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

Must not be taking: DHA supplements

Disqualifiers: Congenital malformations, Other trials, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Until 36 weeks PMA

800 Participants Needed

What You Need to Know Before You Apply

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.

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 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. ^{1 2 3 4 5}

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. ^{2 3 4 5 6}

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. ^{1 3 4 5 7}

Who Is on the 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

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

Randomization before or at 72 hours post delivery

I am 16 years old or older.

No contraindication to breastfeeding

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)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: DHA-rich algal oil Experimental Treatment 1 Intervention

1200mg DHA per day

Group II: Placebo Placebo Group 1 Intervention

No supplementation in DHA

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Biomarkers of lung alveolarization and microvascular maturation in response to intermittent hypoxia and/or early antioxidant/fish oil supplementation in neonatal rats. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Maternal Docosahexaenoic Acid Supplementation on Bronchopulmonary Dysplasia-Free Survival in Breastfed Preterm Infants: A Randomized Clinical Trial. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effect of arachidonic and docosahexaenoic acid supplementation on respiratory outcomes and neonatal morbidities in preterm infants. [2023]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Use of SMOF lipid emulsion in very preterm infants does not affect the incidence of bronchopulmonary dysplasia-free survival. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Association Between Enteral Supplementation With High-Dose Docosahexaenoic Acid and Risk of Bronchopulmonary Dysplasia in Preterm Infants: A Systematic Review and Meta-analysis. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Docosahexaenoic acid and bronchopulmonary dysplasia in preterm infants: a systematic review and meta-analysis. [2022]