Enteral High-dose DHA Supplementation on Bronchopulmonary Dysplasia in Very Preterm Infants: a Collaborative Study

Summary

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.

Conditions

• Bronchopulmonary Dysplasia
• Child Development
• Neonatal and Perinatal Conditions

Interventions

DIETARY_SUPPLEMENT

High-dose DHA

Direct enteral DHA supplementation at a dose of at least 40 mg/kg/day or DHA supplementation of breast milk or formula aiming for at least 0.4% of total fatty acids.

DIETARY_SUPPLEMENT

Control

Control with no or low-dose DHA.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Laval University

  collaborator OTHER

• South Australian Health and Medical Research Institute

  collaborator OTHER

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

  collaborator OTHER

• CHU de Quebec-Universite Laval

  lead OTHER

Principal Investigators

• Isabelle Marc, MD, PhD · CHU de Québec-Université Laval

• Pascal M. Lavoie, MD, PhD · University of British Columbia

• Andrew J. McPhee, MB, BS · South Australian Health and Medical Research Institute

• Carmel T. Collins, PhD · South Australian Health and Medical Research Institute

• David Simonyan, MSc · CHU de Québec-Université Laval

• Etienne Pronovost, BSc · CHU de Québec-Université Laval

• Mireille Guillot, MD · CHU de Québec-Université Laval

• Jacqueline F. Gould, PhD · South Australian Health and Medical Research Institute

• Ibrahim Mohamed, MD, PhD · St. Justine's Hospital

• Marc Beltempo, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

• Amélie Boutin, PhD · CHU de Québec-Université Laval

• Isabel Fortier, PhD · Research Institute of the McGill University Health Centre

• Thomas R. Sullivan, PhD · South Australian Health and Medical Research Institute

• Lynne Moore, PhD · Laval University

• Maria Makrides, PhD · South Australian Health and Medical Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Max Age

14 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-07-30

Primary Completion

2023-11-15

Completion

2026-03-31

Countries

• Canada

Study Locations