Effect of Extensively Hydrolyzed Liquid Human Milk Fortifier on Growth and Tolerance in Moderately Premature Infants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Cumulative weight gain
研究概览
简要总结
The purpose of this study is for the researchers to examine the safety and efficacy of liquid human milk fortifier (HMF) in moderately preterm infants compared to powdered human milk fortifier.
详细描述
This is a prospective, randomize, double-blinded study in preterm infants born between 28-34 weeks gestation admitted to the NICU at the University of Kansas Hospital. After obtaining informed consent, babies will be randomized to either liquid or powdered HMF using opaque, sealed envelopes with preassigned randomization. The feeding protocol as established in the KU NICU will be followed, beginning with initiation of trophic feeds, and advancement of enteral feeds depending on the gestational age and preceding illnesses. Once infants reach 80ml/kg/day of enteral feeds, human milk will be fortified to 22 kilocalories by adding either liquid or powdered fortifier. The beginning of the study(Study day 1) will be defined as reaching and tolerating 100ml/kg/day of 24 kilocalorie human milk fortified with either liquid or powdered fortifier. Enteral feeds will be advanced per unit protocol until they reach 150-160ml/kg/day and 110-120 kcal/kg/day. the volume of feeds will be adjusted based on the documented weight to provide energy and protein requirements as recommended by the ESPGHAN guidelines. Babies will be followed up until the time of NICU discharge.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 28 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inborn preterm infants born between 28 0/7 and 34 0/7 weeks gestation and fed either mother's own milk or donor human milk
排除标准
- •Newborn infants <28 weeks and >34 weeks gestation, those with life threatening illness, congenital and chromosomal anomalies, gastrointestinal anomalies or necrotizing enterocolitis and fed premature formula
结局指标
主要结局
Cumulative weight gain
时间窗: Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier
Weight gain of baby during the course of the study
Change in weight
时间窗: Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier
Weight gain of baby week-to-week, during the course of the study
Linear length
时间窗: Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier
change in length week-to-week during the course of the study
Head growth
时间窗: Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier
Change in head measurements week-to-week during the course of the study
次要结局
- Nutrition biomarkers(Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier)
- Tolerance to enteral feeds(Baseline to 36 Weeks post-conceptional age or Study Day 28, whichever is earlier)