Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia

Phase 3Active Not RecruitingNCT02371460

CHU de Quebec-Universite Laval800 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

800

Conditions

Bronchopulmonary Dysplasia Child Development Neonatal and Perinatal Conditions

Interventions

DHA-rich algal oilDIETARY_SUPPLEMENT

Mothers will receive a DHA-rich algal oil treatment (400 mg DHA per capsule) three times a day before meals from randomization (\<72 hours post-delivery) until the infant reaches 36 weeks PMA.

PlaceboCOMBINATION_PRODUCT

Mothers will receive a placebo capsule three times a day before meals from randomization (\<72 hours post-delivery) until the infant reaches 36 weeks PMA.

Eligibility

Sex: FEMALEMin age: 16 Years

Medical Language ↔ Plain English

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)

Locations (16)

Foothills Medical Centre

Calgary, Alberta, Canada

Royal Alexander Hospital

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

BPD-free survival

Defined as (1- combined rate of mortality and BPD in survivors). Mortality is defined as death from any cause between randomization and 36 weeks PMA. Physiological BPD is defined as the need for oxygen and/or ventilation at 36 weeks

Time frame: at 36 weeks PMA

Secondary Outcomes

Mortality

Mortality is defined as death from any cause.

Time frame: until 36 weeks PMA

Bronchopulmonary Dysplasia (BPD)

Physiological BPD is defined as the need for oxygen and/or ventilation at 36 weeks

Time frame: at 36 weeks PMA

Mild, moderate and severe BPD

Defined according to the severity-based National Institute of Child Health \& Development (NICHD) criteria

Time frame: at 36 weeks PMA

Necrotizing enterocolitis stage 2 or greater

According to Bell criteria

Time frame: until first discharge home or 40 weeks PMA

Any intraventricular hemorrhage and severe grade III or IV

According to Papile's classification; Screening is performed as routine care;

Time frame: from randomization until discharge home or 40 weeks PMA

Periventricular leucomalacia

Screening is performed as routine care

Time frame: until discharge home or 40 weeks PMA

Sepsis

Defined as culture-positive (blood or cerebrospinal fluid) and/or clinical infection (with antibiotics ≥5 days)

Data from ClinicalTrials.gov

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