Omega-3 Supplementation for Bronchopulmonary Dysplasia
(MOBYDIck Trial)

Recruiting in Palo Alto (17 mi)

+15 other locations

Overseen byPascal Lavoie, MD, PhD

Age: Any Age

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: CHU de Quebec-Universite Laval

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for breastfeeding mothers aged 16 or older, who delivered pre-term (between 23 and less than 29 weeks of gestation) and plan to provide breast milk to their infants. Mothers can't join if they've been in another drug trial within the last 3 months, are taking high doses of DHA, or if their infant has significant birth defects.

Inclusion Criteria

Randomization before or at 72 hours post delivery

I am 16 years old or older.

No contraindication to breastfeeding

+2 more

Exclusion Criteria

Significant congenital malformations in the infant (or one of the infants in case of multiple pregnancy)

I have been taking more than 250 mg of DHA daily for the last 3 months.

Mother who is currently enrolled or has participated in another clinical trial in which she had received an investigational drug or intervention within 3 months of the date of randomization (unless approved by the Trial Coordinating Centre)

+3 more

Participant Groups

The study tests whether DHA-rich algal oil given to lactating mothers helps prevent bronchopulmonary dysplasia in very premature infants. Participants are randomly divided into two groups: one receives DHA supplementation; the other gets a placebo.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DHA-rich algal oilExperimental Treatment1 Intervention

1200mg DHA per day

Group II: PlaceboPlacebo Group1 Intervention

No supplementation in DHA