800 Participants Needed

Omega-3 Supplementation for Bronchopulmonary Dysplasia

(MOBYDIck Trial)

Recruiting at 15 trial locations
Age: Any Age
Sex: Female
Trial Phase: Phase 3
Sponsor: CHU de Quebec-Universite Laval
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human 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

BM

Benoît Mâsse, PhD

Principal Investigator

CHU Sainte-Justine, Université de Montreal

TL

Thierry Lacaze, MD, PhD

Principal Investigator

Children's Hospital of Eastern Ontario, University of Ottawa

AN

Anne-Monique Nuyt, MD, PhD

Principal Investigator

CHU Sainte-Justine, Université de Montreal

WF

William Fraser, MD, MSc

Principal Investigator

Université de Sherbrooke

IM

Isabelle Marc, MD, PhD

Principal Investigator

CHU de Québec, Université Laval

PL

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

Randomization before or at 72 hours post delivery
I am 16 years old or older.
No contraindication to breastfeeding
See 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)
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Mothers receive either DHA supplementation or placebo while providing breast-milk to their infants

Until 36 weeks PMA

Follow-up

Participants are monitored for safety and effectiveness after treatment

Until 40 weeks PMA

Long-term Follow-up

Assessment of neuro-developmental outcomes and other health metrics at 18-22 months corrected age

18-22 months CA

Extended Follow-up

Assessment of child health-related quality of life and other outcomes at 60 months corrected age

60 months CA

Treatment Details

Interventions

  • DHA-rich algal oil
  • Placebo
Trial Overview 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials
177
Recruited
110,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Laval University

Collaborator

Trials
439
Recruited
178,000+

Findings from Research

In a study involving 120 very preterm infants, supplementation with arachidonic acid (ARA) and docosahexaenoic acid (DHA) significantly reduced the duration of respiratory support needed and lowered oxygen demand compared to a control group receiving medium chain triglycerides (MCT) oil.
The supplementation was found to be safe, with no significant differences in the incidence of bronchopulmonary dysplasia (BPD) or other major morbidities between the treatment and control groups.
Effect of arachidonic and docosahexaenoic acid supplementation on respiratory outcomes and neonatal morbidities in preterm infants.Wendel, K., Aas, MF., Gunnarsdottir, G., et al.[2023]

References

Biomarkers of lung alveolarization and microvascular maturation in response to intermittent hypoxia and/or early antioxidant/fish oil supplementation in neonatal rats. [2023]
Effect of Maternal Docosahexaenoic Acid Supplementation on Bronchopulmonary Dysplasia-Free Survival in Breastfed Preterm Infants: A Randomized Clinical Trial. [2021]
Effect of arachidonic and docosahexaenoic acid supplementation on respiratory outcomes and neonatal morbidities in preterm infants. [2023]
High doses of enteral docosahexaenoic acid omega-3 supplementation for prevention of bronchopulmonary dysplasia in very preterm infants: a protocol for a systematic review and meta-analysis. [2022]
Use of SMOF lipid emulsion in very preterm infants does not affect the incidence of bronchopulmonary dysplasia-free survival. [2022]
Association Between Enteral Supplementation With High-Dose Docosahexaenoic Acid and Risk of Bronchopulmonary Dysplasia in Preterm Infants: A Systematic Review and Meta-analysis. [2023]
Docosahexaenoic acid and bronchopulmonary dysplasia in preterm infants: a systematic review and meta-analysis. [2022]
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