Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia
- Conditions
- Child DevelopmentNeonatal and Perinatal ConditionsBronchopulmonary Dysplasia
- Interventions
- Dietary Supplement: DHA-rich algal oilCombination Product: Placebo
- Registration Number
- NCT02371460
- Lead Sponsor
- CHU de Quebec-Universite Laval
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 800
- 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
MOTHERS
- 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
INFANTS
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DHA-rich algal oil DHA-rich algal oil 1200mg DHA per day Placebo Placebo No supplementation in DHA
- Primary Outcome Measures
Name Time Method BPD-free survival at 36 weeks PMA 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
- Secondary Outcome Measures
Name Time Method Mild, moderate and severe BPD at 36 weeks PMA Defined according to the severity-based National Institute of Child Health \& Development (NICHD) criteria
Any intraventricular hemorrhage and severe grade III or IV from randomization until discharge home or 40 weeks PMA According to Papile's classification; Screening is performed as routine care;
Sepsis until discharge home or 40 weeks PMA Defined as culture-positive (blood or cerebrospinal fluid) and/or clinical infection (with antibiotics ≥5 days)
Periventricular leucomalacia until discharge home or 40 weeks PMA Screening is performed as routine care
Bronchopulmonary Dysplasia (BPD) at 36 weeks PMA Physiological BPD is defined as the need for oxygen and/or ventilation at 36 weeks
Retinopathy of prematurity (any or threshold) until first discharge home or 40 weeks PMA According to the assessment by ophthalmologist, collected in the medical chart
Mortality until 36 weeks PMA Mortality is defined as death from any cause.
Necrotizing enterocolitis stage 2 or greater until first discharge home or 40 weeks PMA According to Bell criteria
Patent ductus arterious until first discharge home or 40 weeks PMA Requiring surgical ligation
Significant cholestasis until first discharge home or 36 weeks PMA Defined as conjugated serum bilirubin ≥34 µmol/L
Neuro-development at 18-22 months corrected age (CA) Defined as mean cognitive, language and motor composite scores of the Bayley Scale of Infant and Toddler Development's third edition (Bayley-III)
Child anthropometry until first discharge home or 36 weeks PMA Weight, length and cranial circumference as routinely measured and collected in the chart
Trial Locations
- Locations (16)
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Royal Alexander Hospital
🇨🇦Edmonton, Alberta, Canada
Royal Columbian Hospital
🇨🇦New Westminster, British Columbia, Canada
Children's and Women's Health Centre of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Victoria General Hospital
🇨🇦Victoria, British Columbia, Canada
St Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Kingston Health Science Centre
🇨🇦Kingston, Ontario, Canada
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
McGill University Health Center, Glen Site, Montreal Children's Hospital
🇨🇦Montreal, Quebec, Canada
CHU Sainte-Justine
🇨🇦Montréal, Quebec, Canada
Jewish General Centre
🇨🇦Montréal, Quebec, Canada
CHU de Québec-Université Laval, Centre Mère Enfant Soleil du CHUL
🇨🇦Québec, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada