Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Maternal Omega-3 Supplementation to Reduce BronchopulmonarY Dysplasia in Very Preterm Infants (MOBYDIck Trial)

Conditions
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Neonatal and Perinatal Conditions, Bronchopulmonary Dysplasia, Child Development

Intervention / Treatment
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* Dietary Supplement: DHA-rich algal oil
* Combination Product: Placebo


Participation Criteria
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Eligibility Criteria
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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: 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)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHA-rich algal oil<br>1200mg DHA per day | Dietary Supplement: DHA-rich algal oil<br>* 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.<br>* Other names: DHA group;|
| Placebo Comparator: Placebo<br>No supplementation in DHA | Combination Product: Placebo<br>* 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.<br>* Other names: Placebo group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at 36 weeks PMA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality is defined as death from any cause. | until 36 weeks PMA | 
| Bronchopulmonary Dysplasia (BPD) | Physiological BPD is defined as the need for oxygen and/or ventilation at 36 weeks | at 36 weeks PMA | 
| Mild, moderate and severe BPD | Defined according to the severity-based National Institute of Child Health & Development (NICHD) criteria | at 36 weeks PMA | 
| Necrotizing enterocolitis stage 2 or greater | According to Bell criteria | 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; | from randomization until discharge home or 40 weeks PMA | 
| Periventricular leucomalacia | Screening is performed as routine care | until discharge home or 40 weeks PMA | 
| Sepsis | Defined as culture-positive (blood or cerebrospinal fluid) and/or clinical infection (with antibiotics ≥5 days) | until discharge home or 40 weeks PMA | 
| Retinopathy of prematurity (any or threshold) | According to the assessment by ophthalmologist, collected in the medical chart | until first discharge home or 40 weeks PMA | 
| Patent ductus arterious | Requiring surgical ligation | until first discharge home or 40 weeks PMA | 
| Significant cholestasis | Defined as conjugated serum bilirubin ≥34 µmol/L | until first discharge home or 36 weeks PMA | 
| Child anthropometry | Weight, length and cranial circumference as routinely measured and collected in the chart | until first discharge home or 36 weeks PMA | 
| Neuro-development | Defined as mean cognitive, language and motor composite scores of the Bayley Scale of Infant and Toddler Development's third edition (Bayley-III) | at 18-22 months corrected age (CA) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal Prematurity, Omega-3 Fatty Acids, Breastfeeding