Omega-3 Supplementation for Bronchopulmonary Dysplasia

(MOBYDIck Trial)

Not currently recruiting at 17 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

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. ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

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

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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12002185/

a collaborative individual participant data meta-analysis - PMC

Severe BPD in survivors at 36 wk PMA occurred in 290/843 infants (34.4%) in the DHA group compared with 268/841 infants (31.9%) in the placebo ...

2.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2768134

Effect of Maternal Docosahexaenoic Acid Supplementation ...

A total of 147 of 268 infants (54.9%) in the DHA group survived without bronchopulmonary dysplasia at 36 weeks' postmenstrual age compared with ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02371460

NCT02371460 | Maternal Omega-3 Supplementation to ...

Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia ... 1200mg DHA per day. Intervention/Treatment, Dietary Supplement : DHA-rich algal oil.

4.

nature.com

nature.com/articles/s41598-021-01017-8

Docosahexaenoic acid-rich algae oil supplementation on ...

Human observational studies have shown that low levels of DHA correlate with an increased risk of chronic lung disease in preterm infants. A ...

5.

ajcn.nutrition.org

ajcn.nutrition.org/article/S0002-9165(25)00004-8/pdf

High-dose docosahexaenoic acid for bronchopulmonary ...

Excluding deaths before 36 wk PMA, the primary outcome (i.e., severe BPD at 36 wk. PMA) was available for 843 infants in the DHA group and 841 ...

6.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2802678

Association Between Enteral Supplementation With High- ...

Findings of this study suggest that high-dose DHA enteral supplementation should not be recommended for prevention of BPD in very preterm infants.

7.

withpower.com

withpower.com/trial/omega-3-supplementation-for-bronchopulmonary-dysplasia-8ecd0

Omega-3 Supplementation for Bronchopulmonary Dysplasia

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 ...