Bronchopulmonary Dysplasia, Child Development, Neonatal and Perinatal Conditions
Conditions
Keywords
Neonatal Prematurity, Omega-3 Fatty Acids, Breastfeeding
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.
Interventions
DIETARY_SUPPLEMENTDHA-rich algal oil
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.
COMBINATION_PRODUCTPlacebo
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.
Sponsors
CHU de Quebec-Universite Laval
Canadian Institutes of Health Research (CIHR)
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Periventricular leucomalacia | until discharge home or 40 weeks PMA | 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) |
| 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 |
| 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 |
| 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; |
| 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) |
| Mortality | until 36 weeks PMA | Mortality is defined as death from any cause. |
| Bronchopulmonary Dysplasia (BPD) | at 36 weeks PMA | Physiological BPD is defined as the need for oxygen and/or ventilation at 36 weeks |
| Mild, moderate and severe BPD | at 36 weeks PMA | Defined according to the severity-based National Institute of Child Health \& Development (NICHD) criteria |
| Necrotizing enterocolitis stage 2 or greater | until first discharge home or 40 weeks PMA | According to Bell criteria |
| Child anthropometry | until first discharge home or 36 weeks PMA | Weight, length and cranial circumference as routinely measured and collected in the chart |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORIsabelle Marc, MD, PhD
CHU de Québec, Université Laval
PRINCIPAL_INVESTIGATORPascal Lavoie, MD, PhD
Children's and Women's Health Centre of BC, University of British Columbia
PRINCIPAL_INVESTIGATORBenoît Mâsse, PhD
CHU Sainte-Justine, Université de Montreal
PRINCIPAL_INVESTIGATORThierry Lacaze, MD, PhD
Children's Hospital of Eastern Ontario, University of Ottawa
PRINCIPAL_INVESTIGATORAnne-Monique Nuyt, MD, PhD
CHU Sainte-Justine, Université de Montreal
PRINCIPAL_INVESTIGATORWilliam Fraser, MD, MSc
Université de Sherbrooke
Outcome results
None listed