Comparison of efficacy of amino acid based human milk fortifier versus bovine milk derived human milk fortifier in very low birth weight neonates: A single Centre open label randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Rate of weight gain (g/kg/day) till 1800 grams of weight achieved.
研究概览
简要总结
Background- Nutritional requirements especially protein requirement in very low birth weight preterm babies is higher than their term counterparts. Human milk fortification has been done to increase the protein content of mother’s own milk and thus to enhance growth of the babies. Till now, only bovine milk based human milk fortifiers (BM-HMF) with protein content of (0.27-0.3g/ 1g sachet) were available in India, recently amino acid based human milk fortifier (AA-HMF) with higher protein content (0.35g/1g sachet) is made available. Only few studies done in India where it has shown that amino acid based fortifier is well tolerated. Extra calories and protein content in amino acid based fortifier may lead to better weight gain compare to existing practice.
Current practice of adding BM-HMF has proven efficacy but issues with gastrointestinal intolerance. Fortification with AA-HMF has been demonstrated to be safe in VLBW neonates. Amino acid based human milk fortifier has shown benefits in terms of the improved weight gain, reducing overall morbidity in VLBW neonates.
Our study is being planned with the aim to compare effectiveness of AA-HMF compare to existing standard practice of adding BM-HMF in human milk to increase caloric and nutritional value.
Methods: Trial will be done on very low birth weight neonates (500 to <1500grams) admitted in neonatal intensive care unit. Eligibility assessment will be done followed by stratification based on the birth weight (500g- 999grams and 1000-1499grams). These babies will be randomized to the comparator and intervention group, when they satisfy the inclusion criteria.
Comparator group- Babies will receive bovine milk derived – human milk fortifier (BM-HMF) as per the current standard practice.
Intervention group- Babies will receive amino acid based- human milk fortifier (AA-HMF).
Babies will be monitored for weight gain, other anthropometric parameters like length and head circumference and laboratory parameters as per the existing neonatal intensive care unit protocol.
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
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •1.Babies with birth weight 500 to ≤1500 grams (Explanation-when baby fulfill 1st criterion then baby will receive following routine care) Step 1- An intravenous glucose infusion/TPN/PPN 80 mL/kg/day will be started during the first hours of life.
- •Step 2- Progressive enteral feeding with initial volume of 30 ml/kg/day will be started in babies as per mother’s own milk availability as per unit protocol 2.Babies with milk intake of at least 100 ml/kg/day.
- •(Explanation: when baby reach feed volume of 100 ml/kg/day-fortification will be started) 3.Maternal intent to provide breast milk.
- •(Explanation: Fortification is only for the breast milk).
排除标准
- •1.Parents and guardians unwilling to provide consent for the study.
- •2.Major congenital malformation.
- •3.Necrotising enterocolitis.
- •4.Complete unavailability of mother’s own milk.
- •5.Mother’s milk is contraindicated.
结局指标
主要结局
Rate of weight gain (g/kg/day) till 1800 grams of weight achieved.
时间窗: Daily weight will be checked till baby attain 1800 gram weight
次要结局
- 1. Time taken to reach weight of 1800 grams (days)(2. Length gain (cm/week) till 1800 grams.)
研究者
Dr Nishant Banait
All India Institute of Medical Sciences Nagpur