High-Dose DHA for Bronchopulmonary Dysplasia

Overseen By Etienne Pronovost, BSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: CHU de Quebec-Universite Laval

Must be taking: High-dose DHA

Disqualifiers: Born after 2010, others

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 36 weeks' PMA

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if high doses of DHA (a type of omega-3 fatty acid) can reduce the risk of severe bronchopulmonary dysplasia (a serious lung condition) in very premature babies by the time they reach 36 weeks of development. Researchers will compare babies receiving high-dose DHA supplements with those who do not, considering factors like sex and birth size. This trial suits preterm infants born before 29 weeks who are receiving modern respiratory care. As an unphased study, it offers a unique opportunity to contribute to groundbreaking research that could improve outcomes for future preterm infants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that high-dose DHA, a type of omega-3 fatty acid, has been studied for its effects on bronchopulmonary dysplasia (BPD), a lung condition in premature babies. One study found that high-dose DHA was not harmful for severe BPD. However, another study found a slightly higher risk of severe BPD in babies who received high-dose DHA compared to those who did not. Specifically, 34.4% of babies in the DHA group had severe BPD, compared to 31.9% in the group that did not receive DHA. This suggests that while high-dose DHA is generally safe, it may not reduce the risk of severe BPD and might slightly increase it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for bronchopulmonary dysplasia (BPD) focus on managing symptoms and providing supportive care, like oxygen therapy and mechanical ventilation. However, high-dose DHA is unique because it involves enteral supplementation with a high amount of docosahexaenoic acid (DHA) during the neonatal period. DHA is an omega-3 fatty acid that plays a crucial role in reducing inflammation and supporting lung development. Researchers are excited about this treatment because it targets the underlying inflammation associated with BPD, potentially offering a proactive approach to improving lung health in newborns rather than just managing symptoms.

What evidence suggests that high-dose DHA might be an effective treatment for bronchopulmonary dysplasia?

This trial will compare high-dose DHA with a control group receiving standard care or a placebo. Studies have shown mixed results on whether high doses of docosahexaenoic acid (DHA) help treat bronchopulmonary dysplasia (BPD) in premature babies. One study found that giving DHA through feeding did not significantly reduce the risk of severe BPD compared to a group that did not receive it. Another study showed similar results, indicating that high-dose DHA did not lower the risk of BPD in babies born before 29 weeks. However, the treatment was not harmful. While some research suggests DHA might help some babies avoid BPD, the overall evidence does not strongly support its effectiveness for this condition. ^{1 3 5 6 7}

Who Is on the Research Team?

Mireille Guillot, MD

Principal Investigator

CHU de Québec-Université Laval

Jacqueline F. Gould, PhD

Principal Investigator

South Australian Health and Medical Research Institute

Ibrahim Mohamed, MD, PhD

Principal Investigator

St. Justine's Hospital

Marc Beltempo, MD

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Isabelle Marc, MD, PhD

Principal Investigator

CHU de Québec-Université Laval

Pascal M. Lavoie, MD, PhD

Principal Investigator

University of British Columbia

Andrew J. McPhee, MB, BS

Principal Investigator

South Australian Health and Medical Research Institute

David Simonyan, MSc

Principal Investigator

CHU de Québec-Université Laval

Etienne Pronovost, BSc

Principal Investigator

CHU de Québec-Université Laval

Amélie Boutin, PhD

Principal Investigator

CHU de Québec-Université Laval

Isabel Fortier, PhD

Principal Investigator

Research Institute of the McGill University Health Centre

Thomas R. Sullivan, PhD

Principal Investigator

South Australian Health and Medical Research Institute

Maria Makrides, PhD

Principal Investigator

South Australian Health and Medical Research Institute

Carmel T. Collins, PhD

Principal Investigator

South Australian Health and Medical Research Institute

Lynne Moore, PhD

Principal Investigator

Laval University

Are You a Good Fit for This Trial?

This trial is for very preterm infants born at less than 29 weeks of gestation. It includes those in registered clinical trials with data allowing for BPD severity classification at 36 weeks' PMA, and who are receiving high-dose DHA or a control treatment. Infants from trials after 2010 with modern respiratory care practices qualify, but not if the study involves intravenous DHA or combined interventions.

Inclusion Criteria

The trial must have collected data to classify the severity of bronchopulmonary dysplasia (BPD) according to Jensen's criteria when the infants are 36 weeks old.

My baby was born before 29 weeks of pregnancy.

My newborn is receiving high-dose DHA through feeding.

Exclusion Criteria

Studies testing more than one treatment at the same time, like combining DHA with other nutrients or fatty acids.

I am considering a trial that involves DHA treatments through an IV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Enteral supplementation with high-dose DHA in the neonatal period

Up to 36 weeks' PMA

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 40 weeks' PMA

What Are the Treatments Tested in This Trial?

Interventions

• Control
• High-dose DHA

Trial Overview The study tests if high-dose DHA given through feeding (enteral) reduces severe bronchopulmonary dysplasia risk in very preterm infants compared to a control group with no or low-dose DHA. The effect will be analyzed overall and in subgroups based on sex, age, size at birth, and delivery method.

How Is the Trial Designed?

Group I: High-dose DHA Experimental Treatment 1 Intervention

Enteral supplementation with high-dose DHA in the neonatal period.

Group II: Control Placebo Group 1 Intervention

Control.

Who Is Running the Clinical Trial?

CHU de Quebec-Universite Laval

Lead Sponsor

Trials

177

Recruited

110,000+

South Australian Health and Medical Research Institute

Collaborator

Trials

14

Recruited

6,800+

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Trials

476

Recruited

170,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Laval University

Collaborator

Trials

439

Recruited

178,000+

Citations

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

a collaborative individual participant data meta-analysis - PMC This work used an IPD meta-analysis methodology, providing robust findings suggesting that high-dose DHA is not harmful for severe BPD.

2. 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 ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1611942

Docosahexaenoic Acid and Bronchopulmonary Dysplasia ... Enteral DHA supplementation at a dose of 60 mg per kilogram per day did not result in a lower risk of physiological bronchopulmonary dysplasia than a control ...

4. bmjopen.bmj.com bmjopen.bmj.com/content/13/7/e076223

a collaborative study protocol for an individual participant ... This study will aim to determine whether high-dose DHA enteral supplementation during the neonatal period is associated with the risk of severe BPD at 36 weeks' ...

5. 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 ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2802678

Association Between Enteral Supplementation With High- ... These results suggest that high-dose DHA enteral supplementation should not be recommended for prevention of BPD in very preterm infants.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40180500/

High-dose docosahexaenoic acid for bronchopulmonary ... Severe BPD in survivors occurred in 290/843 (34.4%) infants in the DHA group and 268/841 (31.9%) infants in the placebo group {relative risk [RR], 1.06 [95% ...