Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia (MOBYDIck)

Laval University

Status and phase: Active, not recruiting; Phase 3

Conditions: Neonatal and Perinatal Conditions; Child Development; Bronchopulmonary Dysplasia

Treatments: Combination Product: Placebo; Dietary Supplement: DHA-rich algal oil

Study type: Interventional

Funder types: Other

Identifiers

NCT02371460

MOP-136964 (Other Grant/Funding Number)

2015-2144, B14-09-2144-21

Details and patient eligibility

About

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.

Full description

Every year in Canada, 1500 babies who are born early (prematurely) develop a serious lung disease called bronchopulmonary dysplasia (BPD). BPD causes major health problems in these infants, especially in their early childhood. In most situations, breast-milk is the ideal source of nutrition for growth and development of premature babies. However, diets of Canadian mothers are generally deficient in omega-3 lipids (essential fats), resulting in lower protection from these omega-3 lipids in mother's milk-fed infants. Previous research has shown that giving DHA to mothers of premature babies is safe both for the mother and for their baby, and is an efficient way of helping babies meet their dietary requirements from breast-milk. Furthermore, this previous research also suggests that this intervention may reduce the risk of BPD in premature babies receiving breast-milk.

Enrollment: 800 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

MOTHERS

1. Mother is taking > 250 mg of daily DHA supplementation for last 3 months
2. 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)
3. Inability to comprehend and comply with study requirements
4. Participation in this study in a previous pregnancy

INFANTS

1. Significant congenital malformations in the infant (or one of the infants in case of multiple pregnancy)
2. 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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800 participants in 2 patient groups, including a placebo group

DHA-rich algal oil

Experimental group

Description:

1200mg DHA per day

Treatment:

Dietary Supplement: DHA-rich algal oil

Placebo

Placebo Comparator group

Description:

No supplementation in DHA

Treatment:

Combination Product: Placebo