Clinical Trial

Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia

Study acronym: MOBYDIck
Terminated Phase 3
View on ClinicalTrials.gov →
Why the trial stopped
Recruitment was prematurely terminated by the DSMB due to concern of harm for future participants based on interim data favoring the placebo group, findings from the N3RO trial, and the very low probability of benefit from DHA supplementation
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.
Protocol Amendment History 4 changes
critical Trial terminated 2026-08-14
critical Trial terminated: Recruitment was prematurely terminated by the DSMB due to concern of harm for future participants based on interim data... 2026-08-14
notable Enrollment reduced: 800 -> 461 participants 2026-08-14
minor Completion moved earlier: 2026-03 -> 2023-07-07 2026-08-14
Trial Details
NCT Number NCT02371460
Lead Sponsor CHU de Quebec-Universite Laval
Collaborators: Canadian Institutes of Health Research (CIHR), Laval University
Conditions Bronchopulmonary Dysplasia, Child Development, Neonatal and Perinatal Conditions
Enrollment 461 participants
Start Date 2015-06-23
Primary Completion 2019-04-25 (estimated)
Study Completion 2023-07-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-13