Comparison of short term weight gain in very low birth weight (VLBW) neonates receiving expressed breast milk (EBM) fortified with amino acid based powder formula vs conventional human milk fortifier: A randomized clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To compare the weight gain in gm/kg/day between the neonates receiving expressed breast milk fortified with amino acid based powder formula vs conventional human milk fortifier.
研究概览
简要总结
Human milk (HM) is considered as the gold standard for nutrition in preterm neonates.To meet the increased nutritional demands in preterm neonates, AAP recommends fortification of HM as the standard of care in preterm infants, less than 1500 g at birth.Several studies have shown that the in-hospital growth rates of preterm neonates who received fortified human breast milk with either human milk fortifiers or infant formula powder were better compared to the preterms who are fed with non-fortified breast milk.
In India, EBM in commonly fortified by using bovine based powdered HMF ( Lactodex HMF ). However, there are few concerns regarding the association of bovine based multicomponent fortifier with development of feed intolerance and NEC especially in very low birth weight neonates who are at a higher risk.
Currently, we are using Amino acid based powder formula as fortifier in VLBW infants with feed intolerance as it is non bovine based and better tolerated. Also, using Amino acid based formula powder as fortifier will be a more economical option.Hence we want to consider amino acid based formula powder as a primary fortifier and compare the growth patterns in VLBW infants receiving EBM fortified with amino acid based formula powder vs the conventional human milk fortifier and also assess the incidence of neonatal complications between both the groups.
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 99.00 Day(s)（—）
- 性别
- All
入选标准
- •Neonates who are born before 32weeks of gestational age and are having the following characteristics : a.Birth weight of less 1000gm b.Birth weight between 1000 to 1250gm and are having abnormal doppler studies antenatally or postnatally.
排除标准
- •Neonates with the following conditions will be excluded: a.
- •Major congenital malformation b.
- •Any gastrointestinal surgery prior to intervention.
结局指标
主要结局
To compare the weight gain in gm/kg/day between the neonates receiving expressed breast milk fortified with amino acid based powder formula vs conventional human milk fortifier.
时间窗: Everyday from the start of fortification (neonates reaching enteral feed of 120ml/kg/day) till discharge from the hospital.
次要结局
- Gain in length ( cm/week) between both the groups .(From the time of onset of fortification( neonates reaching enteral feed of 120ml/kg/day) till discharge from the hospital)
- Gain in head circumference(cm/week) between both the groups.(From the time of onset of fortification( neonates reaching enteral feed of 120ml/kg/day) till discharge from the hospital)
- Incidence of neonatal morbidities such as feed intolerance, necrotising enterocolitis , metabolic bone disease etc between both the groups.(From the time of onset of fortification( neonates reaching enteral feed of 120ml/kg/day) till discharge from the hospital.)
研究者
Dr Suvarna Sindhu Kodumuru
Fernandez Hospital