Renoir: A Randomised, Double-blind, Controlled Trial to Evaluate the Effects of a New Human Milk Fortifier on Growth and Tolerance in Preterm Infants.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 15
- 主要终点
- Weight growth velocity
研究概览
简要总结
Preterm birth (birth before start of the 37th week of gestation) is a major determinant of neonatal morbidity and mortality and has long-term adverse consequences for health and neurodevelopment.
Preterm infants have much higher nutrient requirements than term infants. The preferred nutrition for all infants including preterm infants is human milk from the infant's own mother, or alternatively donor human milk, provided it is fortified with several nutrients as human milk alone does not sufficiently meet the nutritional needs of preterm infants.
Human milk fortifiers (HMFs) are multicomponent enrichments that can be added to human milk (own mother´s milk or donor milk) to meet the increased nutritional needs of preterm infants. The current Nutricia HMF (control product) has been available in its current composition since 2010. It is a multicomponent HMF providing protein, energy, minerals, and vitamins in accordance with the ESPGHAN recommendations.
Recent investigation suggests positive effects on growth and development of preterm infants when lipids are added to their nutrition. Therefore, Nutricia has added lipids to their HMF (test product) for a nutritionally more complete fortification of human milk aiming for optimal growth and optimal cognitive and brain development.
The Renoir study will investigate the difference between both HMFs with regards to the growth velocity as well as the safety and tolerance of the new HMF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Week 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants fed own mother's milk (or donor human milk) in need of a HMF (as decided by the investigator)
- •Gestational age <32 weeks and birth weight <1500 g
- •Receiving enteral feeding
- •Expected to need a HMF for minimally 21 days
- •Written informed consent from custodial parent(s)
排除标准
- •Any relevant proven or suspected chromosomal anomaly, metabolic disorder, genetic syndrome or congenital central nervous system malformation;
- •Presence or history of any gastrointestinal malformation, including Necrotising enterocolitis (NEC) (defined as Bell's stage two or higher);
- •No realistic prospect of survival at the discretion of the attending physician;
- •Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study;
- •Expected or foreseen inability of the subject and/or their families to adhere to protocol instructions.
结局指标
主要结局
Weight growth velocity
时间窗: 21 days
Weight growth velocity (in g/kg/day) from baseline to study day 21
次要结局
- Z-scores(up to 16 weeks, depending on gestational age at birth)
- Stool consistency(up to 16 weeks, depending on gestational age at birth)
- Stool frequency(up to 16 weeks, depending on gestational age at birth)
- Enteral intake(up to 16 weeks, depending on gestational age at birth)
- vomiting(up to 16 weeks, depending on gestational age at birth)
- Regurgitation(up to 16 weeks, depending on gestational age at birth)
- Enteral feed(up to 16 weeks, depending on gestational age at birth.)
- Length(up to 16 weeks, depending on gestational age at birth)
- Head circumference(up to 16 weeks, depending on gestational age at birth)
- Weight for Length(up to 16 weeks, depending on gestational age at birth)