Omega-3 Supplementation for Bronchopulmonary Dysplasia
(MOBYDIck Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether DHA, an omega-3 fat, can improve survival without bronchopulmonary dysplasia, a lung condition, in premature infants. Mothers of these infants will take either a DHA supplement (DHA-rich algal oil) or a placebo while breastfeeding. The study seeks mothers who have recently had a baby born very early (before 29 weeks) and plan to breastfeed. As a Phase 3 trial, it represents the final step before FDA approval, offering a chance to contribute to potentially groundbreaking treatment for premature infants.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that DHA, a type of omega-3 fat, is safe for use in premature babies. A joint study found that high doses of DHA do not harm babies with severe bronchopulmonary dysplasia (BPD), a lung condition in newborns. Earlier research confirmed its safety for both mothers and their premature babies when mothers take DHA. Although some studies suggest DHA might not prevent BPD, no evidence indicates it causes harm. Overall, DHA supplements are well-tolerated and considered safe based on current research.12345
Why do researchers think this study treatment might be promising for bronchopulmonary dysplasia?
Unlike the standard treatments for bronchopulmonary dysplasia, which often involve respiratory support and medications like diuretics or corticosteroids, the investigational treatment uses DHA-rich algal oil. This treatment is unique because it introduces a high dose of omega-3 fatty acids, specifically 1200mg of DHA per day, which is known for its anti-inflammatory properties. Researchers are excited because this natural, dietary-based approach could reduce inflammation in the lungs more safely and effectively, potentially improving outcomes for those with this condition.
What evidence suggests that DHA-rich algal oil might be an effective treatment for bronchopulmonary dysplasia?
This trial will compare DHA-rich algal oil supplementation with a placebo to assess its effects on bronchopulmonary dysplasia in premature infants. Research has shown that DHA, a type of omega-3 fat, might help reduce lung problems in premature babies. In one study, 54.9% of babies whose mothers took DHA supplements did not develop serious lung issues by 36 weeks after their original due date, suggesting that DHA might help these babies breathe better. Other studies have found that low DHA levels are linked to a higher risk of lung problems in preterm babies. While the results are promising, some studies have shown mixed outcomes. Overall, DHA has shown some potential in improving lung health in premature infants.12467
Who Is on the Research Team?
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
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
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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