Omega-3 Supplementation for Bronchopulmonary Dysplasia
(MOBYDIck Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking more than 250 mg of DHA daily, you may not be eligible to participate.
What data supports the effectiveness of the treatment DHA-rich algal oil for bronchopulmonary dysplasia?
Some studies suggest that DHA (a type of omega-3 fatty acid) supplementation might help prevent lung problems in very preterm infants, but the evidence is not clear. Research is ongoing to determine if high doses of DHA can reduce the risk of bronchopulmonary dysplasia, a serious lung condition in preterm babies.12345
Is DHA-rich algal oil safe for humans?
Research on DHA (a type of omega-3) in preterm infants shows mixed results, with some studies suggesting a potential increased risk of bronchopulmonary dysplasia (a lung condition) when used in high doses. However, there is no conclusive evidence of harm, and it has been used in various studies without major safety concerns.23456
How does DHA-rich algal oil treatment differ from other treatments for bronchopulmonary dysplasia?
DHA-rich algal oil is unique because it uses docosahexaenoic acid (DHA), a type of omega-3 fatty acid known for its anti-inflammatory properties, which may help manage bronchopulmonary dysplasia (BPD) in preterm infants. Unlike other treatments, it focuses on dietary supplementation to potentially reduce inflammation and improve respiratory outcomes.23467
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.
Research Team
Benoît Mâsse, PhD
Principal Investigator
CHU Sainte-Justine, Université de Montreal
Thierry Lacaze, MD, PhD
Principal Investigator
Children's Hospital of Eastern Ontario, University of Ottawa
Anne-Monique Nuyt, MD, PhD
Principal Investigator
CHU Sainte-Justine, Université de Montreal
William Fraser, MD, MSc
Principal Investigator
Université de Sherbrooke
Isabelle Marc, MD, PhD
Principal Investigator
CHU de Québec, Université Laval
Pascal Lavoie, MD, PhD
Principal Investigator
Children's and Women's Health Centre of BC, University of British Columbia
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Mothers receive either DHA supplementation or placebo while providing breast-milk to their infants
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Assessment of neuro-developmental outcomes and other health metrics at 18-22 months corrected age
Extended Follow-up
Assessment of child health-related quality of life and other outcomes at 60 months corrected age
Treatment Details
Interventions
- DHA-rich algal oil
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
CHU de Quebec-Universite Laval
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Laval University
Collaborator