Active — Not RecruitingPhase 3

Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia

Canada800 participantsStarted 2015-06-23

Plain-language summary

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.

Who can participate

Age range16 Years

SexFEMALE

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Inclusion criteria

✓. Age more than or equal to 16 years
✓. Pre-term delivery (230/7- 286/7 weeks gestation)
✓. No contraindication to breastfeeding
✓. Subject intends to provide own breast milk to infant
✓. Randomization before or at 72 hours post delivery

Exclusion criteria

✕. Mother is taking \> 250 mg of daily DHA supplementation for 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)
✕. Inability to comprehend and comply with study requirements
✕. Participation in this study in a previous pregnancy
✕. Significant congenital malformations in the infant (or one of the infants in case of multiple pregnancy)
✕. Infant (or one of the infants in case of multiple pregnancy) who is currently enrolled in another clinical trial (unless approved by the Trial Coordinating Centre)

What they're measuring

BPD-free survival

Timeframe: at 36 weeks PMA

Trial details

NCT IDNCT02371460

SponsorCHU de Quebec-Universite Laval

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04-25

View on ClinicalTrials.gov More Bronchopulmonary Dysplasia trials