Optimizing Mothers' Milk for Preterm Infants (OptiMoM) Program of Research: Study 2-Bovine vs. Human Milk-Based Fortifier Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 18
- 主要终点
- Feeding tolerance
研究概览
简要总结
Most very low birth weight infants accumulate a nutrient deficit in hospital due to minimal nutrient reserves and elevated nutritional requirements which may contribute to poor outcome. Adding nutrients to human milk improves their nutritional status and growth, but it is unclear if adding bovine protein-based fortifiers as is the current standard of care has some unintended negative consequences to neonates. Infants will be randomized to have their feeds (mother's own milk or pasteurized donor breastmilk) nutrient enriched with a human milk-based fortifier or a bovine protein-based fortifier and will be followed in hospital to assess feeding tolerance, growth, gut inflammation, mother's milk and infant gut microbiome, and neonatal morbidity and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<1250g birth weight
- •Parent(s) or guardian(s) agree to use donor breastmilk if own mother's milk supply is insufficient
排除标准
- •Infant receives formula or a nutrient fortifier prior to randomization
- •>day 14 at the time of enrollment and enteral feeds have not commenced
- •Infants with major congenital or chromosomal anomalies that could impact growth
- •Enrollment in another research study affecting nutritional management during the feeding intervention
- •Reasonable potential that the infant will be transferred to a neonatal intensive care unit where the study protocol will not be continued
研究组 & 干预措施
Bovine protein-based fortifier
干预措施: Bovine protein-based fortifier (Other)
Human milk-based fortifier
干预措施: Human milk-based fortifier (Other)
结局指标
主要结局
Feeding tolerance
时间窗: 84 days of age, hospital discharge or when able to consume two oral feeds a day without supplementation (e.g. tube feeding), whichever comes first
Percentage of infants with a significant feeding interruption as defined by days feedings held for ≥12 hours OR feeds reduced by \>50% (ml/kg/d) not due to a clinical procedure or transitioning to the breast
次要结局
- Growth(84 days of age, hospital discharge or when able to consume two oral feeds a day without supplementation (e.g. tube feeding), whichever comes first)
研究者
Deborah O'Connor
Senior Associate Scientist, Research Institute
The Hospital for Sick Children