Effect of Maternal Docosahexaenoic Acid Supplementation on Bronchopulmonary Dysplasia-Free Survival in Breastfed Preterm Infants: A Randomized Clinical Trial
Marc I, Piedboeuf B, Lacaze-Masmonteil T, Fraser W, Mâsse B, Mohamed I, Qureshi M, Afifi J, Lemyre B, Caouette G, Bartholomew J, Nuyt AM, Julien P, Synnes A, Lucas M, Perreault T, Strueby L, Cieslak Z, Yusuf K, Pelligra G, Massé E, Larsen B, de Cabo C, Ruth C, Khurshid F, Lavoie PM
JAMA · 63 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Clinical events such as disease or death
Who paid for it
- Funding
- Funding not disclosed
Publication
- Published
- 2020-07-14 · JAMA · vol. 324 · issue 2 · p. 157
- Publisher
- American Medical Association
- Cited
- 74 citations · more than 96% of similar papers · 4.5× the field average
- Impact
- Top 10% most cited in its field
- References
- 32 works
- Access
- Free to read
- Research areas
- Neonatal Respiratory Health Research · Fatty Acid Research and Health · Infant Development and Preterm Care
- Keywords
- Bronchopulmonary dysplasia, Medicine, Pediatrics, Gestational age, Gestation, Randomized controlled trial, Placebo, Retinopathy of prematurity, Docosahexaenoic acid, Neonatal intensive care unit, Pregnancy, Obstetrics, Internal medicine, Fatty acid, Polyunsaturated fatty acid
- MeSH
- humans, bronchopulmonary dysplasia, docosahexaenoic acids, sample size, patient compliance, gestational age, lactation, dietary supplements, adult, infant, newborn, female, infant, extremely premature, equivalence trials as topic
26 authors
From CA
- Isabelle Marc · correspondingCentre hospitalier universitaire de Québec; Université Laval
- Bruno PiedbœufCentre hospitalier universitaire de Québec; Université Laval
- Thierry Lacaze‐MasmonteilUniversity of Calgary; Foothills Medical Centre
- William Donald FraserCentre Hospitalier Universitaire de Sherbrooke
- Benoît R. MâsseCentre Hospitalier Universitaire Sainte-Justine; Université de Montréal
- Ibrahim MohamedCentre Hospitalier Universitaire Sainte-Justine; Université de Montréal
Abstract
Importance
Maternal docosahexaenoic acid (DHA) supplementation may prevent bronchopulmonary dysplasia, but evidence remains inconclusive.
Objective
To determine whether maternal DHA supplementation during the neonatal period improves bronchopulmonary dysplasia-free survival in breastfed infants born before 29 weeks of gestation.
Design, setting, and participants
Superiority, placebo-controlled randomized clinical trial at 16 Canadian neonatal intensive care units (June 2015-April 2018 with last infant follow-up in July 2018). Lactating women who delivered before 29 weeks of gestation were enrolled within 72 hours of delivery. The trial intended to enroll 800 mothers, but was stopped earlier.
Interventions
There were 232 mothers (273 infants) assigned to oral capsules providing 1.2 g/d of DHA from randomization to 36 weeks' postmenstrual age and 229 mothers (255 infants) assigned to placebo capsules.
Main outcomes and measures
The primary outcome was bronchopulmonary dysplasia-free survival in infants at 36 weeks' postmenstrual age. There were 22 secondary outcomes, including mortality and bronchopulmonary dysplasia.
Results
Enrollment was stopped early due to concern for harm based on interim data from this trial and from another trial that was published during the course of this study. Among 461 mothers and their 528 infants (mean gestational age, 26.6 weeks [SD, 1.6 weeks]; 253 [47.9%] females), 375 mothers (81.3%) and 523 infants (99.1%) completed the trial. Overall, 147 of 268 infants (54.9%) in the DHA group vs 157 of 255 infants (61.6%) in the placebo group survived without bronchopulmonary dysplasia (absolute difference, -5.0% [95% CI, -11.6% to 2.6%]; relative risk, 0.91 [95% CI, 0.80 to 1.04], P = .18). Mortality occurred in 6.0% of infants in the DHA group vs 10.2% of infants in the placebo group (absolute difference, -3.9% [95% CI, -6.8% to 1.4%]; relative risk, 0.61 [95% CI, 0.33 to 1.13], P = .12). Bronchopulmonary dysplasia occurred in 41.7% of surviving infants in the DHA group vs 31.4% in the placebo group (absolute difference, 11.5% [95% CI, 2.3% to 23.2%]; relative risk, 1.36 [95% CI, 1.07 to 1.73], P = .01). Of 22 prespecified secondary outcomes, 19 were not significantly different.
Conclusions and relevance
Among breastfed preterm infants born before 29 weeks of gestation, maternal docosahexaenoic acid supplementation during the neonatal period did not significantly improve bronchopulmonary dysplasia-free survival at 36 weeks' postmenstrual age compared with placebo. Study interpretation is limited by early trial termination.
Trial registration
ClinicalTrials.gov Identifier: NCT02371460.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
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