Effect of Early Fortification Versus Delayed Fortification of Human Milk on Anthropometric Parameters in Very Low birth Weight Infants: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Time to regain birth weight (in days) and subsequent rate of weight gain (gram/kg/day) at 4 weeks of postnatal age or discharge whichever is earlier
研究概览
简要总结
The current study aims to examine the effects of early fortification (initiating at 80 ml/kg/day) versus late fortification (initiating at 120 ml/kg/day) on the time taken to regain birth weight in preterm infants and weight gain velocity pattern following that along with head circumference and length increments. Understanding this could enhance nutritional protocols in the NICU, supporting the growth and development of this vulnerable population.
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
- •All inborn newborn admitted in NICU with Birth weight less than 1500 grams.
排除标准
- •Major congenital anomalies.
结局指标
主要结局
Time to regain birth weight (in days) and subsequent rate of weight gain (gram/kg/day) at 4 weeks of postnatal age or discharge whichever is earlier
时间窗: Time to regain birth weight (in days) and subsequent rate of weight gain (gram/kg/day) at 4 weeks of postnatal age or discharge whichever is earlier
次要结局
- increase in head circumference (cm/week) and length (cm/week) till discharge.(till discharge)
- Correlation between total protein intake and time to regain birth weight in days , weight(gain velocity , head circumference cm/ week, length cm /week.)
- Incidence of NEC stage 2 or more as per modified Bell’s stage.(till discharge)
- Feed intolerance incidence(till discharge)
- All cause mortality(In hospital)(till discharge)
- Incidence of extrauterine growth restriction at discharge (number of infants with weight <(10th percentile for the index population))
- Incidence of ROP requiring treatment(Till discharge)
- BPD incidence(till discharge)
研究者
Dr Sushil Kumar Choudhary
All India Institute of Medical sciences, Jodhpur