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 citas
Etiquetas de revisión
Financiación no declaradaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2020-07-14 · JAMA · vol. 324 · número 2 · pág. 157
- Editorial
- American Medical Association
- Citado
- 74 citas · más que el 96% de estudios similares · 4.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 32 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Neonatal Respiratory Health Research · Fatty Acid Research and Health · Infant Development and Preterm Care
- Palabras clave
- 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 autores
- Isabelle Marc🇨🇦 · autor de correspondenciaCentre hospitalier universitaire de Québec; Université Laval
- Bruno Piedbœuf🇨🇦Centre hospitalier universitaire de Québec; Université Laval
- Thierry Lacaze‐Masmonteil🇨🇦University of Calgary; Foothills Medical Centre
- William Donald Fraser🇨🇦Centre Hospitalier Universitaire de Sherbrooke
- Benoît R. Mâsse🇨🇦Centre Hospitalier Universitaire Sainte-Justine; Université de Montréal
- Ibrahim Mohamed🇨🇦Centre Hospitalier Universitaire Sainte-Justine; Université de Montréal
- Mosarrat J Qureshi🇨🇦Royal Alexandra Hospital
- Jehier K. Afifi🇨🇦Dalhousie University
- Brigitte Lemyre🇨🇦Children's Hospital of Eastern Ontario
- Georges Caouette🇨🇦Centre hospitalier universitaire de Québec; Université Laval
- Julie Bartholomew🇨🇦Jewish General Hospital; McGill University
- Anne Monique Nuyt🇨🇦Centre Hospitalier Universitaire Sainte-Justine; Université de Montréal
- Pierre Julien🇨🇦Centre hospitalier universitaire de Québec; Université Laval
- Anne R. Synnes🇨🇦University of British Columbia
- Michel Lucas🇨🇦Hôpital du Saint-Sacrement; Centre hospitalier universitaire de Québec; Université Laval
- Thérèse Perreault🇨🇦Montreal Children's Hospital; McGill University
- Lannae Strueby🇨🇦University of Saskatchewan
- Zenon Cieslak🇨🇦Royal Columbian Hospital
- Kamran Yusuf🇨🇦University of Calgary
- Gustavo Pelligra🇨🇦Island Health; Victoria General Hospital
- Édith Massé🇨🇦Université de Sherbrooke; Hôpital Fleurimont
- Bodil Katrine Larsen🇨🇦University of Alberta
- Cecilia de Cabo🇨🇦University of Manitoba
- Chelsea Ruth🇨🇦University of Manitoba
- Faiza Khurshid🇨🇦Queen's University
- Pascal M. Lavoie🇨🇦University of British Columbia
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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