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

1801 Participants Needed

Trial Summary

What is the purpose of this trial?

This one-stage individual participant data (IPD) meta-analysis study will aim to determine whether high-dose docosahexaenoic acid (DHA) enteral supplementation during the neonatal period is associated with the risk for severe bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age (PMA) compared to control, in contemporary cohorts of preterm infants born at less than 29 weeks of gestation. The association between high-dose DHA and severe BPD will also be explored in important subgroups according to sex, gestational age, small-for-gestational age and mode of delivery.

Research Team

Lynne Moore, PhD

Principal Investigator

Laval University

Maria Makrides, PhD

Principal Investigator

South Australian Health and Medical Research Institute

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

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

Carmel T. Collins, PhD

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

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

Amélie Boutin, PhD

Principal Investigator

CHU de Québec-Université Laval

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+