Maternal docosahexaenoic acid fails to improve bronchopulmonary dysplasia survival
Click Here to Manage Email Alerts
Maternal docosahexaenoic acid supplementation did not improve bronchopulmonary dysplasia-free survival in breastfed preterm infants compared with placebo, according to results of a randomized clinical trial published in JAMA Network Open.
“The [MOBYDIck] trial was stopped early because data from the interim analysis favored the placebo group, and in view of a concern for harm suggested both by this trial and by the N3RO trial,” Isabelle Marc, MD, PhD, associate professor in the department of pediatrics at Laval University, Québec, Canada, and colleagues wrote. “The primary hypothesis was disproved before the planned enrollment, demonstrating no benefit from docosahexaenoic acid supplementation on bronchopulmonary dysplasia-free survival, regardless of the mode of enteral administration.”
The placebo-controlled, randomized MOBYDIck trial enrolled 461 lactating women (528 infants) from June 2015 to April 2018 who delivered before 29 weeks of gestation at 16 neonatal ICUs in Canada. Mothers were randomly assigned to daily oral capsules containing 1.2 g of docosahexaenoic acid (DHA; 232 mothers, 273 infants) or placebo (229 mothers, 255 infants). Primary outcome was bronchopulmonary dysplasia-free survival in infants at 36 weeks’ postmenstrual age.
In the DHA group, 54.9% of infants survived without bronchopulmonary dysplasia vs. 61.6% of infants in the placebo group (RR = 0.91; 95% CI, 0.8-1.04; P = .18). Six percent of infants in the DHA group died compared with 10.2% of infants in the placebo group (RR = 0.6; 95% CI, 0.33-1.13; P = .12). In surviving infants, bronchopulmonary dysplasia occurred in 41.7% in the DHA group compared with 31.4% in the placebo group (RR = 1.36; 95% CI, 1.07-1.73; P = .01). The researchers observed severe bronchopulmonary dysplasia in 34.9% of infants in the DHA group compared with 25.3% in the placebo group (RR = 1.41; 95% CI, 1.07-1.86; P = .02).
The researchers reported no neonatal adverse events or serious adverse events related to DHA supplementation intervention.
“To the best of our knowledge, there are no data in the literature supporting DHA supplementation reduces the rate of death in this population,” the researchers wrote. “In the absence of an a priori hypothesis and supporting data, an effect of DHA on survival is hypothetical and requires confirmation.”