Human Milk Fortifier Vs Preterm formula milk for fortification of Preterm Human Milk. A Non Inferiority Randomized Controlled Trial (PREMFORT STUDY)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Mean weight gain (g/kg/day)
研究概览
简要总结
This is a single center randomized open label non inferiority clinical trial comparing the effect of preterm formula and human milk fortifier for fortifying expressed breast milk in very low birth weight preterm infants less than 34 weeks gestation and less than 1500 grams. Infants receiving at least 100 mL per kg per day of expressed breast milk will be randomized into two groups. One group will receive preterm formula powder at 1 gram per 25 mL of expressed breast milk and the other group will receive commercial human milk fortifier at 1 gram per 25 mL. The primary outcome is mean weight gain in grams per kg per day until 40 weeks postmenstrual age or discharge. Secondary outcomes include weekly gain in length and head circumference and incidence of feed intolerance necrotizing enterocolitis late onset sepsis anemia requiring transfusion patent ductus arteriosus retinopathy of prematurity bronchopulmonary dysplasia and intraventricular hemorrhage. A total of 164 infants will be enrolled. Study duration is 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •Preterm neonates with gestational age less than 34 weeks, Birth weight less than 1500 grams (Very Low Birth Weight), Receiving at least 100 mL/kg/day of expressed breast milk at the time of enrollment, Written informed consent obtained from parent or legal guardian.
排除标准
- •Presence of major congenital anomalies, Neonates requiring surgery during NICU stay, Infants not receiving mother’s own milk or receiving less than 75% of feeds as expressed breast milk Neonates on mechanical ventilation at the time of enrollment.
结局指标
主要结局
Mean weight gain (g/kg/day)
时间窗: At 40 weeks postmenstrual age or discharge
次要结局
- Length gain (cm/week)(Weekly until discharge)
- Head circumference gain (cm/week)(Weekly until discharge)
- Feed intolerance(During hospital stay)
- Late onset sepsis(After 72 hours of life)
- Anemia requiring transfusion(During hospital stay)
- Hemodynamically significant PDA(During hospital stay)
- ROP requiring laser therapy(During hospital stay)
- Moderate to severe BPD(At 36 weeks postmenstrual age)
- IVH more than grade 2(During hospital stay)
研究者
Dr Ammar Haider
GMCH, Chhatrapati sambhajinagar