 per 100 child-years, compared to an increase of 1.8 per 100 child-years for control practices ( = 15; difference in differences = -7.3; = .002). Within the intervention year (2016), we found no statistically significant differences in asthma-related ED visit rates compared to controls (difference in differences = -4.3; = .17). The analysis including partially participating practices yielded similar results and inferences to our main analysis.

Conclusions: Participation in an asthma-focused QI collaborative was associated with decreased asthma-related ED visit rates. For those considering implementing this type of QI collaborative, our findings indicate that it takes time to see measurable improvements in ED visit rates. Further study is warranted regarding QI elements contributing to success for partial participants.
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http://dx.doi.org/10.1542/peds.2020-0213DOI Listing
December 2020

Severe Acute Respiratory Syndrome Coronavirus 2 Clinical Syndromes and Predictors of Disease Severity in Hospitalized Children and Youth.

J Pediatr 2021 03 14;230:23-31.e10. Epub 2020 Nov 14.

Department of Pediatrics, Albert Einstein College of Medicine, Children's Hospital at Montefiore, Bronx, NY.

Objective: To characterize the demographic and clinical features of pediatric severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) syndromes and identify admission variables predictive of disease severity.

Study Design: We conducted a multicenter, retrospective, and prospective study of pediatric patients hospitalized with acute SARS-CoV-2 infections and multisystem inflammatory syndrome in children (MIS-C) at 8 sites in New York, New Jersey, and Connecticut.

Results: We identified 281 hospitalized patients with SARS-CoV-2 infections and divided them into 3 groups based on clinical features. Overall, 143 (51%) had respiratory disease, 69 (25%) had MIS-C, and 69 (25%) had other manifestations including gastrointestinal illness or fever. Patients with MIS-C were more likely to identify as non-Hispanic black compared with patients with respiratory disease (35% vs 18%, P = .02). Seven patients (2%) died and 114 (41%) were admitted to the intensive care unit. In multivariable analyses, obesity (OR 3.39, 95% CI 1.26-9.10, P = .02) and hypoxia on admission (OR 4.01; 95% CI 1.14-14.15; P = .03) were predictive of severe respiratory disease. Lower absolute lymphocyte count (OR 8.33 per unit decrease in 10 cells/L, 95% CI 2.32-33.33, P = .001) and greater C-reactive protein (OR 1.06 per unit increase in mg/dL, 95% CI 1.01-1.12, P = .017) were predictive of severe MIS-C. Race/ethnicity or socioeconomic status were not predictive of disease severity.

Conclusions: We identified variables at the time of hospitalization that may help predict the development of severe SARS-CoV-2 disease manifestations in children and youth. These variables may have implications for future prognostic tools that inform hospital admission and clinical management.
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http://dx.doi.org/10.1016/j.jpeds.2020.11.016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7666535PMC
March 2021

Newborn Daily Crying Time Duration.

J Pediatr Nurs 2021 Jan-Feb;56:35-37. Epub 2020 Nov 9.

Department of Neurology, University of California San Francisco (UCSF), USA.

Purpose: Current methods for estimating infant crying time are potentially subject to error as they rely on parents to contemporaneously log and calculate crying time. Our aim was to present the average daily infant crying times from a digital recording device, not dependent on parent-based measurement.

Design And Methods: We conducted a descriptive longitudinal survey of infant crying times. Parents of healthy, term newborns were provided with voice-activated digital recording devices and asked to record infants continuously for randomly selected 24-hour periods during a 4 week time period. We analyzed the daily crying time for infants at different weeks of life.

Results: Of 136 families approached, 28 (20.5%) families were consented with 3 families withdrawing and 5 families submitting incomplete datasets, leaving a total of 20 families with complete datasets. During the first week of life, the mean crying time was about 25 minutes/day, which remained stable for the next few weeks until five weeks of life, when mean crying time increased to almost 40 minutes/day with increasing variance.

Conclusions: In our study sample, infant mean daily crying times based on objective data were much less than estimates in recent studies.

Practice Implications: This study suggests daily crying times measured by digital recorders are less than daily crying times based on parent diaries published in the literature. With the development of new 'apps' to record duration times, it may be clinically inappropriate to compare data based on digital recorders with norms from studies that use parent-reported crying times.
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http://dx.doi.org/10.1016/j.pedn.2020.10.003DOI Listing
November 2020

Defining pediatric asthma: phenotypes to endotypes and beyond.

Pediatr Res 2020 Nov 10. Epub 2020 Nov 10.

Department of Pediatrics and Genomics and Precision Medicine, George Washington University School of Medicine and Health Sciences, Washington, DC, USA.

Asthma is the most common chronic pediatric lung disease that has traditionally been defined as a syndrome of airway inflammation characterized by clinical symptoms of cough and wheeze. Highlighting the complex and heterogeneous nature of asthma, this review summarizes recent advances in asthma classification that are based on pathobiology, and thereby directly addresses limitations of existent definitions of asthma. By reviewing and contrasting clinical and mechanistic features of adult and childhood asthma, the review summarizes key biomarkers that distinguish childhood asthma subtypes. While atopy and its severity are important features of childhood asthma, there is evidence to support the existence of a childhood asthma endotype distinct from the atopic endotype. Although biomarkers of non-atopic asthma are an area of future research, we summarize a clinical approach that includes existing measures of airway-specific and systemic measures of atopy, co-existing morbidities, and disease severity and control, in the definition of childhood asthma, to empower health care providers to better characterize asthma disease burden in children. Identification of biomarkers of non-atopic asthma and the contribution of genetics and epigenetics to pediatric asthma burden remains a research need, which can potentially allow delivery of precision medicine to pediatric asthma. IMPACT: This review highlights asthma as a complex and heterogeneous disease and discusses recent advances in the understanding of the pathobiology of asthma to demonstrate the need for a more nuanced definitions of asthma. We review current knowledge of asthma phenotypes and endotypes and put forth an approach to endotyping asthma that may be useful for defining asthma for clinical care as well as for future research studies in the realm of personalized medicine for asthma.
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http://dx.doi.org/10.1038/s41390-020-01231-6DOI Listing
November 2020

Prenatal and Childhood Tobacco Smoke Exposure Are Associated With Sleep-Disordered Breathing Throughout Early Childhood.

Acad Pediatr 2020 Nov 5. Epub 2020 Nov 5.

Department of Dermatology, Program for Clinical Research, University of California, San Francisco (K Abuabara).

Objective: To determine whether prenatal and childhood tobacco smoke exposure (TSE) are each independently associated with mild sleep-disordered breathing (SDB) symptoms throughout early childhood, and whether the association between childhood TSE and SDB differs according to the level of prenatal exposure.

Methods: Longitudinal cohort study, using data from the Avon Longitudinal Study of Parents and Children, a population-based birth cohort from the United Kingdom. Primary exposures were repeated measures of mother-reported prenatal and childhood TSE through age 7 years. Outcomes were mother-reported measures of mild SDB symptoms, including snoring, mouth breathing, and witnessed apnea, repeated annually through age 7 years.

Results: A total of 12,030 children were followed for a median duration of 7 years. About 24.2% were exposed to prenatal tobacco smoke, 46.2% were exposed at least once in childhood, and 20.6% were exposed during both periods. Both prenatal and childhood TSE were associated with SDB symptoms throughout early childhood (adjusted OR [aOR] for any prenatal TSE 1.23; 95% confidence interval [CI] 1.08, 1.40; aOR for any childhood TSE 1.17; 95% CI 1.06, 1.29). We observed a dose-response effect between TSE and SBD symptoms, and found evidence of effect modification for those exposed during both time periods (combined high level exposure both prenatally and during childhood: aOR snoring 2.43 [95% CI 1.50, 3.93], aOR apnea 2.65 [95% CI 1.46, 4.82]).

Conclusions: Prenatal and childhood TSE were both independently associated with mild SDB symptoms throughout early childhood in a dose-dependent manner, further supporting the critical importance of maintaining a tobacco-free environment throughout gestation and childhood.
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http://dx.doi.org/10.1016/j.acap.2020.11.003DOI Listing
November 2020

Effectiveness of Pediatric Asthma Pathways in Community Hospitals: A Multisite Quality Improvement Study.

Pediatr Qual Saf 2020 Nov-Dec;5(6):e355. Epub 2020 Oct 26.

Department of Pediatrics, University of California, San Francisco, California.

Pathways guide clinicians through evidence-based care of specific conditions. Pathways have been demonstrated to improve pediatric asthma care, but mainly in studies at tertiary children's hospitals. Our global aim was to enhance the quality of asthma care across multiple measures by implementing pathways in community hospitals.

Methods: This quality improvement study included children ages 2-17 years with a primary diagnosis of asthma. Data were collected before and after pathway implementation (total 28 mo). Pathway implementation involved local champions, educational meetings, audit/feedback, and electronic health record integration. Emergency department (ED) measures included severity assessment at triage, timely systemic corticosteroid administration (within 60 mins), chest radiograph (CXR) utilization, hospital admission, and length of stay (LOS). Inpatient measures included screening for secondhand tobacco and referral to cessation resources, early administration of bronchodilator via metered-dose inhaler, antibiotic prescription, LOS, and 7-day readmission/ED revisit. Analyses were done using statistical process control.

Results: We analyzed 881 ED visits and 138 hospitalizations from 2 community hospitals. Pathways were associated with increases in the proportion of children with timely systemic corticosteroid administration (Site 1: 32%-57%, Site 2: 62%-75%) and screening for secondhand tobacco (Site 1: 82%-100%, Site 2: 54%-89%); and decreases in CXR utilization (Site 1: 44%-29%), ED LOS (Site 1: 230-197 mins), and antibiotic prescription (Site 2: 23%-3%). There were no significant changes in other outcomes.

Conclusions: Pathways improved pediatric asthma care quality in the ED and inpatient settings of community hospitals.
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http://dx.doi.org/10.1097/pq9.0000000000000355DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7591126PMC
October 2020

Effect of Vitamin D3 Supplementation on Severe Asthma Exacerbations in Children With Asthma and Low Vitamin D Levels: The VDKA Randomized Clinical Trial.

JAMA 2020 08;324(8):752-760

Division of Pulmonary Medicine, Department of Pediatrics, University of Pittsburgh Medical Center Children's Hospital of Pittsburgh, University of Pittsburgh, Pittsburgh, Pennsylvania.

Importance: Severe asthma exacerbations cause significant morbidity and costs. Whether vitamin D3 supplementation reduces severe childhood asthma exacerbations is unclear.

Objective: To determine whether vitamin D3 supplementation improves the time to a severe exacerbation in children with asthma and low vitamin D levels.

Design, Setting, And Participants: The Vitamin D to Prevent Severe Asthma Exacerbations (VDKA) Study was a randomized, double-blind, placebo-controlled clinical trial of vitamin D3 supplementation to improve the time to severe exacerbations in high-risk children with asthma aged 6 to 16 years taking low-dose inhaled corticosteroids and with serum 25-hydroxyvitamin D levels less than 30 ng/mL. Participants were recruited from 7 US centers. Enrollment started in February 2016, with a goal of 400 participants; the trial was terminated early (March 2019) due to futility, and follow-up ended in September 2019.

Interventions: Participants were randomized to vitamin D3, 4000 IU/d (n = 96), or placebo (n = 96) for 48 weeks and maintained with fluticasone propionate, 176 μg/d (6-11 years old), or 220 μg/d (12-16 years old).

Main Outcomes And Measures: The primary outcome was the time to a severe asthma exacerbation. Secondary outcomes included the time to a viral-induced severe exacerbation, the proportion of participants in whom the dose of inhaled corticosteroid was reduced halfway through the trial, and the cumulative fluticasone dose during the trial.

Results: Among 192 randomized participants (mean age, 9.8 years; 77 girls [40%]), 180 (93.8%) completed the trial. A total of 36 participants (37.5%) in the vitamin D3 group and 33 (34.4%) in the placebo group had 1 or more severe exacerbations. Compared with placebo, vitamin D3 supplementation did not significantly improve the time to a severe exacerbation: the mean time to exacerbation was 240 days in the vitamin D3 group vs 253 days in the placebo group (mean group difference, -13.1 days [95% CI, -42.6 to 16.4]; adjusted hazard ratio, 1.13 [95% CI, 0.69 to 1.85]; P = .63). Vitamin D3 supplementation, compared with placebo, likewise did not significantly improve the time to a viral-induced severe exacerbation, the proportion of participants whose dose of inhaled corticosteroid was reduced, or the cumulative fluticasone dose during the trial. Serious adverse events were similar in both groups (vitamin D3 group, n = 11; placebo group, n = 9).

Conclusions And Relevance: Among children with persistent asthma and low vitamin D levels, vitamin D3 supplementation, compared with placebo, did not significantly improve the time to a severe asthma exacerbation. The findings do not support the use of vitamin D3 supplementation to prevent severe asthma exacerbations in this group of patients.

Trial Registration: ClinicalTrials.gov Identifier: NCT02687815.
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http://dx.doi.org/10.1001/jama.2020.12384DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7448830PMC
August 2020

Clinical Characteristics and Outcomes of Hospitalized and Critically Ill Children and Adolescents with Coronavirus Disease 2019 at a Tertiary Care Medical Center in New York City.

J Pediatr 2020 08 11;223:14-19.e2. Epub 2020 May 11.

Division of Critical Care Medicine, Department of Pediatrics, Albert Einstein College of Medicine, Children's Hospital at Montefiore, Bronx, NY; Division of Cardiology, Department of Pediatrics, Albert Einstein College of Medicine, Children's Hospital at Montefiore, Bronx, NY. Electronic address:

Objective: To describe the clinical profiles and risk factors for critical illness in hospitalized children and adolescents with coronavirus disease 2019 (COVID-19).

Study Design: Children 1 month to 21 years of age with COVID-19 from a single tertiary care children's hospital between March 15 and April 13, 2020 were included. Demographic and clinical data were collected.

Results: In total, 67 children tested positive for COVID-19; 21 (31.3%) were managed as outpatients. Of 46 admitted patients, 33 (72%) were admitted to the general pediatric medical unit and 13 (28%) to the pediatric intensive care unit (PICU). Obesity and asthma were highly prevalent but not significantly associated with PICU admission (P = .99). Admission to the PICU was significantly associated with higher C-reactive protein, procalcitonin, and pro-B type natriuretic peptide levels and platelet counts (P < .05 for all). Patients in the PICU were more likely to require high-flow nasal cannula (P = .0001) and were more likely to have received Remdesivir through compassionate release (P < .05). Severe sepsis and septic shock syndromes were observed in 7 (53.8%) patients in the PICU. Acute respiratory distress syndrome was observed in 10 (77%) PICU patients, 6 of whom (46.2%) required invasive mechanical ventilation for a median of 9 days. Of the 13 patients in the PICU, 8 (61.5%) were discharged home, and 4 (30.7%) patients remain hospitalized on ventilatory support at day 14. One patient died after withdrawal of life-sustaining therapy because of metastatic cancer.

Conclusions: We describe a higher than previously recognized rate of severe disease requiring PICU admission in pediatric patients admitted to the hospital with COVID-19.
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http://dx.doi.org/10.1016/j.jpeds.2020.05.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7212947PMC
August 2020

Addressing Faculty Emotional Responses during the Coronavirus 2019 Pandemic.

J Pediatr 2020 07 7;222:13-14. Epub 2020 May 7.

Department of Pediatrics, Albert Einstein College of Medicine, Bronx, NY; Children's Hospital at Montefiore, Bronx, NY.

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http://dx.doi.org/10.1016/j.jpeds.2020.04.057DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7204729PMC
July 2020

Rapid Implementation of an Adult Coronavirus Disease 2019 Unit in a Children's Hospital.

J Pediatr 2020 Jul 4;222:22-27. Epub 2020 May 4.

Department of Pediatrics, Children's Hospital at Montefiore, Bronx, NY; Albert Einstein College of Medicine, Bronx, NY.

Objective: To describe the rapid implementation of an adult coronavirus disease 2019 (COVID-19) unit using pediatric physician and nurse providers in a children's hospital and to examine the characteristics and outcomes of the first 100 adult patients admitted.

Study Design: We describe our approach to surge-in-place at a children's hospital to meet the local demands of the COVID-19 pandemic. Instead of redeploying pediatric providers to work with internist-led teams throughout a medical center, pediatric physicians and nurses organized and staffed a 40-bed adult COVID-19 treatment unit within a children's hospital. We adapted internal medicine protocols, developed screening criteria to select appropriate patients for admission, and reorganized staffing and equipment to accommodate adult patients with COVID-19. We used patient counts and descriptive statistics to report sociodemographic, system, and clinical outcomes.

Results: The median patient age was 46 years; 69% were male. On admission, 78 (78%) required oxygen supplementation. During hospitalization, 13 (13%) eventually were intubated. Of the first 100 patients, 14 are still admitted to a medical unit, 6 are in the intensive care unit, 74 have been discharged, 4 died after transfer to the intensive care unit, and 2 died on the unit. The median length of stay for discharged or deceased patients was 4 days (IQR 2, 7).

Conclusions: Our pediatric team screened, admitted, and cared for hospitalized adults by leveraging the familiarity of our system, adaptability of our staff, and high-quality infrastructure. This experience may be informative for other healthcare systems that will be redeploying pediatric providers and nurses to address a regional COVID-19 surge elsewhere.
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http://dx.doi.org/10.1016/j.jpeds.2020.04.060DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7196893PMC
July 2020

Pathways for Improving Inpatient Pediatric Asthma Care (PIPA): A Multicenter, National Study.

Pediatrics 2020 06 6;145(6). Epub 2020 May 6.

Children's National Hospital, Washington, District of Columbia.

Background And Objectives: Pathways guide clinicians through evidence-based care of specific conditions. Pathways have been demonstrated to improve inpatient asthma care but mainly in studies at large, tertiary children's hospitals. It remains unclear if these effects are generalizable across diverse hospital settings. Our objective was to improve inpatient asthma care by implementing pathways in a diverse, national sample of hospitals.

Methods: We used a learning collaborative model. Pathway implementation strategies included local champions, external facilitators and/or mentors, educational seminars, quality improvement methods, and audit and feedback. Outcomes included length of stay (LOS) (primary), early administration of metered-dose inhalers, screening for secondhand tobacco exposure and referral to cessation resources, and 7-day hospital readmissions or emergency revisits (balancing). Hospitals reviewed a sample of up to 20 charts per month of children ages 2 to 17 years who were admitted with a primary diagnosis of asthma (12 months before and 15 months after implementation). Analyses were done by using multilevel regression models with an interrupted time series approach, adjusting for patient characteristics.

Results: Eighty-five hospitals enrolled (40 children's and 45 community); 68 (80%) completed the study ( = 12 013 admissions). Pathways were associated with increases in early administration of metered-dose inhalers (odds ratio: 1.18; 95% confidence interval [CI]: 1.14-1.22) and referral to smoking cessation resources (odds ratio: 1.93; 95% CI: 1.27-2.91) but no statistically significant changes in other outcomes, including LOS (rate ratio: 1.00; 95% CI: 0.96-1.06). Most hospitals (65%) improved in at least 1 outcome.

Conclusions: Pathways did not significantly impact LOS but did improve quality of asthma care for children in a diverse, national group of hospitals.
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http://dx.doi.org/10.1542/peds.2019-3026DOI Listing
June 2020

Implementing pediatric inpatient asthma pathways.

J Asthma 2020 Mar 18:1-10. Epub 2020 Mar 18.

Department of Pediatrics, University of California, San Francisco, CA, USA.

are succinct, operational versions of evidence-based guidelines. Studies have demonstrated pathways improve quality of care for children hospitalized with asthma, but we have limited information on other key factors to guide hospital leaders and clinicians in pathway implementation efforts. Our objective was to evaluate the adoption, implementation, and reach of inpatient pediatric asthma pathways. This was a mixed-methods study of hospitals participating in a national collaborative to implement pathways. Data sources included electronic surveys of implementation leaders and staff, field observations, and chart review of children ages 2-17 years admitted with a primary diagnosis of asthma. Outcomes included by hospitals, pathway factors, and of pathways to children hospitalized with asthma. Quantitative data were analyzed using descriptive statistics and multivariable regression. Qualitative data were analyzed using thematic content analysis. Eighty-five hospitals enrolled; 68 (80%) adopted/completed the collaborative. These 68 hospitals implemented pathways with overall high fidelity, implementing a median of 5 of 5 core pathway components (Interquartile Range [IQR] 4-5) in a median of 5 months (IQR 3-9). Implementation teams reported a median time cost of 78 h (IQR: 40-120) for implementation. Implementation leaders reported the values of pathway implementation included improvements in care, enhanced interdisciplinary collaboration, and access to educational resources. Leaders reported barriers in modifying electronic health records (EHRs), and only 63% of children had electronic pathway orders placed. Hospitals implemented pathways with high fidelity. Barriers in modifying EHRs may have limited the reach of pathways to children hospitalized with asthma.
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http://dx.doi.org/10.1080/02770903.2020.1741612DOI Listing
March 2020

50 Years Ago in TheJournalofPediatrics: Acceptance of Unsalted Strained Foods by Normal Infants.

J Pediatr 2020 02;217:58

Department of Pediatrics, Children's Hospital at Montefiore, Albert Einstein College of Medicine, Bronx, New York.

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http://dx.doi.org/10.1016/j.jpeds.2019.08.026DOI Listing
February 2020

50 Years Ago in TheJournalofPediatrics: Pyloric Stenosis in the Racial Groups of Hawaii.

J Pediatr 2020 01;216:50

Department of Pediatrics, Albert Einstein School of Medicine and Children's Hospital at Montefiore, New York, New York.

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http://dx.doi.org/10.1016/j.jpeds.2019.07.045DOI Listing
January 2020

50 Years Ago in TheJournal ofPediatrics: Fifty-Two Forms of Childhood Cancer, United States Mortality Experience, 1960-1966.

J Pediatr 2019 10;213:148

University of California, San Francisco, San Francisco, California.

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http://dx.doi.org/10.1016/j.jpeds.2019.04.010DOI Listing
October 2019

Depression, Anxiety, and Emergency Department Use for Asthma.

Pediatrics 2019 10;144(4)

Departments of Pediatrics.

Background And Objectives: Asthma is responsible for ∼1.7 million emergency department (ED) visits annually in the United States. Studies in adults have shown that anxiety and depression are associated with increased asthma-related ED use. Our objective was to assess this association in pediatric patients with asthma.

Methods: We identified patients aged 6 to 21 years with asthma in the Massachusetts All-Payer Claims Database for 2014 to 2015 using codes. We examined the association between the presence of anxiety, depression, or comorbid anxiety and depression and the rate of asthma-related ED visits per 100 child-years using bivariate and multivariable analyses with negative binomial regression.

Results: Of 65 342 patients with asthma, 24.7% had a diagnosis of anxiety, depression, or both (11.2% anxiety only, 5.8% depression only, and 7.7% both). The overall rate of asthma-related ED use was 17.1 ED visits per 100 child-years (95% confidence interval [CI]: 16.7-17.5). Controlling for age, sex, insurance type, and other chronic illness, patients with anxiety had a rate of 18.9 (95% CI: 17.0-20.8) ED visits per 100 child-years, patients with depression had a rate of 21.7 (95% CI: 18.3-25.0), and patients with both depression and anxiety had a rate of 27.6 (95% CI: 24.8-30.3). These rates were higher than those of patients who had no diagnosis of anxiety or depression (15.5 visits per 100 child-years; 95% CI: 14.5-16.4; < .001).

Conclusions: Children with asthma and anxiety or depression alone, or comorbid anxiety and depression, have higher rates of asthma-related ED use compared with those without either diagnosis.
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http://dx.doi.org/10.1542/peds.2019-0856DOI Listing
October 2019

Step-Up Therapy in Black Children and Adults with Poorly Controlled Asthma.

N Engl J Med 2019 09;381(13):1227-1239

From National Jewish Health (M.E.W., R.C., J.T.O.), Denver, and University of Colorado School of Medicine (M.E.W., S.J.S., R.C., F.H., J.T.O.) and Children's Hospital Colorado (S.J.S.), Aurora - all in Colorado; Wake Forest School of Medicine (V.E.O., W.C.M., S.P.P.), Winston-Salem, North Carolina Clinical Research (C.F.L.), Raleigh, and Duke University Medical Center (N.L., L.Q.), Durham - all in North Carolina; Ann and Robert H. Lurie Children's Hospital of Chicago (J.A.P., R.G.R.), University of Illinois at Chicago (J.A.K., H.K.), Rush University Medical Center (J.M.), University of Chicago (E.N., J.S., S. White), and Northwestern University Feinberg School of Medicine (L.J.S.) - all in Chicago; Penn State University (V.C., S.J.K., D.M.), Hershey, and Allegheny General Hospital (D.G.) and University of Pittsburgh Medical Center (S. Wenzel), Pittsburgh - all in Pennsylvania; Nemours Children's Health System, Jacksonville (J.J.L., K.V.B., J.L.), and University of South Florida Morsani College of Medicine, Tampa (J.-C.C.) - both in Florida; University of Arizona Health Sciences, Tucson (E.R.B., M.K., F.M., D.A.M.); Washington University School of Medicine, St. Louis (L.B.B., A.B., M.C.); University of California, San Francisco (UCSF), San Francisco (M.B., M.D.C., S.C.L., D.L.) and UCSF Benioff Children's Hospital, Oakland (M.B., D.L.) - both in California; Brigham and Women's Hospital and Harvard Medical School (J.-C.C., N.G., E.I.) and Boston Children's Hospital (W.P., W.S.) - all in Boston; University Hospitals Rainbow Babies and Children's Hospital, Case Western Reserve University School of Medicine, Cleveland (J.F.C., K.R.); University of Wisconsin-Madison, Madison (L.D., D.J.J., R.F.L., C.A.S.) and Aurora Sinai Medical Center, Milwaukee (L.S.-V.) - both in Wisconsin; Columbia University Irving Medical Center, New York, (E.D.); Emory University, Atlanta (A.M.F.); and University of New Mexico, Albuquerque (H.R.).

Background: Morbidity from asthma is disproportionately higher among black patients than among white patients, and black patients constitute the minority of participants in trials informing treatment. Data indicate that patients with inadequately controlled asthma benefit more from addition of a long-acting beta-agonist (LABA) than from increased glucocorticoids; however, these data may not be informative for treatment in black patients.

Methods: We conducted two prospective, randomized, double-blind trials: one involving children and the other involving adolescents and adults. In both trials, the patients had at least one grandparent who identified as black and had asthma that was inadequately controlled with low-dose inhaled glucocorticoids. We compared combinations of therapy, which included the addition of a LABA (salmeterol) to an inhaled glucocorticoid (fluticasone propionate), a step-up to double to quintuple the dose of fluticasone, or both. The treatments were compared with the use of a composite measure that evaluated asthma exacerbations, asthma-control days, and lung function; data were stratified according to genotypic African ancestry.

Results: When quintupling the dose of fluticasone (to 250 μg twice a day) was compared with adding salmeterol (50 μg twice a day) and doubling the fluticasone (to 100 μg twice a day), a superior response occurred in 46% of the children with quintupling the fluticasone and in 46% of the children with doubling the fluticasone and adding salmeterol (P = 0.99). In contrast, more adolescents and adults had a superior response to added salmeterol than to an increase in fluticasone (salmeterol-low-dose fluticasone vs. medium-dose fluticasone, 49% vs. 28% [P = 0.003]; salmeterol-medium-dose fluticasone vs. high-dose fluticasone, 49% vs. 31% [P = 0.02]). Neither the degree of African ancestry nor baseline biomarkers predicted a superior response to specific treatments. The increased dose of inhaled glucocorticoids was associated with a decrease in the ratio of urinary cortisol to creatinine in children younger than 8 years of age.

Conclusions: In contrast to black adolescents and adults, almost half the black children with poorly controlled asthma had a superior response to an increase in the dose of an inhaled glucocorticoid and almost half had a superior response to the addition of a LABA. (Funded by the National Heart, Lung, and Blood Institute; BARD ClinicalTrials.gov number, NCT01967173.).
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http://dx.doi.org/10.1056/NEJMoa1905560DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7026584PMC
September 2019

Exacerbation-prone asthma in the context of race and ancestry in Asthma Clinical Research Network trials.

J Allergy Clin Immunol 2019 12 11;144(6):1524-1533. Epub 2019 Sep 11.

Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.

Background: Minority groups of African descent experience disproportionately greater asthma morbidity compared with other racial groups, suggesting that genetic variation from a common ancestry could influence exacerbation risk.

Objective: We evaluated clinical trial measures in the context of self-reported race and genetic ancestry to identify risk factors for asthma exacerbations.

Methods: One thousand eight hundred forty multiethnic subjects from 12 Asthma Clinical Research Network and AsthmaNet trials were analyzed for incident asthma exacerbations with Poisson regression models that included clinical measures, self-reported race (black, non-Hispanic white, and other), and estimates of global genetic African ancestry in a subgroup (n = 760).

Results: Twenty-four percent of 1840 subjects self-identified as black. Black and white subjects had common risk factors for exacerbations, including a history of 2 or more exacerbations in the previous year and FEV percent predicted values, whereas chronic sinusitis, allergic rhinitis, and gastroesophageal reflux disease were only associated with increased exacerbation risk in black subjects. In the combined multiethnic cohort, neither race (P = .30) nor percentage of genetic African ancestry as a continuous variable associated with exacerbation risk (adjusted rate ratio [RR], 1.26 [95% CI, 0.94-1.70; P = .13]; RR per 1-SD change [32% ancestry], 0.97 [95% CI, 0.78-1.19; P = .74]). However, in 161 black subjects with genetic data, those with African ancestry greater than the median (≥82%) had a significantly greater risk of exacerbation (RR, 3.06 [95% CI, 1.09-8.6; P = .03]).

Conclusion: Black subjects have unique risk factors for asthma exacerbations, of which global African genetic ancestry had the strongest effect.
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http://dx.doi.org/10.1016/j.jaci.2019.08.033DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6931257PMC
December 2019

Author Correction: Elevated faecal 12,13-diHOME concentration in neonates at high risk for asthma is produced by gut bacteria and impedes immune tolerance.

Nat Microbiol 2019 Nov;4(11):2020

Division of Gastroenterology, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.
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http://dx.doi.org/10.1038/s41564-019-0574-7DOI Listing
November 2019

Elevated faecal 12,13-diHOME concentration in neonates at high risk for asthma is produced by gut bacteria and impedes immune tolerance.

Nat Microbiol 2019 11 22;4(11):1851-1861. Epub 2019 Jul 22.

Division of Gastroenterology, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.

Neonates at risk of childhood atopy and asthma exhibit perturbation of the gut microbiome, metabolic dysfunction and increased concentrations of 12,13-diHOME in their faeces. However, the mechanism, source and contribution of this lipid to allergic inflammation remain unknown. Here, we show that intra-abdominal treatment of mice with 12,13-diHOME increased pulmonary inflammation and decreased the number of regulatory T (T) cells in the lungs. Treatment of human dendritic cells with 12,13-diHOME altered expression of PPARγ-regulated genes and reduced anti-inflammatory cytokine secretion and the number of T cells in vitro. Shotgun metagenomic sequencing of neonatal faeces indicated that bacterial epoxide hydrolase (EH) genes are more abundant in the gut microbiome of neonates who develop atopy and/or asthma during childhood. Three of these bacterial EH genes (3EH) specifically produce 12,13-diHOME, and treatment of mice with bacterial strains expressing 3EH caused a decrease in the number of lung T cells in an allergen challenge model. In two small birth cohorts, an increase in the copy number of 3EH or the concentration of 12,13-diHOME in the faeces of neonates was found to be associated with an increased probability of developing atopy, eczema or asthma during childhood. Our data indicate that elevated 12,13-diHOME concentrations impede immune tolerance and may be produced by bacterial EHs in the neonatal gut, offering a mechanistic link between perturbation of the gut microbiome during early life and atopy and asthma during childhood.
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http://dx.doi.org/10.1038/s41564-019-0498-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6830510PMC
November 2019

Higher eGFR at Dialysis Initiation Is Not Associated with a Survival Benefit in Children.

J Am Soc Nephrol 2019 08 18;30(8):1505-1513. Epub 2019 Jul 18.

Division of Nephrology.

Background: Study findings suggest that initiating dialysis at a higher eGFR level in adults with ESRD does not improve survival. It is less clear whether starting dialysis at a higher eGFR is associated with a survival benefit in children with CKD.

Methods: To investigate this issue, we performed a retrospective cohort study of pediatric patients aged 1-18 years who, according to the US Renal Data System, started dialysis between 1995 and 2015. The primary predictor was eGFR at the time of dialysis initiation, categorized as higher (eGFR>10 ml/min per 1.73 m) versus lower eGFR (eGFR≤10 ml/min per 1.73 m).

Results: Of 15,170 children, 4327 (29%) had a higher eGFR (median eGFR, 12.8 ml/min per 1.73 m) at dialysis initiation. Compared with children with a lower eGFR (median eGFR, 6.5 ml/min per 1.73 m), those with a higher eGFR at dialysis initiation were more often white, girls, underweight or obese, and more likely to have GN as the cause of ESRD. The risk of death was 1.36 times higher (95% confidence interval, 1.24 to 1.50) among children with a higher (versus lower) eGFR at dialysis initiation. The association between timing of dialysis and survival differed by treatment modality-hemodialysis versus peritoneal dialysis (<0.001 for interaction)-and was stronger among children initially treated with hemodialysis (hazard ratio, 1.56, 95% confidence interval, 1.39 to 1.75; versus hazard ratio, 1.07, 95% confidence interval, 0.91 to 1.25; respectively).

Conclusions: In children with ESRD, a higher eGFR at dialysis initiation is associated with lower survival, particularly among children whose initial treatment modality is hemodialysis.
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http://dx.doi.org/10.1681/ASN.2018111130DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6683704PMC
August 2019

Minimizing the Relationship Between Early Formula Use and Breastfeeding Cessation by Limiting Formula Volume.

Breastfeed Med 2019 10 16;14(8):533-537. Epub 2019 Jul 16.

Department of Pediatrics, University of California San Francisco, San Francisco, California.

Early exposure to formula can interfere with successful long-term breastfeeding. The objective of this study was to determine whether limiting the volume of formula used in the first month attenuates formula's detrimental impact on long-term breastfeeding success. Using detailed data on dietary intake from a randomized clinical trial, we conducted a secondary analysis of the association between volume of formula received in the first month and breastfeeding cessation before 6 and 12 months of age. We used descriptive statistics and multivariable logistic regression, respectively, to explore this association without and with adjustment for demographic and clinical predictors of infant feeding. Among 199 breastfeeding infants, 80 (40%) received formula daily at 1 month of age, and breastfeeding cessation before 6 and 12 months of age was higher for these infants (46% and 67%) than for those breastfed exclusively (6% and 27%) ( < 0.0005 for each). The risk of cessation did not differ between those who received ≤4 fl oz daily in the first month (11%) and those who did not receive formula in the first month (6%) ( = 0.42). Adjusting for gestational age, race/ethnicity, income, and intention to breastfeed exclusively, the odds ratio for the outcome of cessation before 6 months was 1.15 (95% confidence interval = 0.20-6.67) for infants who received ≤4 fl oz daily compared with those who breastfed exclusively. Limiting formula volumes to ≤4 fl oz daily may attenuate the deleterious association between early formula use and subsequent successful breastfeeding.
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http://dx.doi.org/10.1089/bfm.2019.0055DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6791478PMC
October 2019