Maternal Omega-3 Supplementation to Reduce BronchopulmonarY Dysplasia in Very Preterm Infants (MOBYDIck Trial)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 461
- 试验地点
- 16
- 主要终点
- BPD-free survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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)
研究组 & 干预措施
DHA-rich algal oil
1200mg DHA per day
干预措施: DHA-rich algal oil (Dietary Supplement)
Placebo
No supplementation in DHA
干预措施: Placebo (Combination Product)
结局指标
主要结局
BPD-free survival
时间窗: 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
次要结局
- Mild, moderate and severe BPD(at 36 weeks PMA)
- Periventricular leucomalacia(until discharge home or 40 weeks PMA)
- Mortality(until 36 weeks PMA)
- Child anthropometry(until first discharge home or 36 weeks PMA)
- Any intraventricular hemorrhage and severe grade III or IV(from randomization until discharge home or 40 weeks PMA)
- Sepsis(until discharge home or 40 weeks PMA)
- Bronchopulmonary Dysplasia (BPD)(at 36 weeks PMA)
- Retinopathy of prematurity (any or threshold)(until first discharge home or 40 weeks PMA)
- Necrotizing enterocolitis stage 2 or greater(until first discharge home or 40 weeks PMA)
- Patent ductus arterious(until first discharge home or 40 weeks PMA)
- Significant cholestasis(until first discharge home or 36 weeks PMA)
- Neuro-development(at 18-22 months corrected age (CA))