NCT02371460

Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia

Maternal Omega-3 Supplementation to Reduce BronchopulmonarY Dysplasia in Very Preterm Infants (MOBYDIck Trial)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The aim of this randomized controlled trial is to determine whether docosahexaenoic acid (or DHA, an omega-3 lipid) supplementation in lactating mothers providing breast-milk to their infant born below 29 0/7 weeks of gestational age (GA) improves BPD-free survival at 36 weeks post-menstrual age (PMA). Half of participants will receive docosahexaenoic acid (DHA), an omega-3 lipid, while the other half will receive a placebo.

Detailed description

Every year in Canada, 1500 babies who are born early (prematurely) develop a serious lung disease called bronchopulmonary dysplasia (BPD). BPD causes major health problems in these infants, especially in their early childhood. In most situations, breast-milk is the ideal source of nutrition for growth and development of premature babies. However, diets of Canadian mothers are generally deficient in omega-3 lipids (essential fats), resulting in lower protection from these omega-3 lipids in mother's milk-fed infants. Previous research has shown that giving DHA to mothers of premature babies is safe both for the mother and for their baby, and is an efficient way of helping babies meet their dietary requirements from breast-milk. Furthermore, this previous research also suggests that this intervention may reduce the risk of BPD in premature babies receiving breast-milk.

Conditions

• Bronchopulmonary Dysplasia
• Child Development
• Neonatal and Perinatal Conditions

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	DHA-rich algal oil	Mothers will receive a DHA-rich algal oil treatment (400 mg DHA per capsule) three times a day before meals from randomization (\<72 hours post-delivery) until the infant reaches 36 weeks PMA.
COMBINATION_PRODUCT	Placebo	Mothers will receive a placebo capsule three times a day before meals from randomization (\<72 hours post-delivery) until the infant reaches 36 weeks PMA.

Timeline

• Start date: 2015-06-23
• Primary completion: 2019-04-25
• Completion: 2026-03-01
• First posted: 2015-02-25
• Last updated: 2025-02-24

Locations

16 sites across 1 country: Canada