Starting Complementary Feeds in Preterms (The SCIP study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Weight
研究概览
简要总结
This is an open label randomised control trial comparing and evaluating the effect of early and delayed introduction of solid feeds on growth, haematological and biochemical markers in preterm infants. Preterm infants are more vulnerable to growth failure as they need to meet the nutrient losses accrued due to premature birth. They have higher energy and nutrient requirements than appropriate for gestational age infants and hence require enhanced nutritional support.
Some of the previous studies on preterm neonates concluded that early weaning will help in decreasing the caloric deficit and also improves the growth outcomes. It has also shown to improve the iron stores. Many mothers in our practice have started these feeds at 4-6 months of post natal age. However it is not concluded as to how early we can start these feeds.
In this RCT, the researchers want to look at two different ages for starting complementary feeds to improve the growth outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 3.00 Month(s) 至 1.00 Year(s)（—）
- 性别
- All
入选标准
- •Preterm infants born at Fernandez Hospital whose parents provide informed consent.
- •Preterm defined as infants born before 34 weeks period of gestation.
排除标准
- •Infants on solid feeds prior to 11 weeks corrected age and infants with diseases affecting growth and feeding; which includes those with a history of gastrointestinal disorders, congenital birth defects, bronchopulmonary disorders, congenital heart defects, chromosomal abnormalities and neurologic abnormalities.
结局指标
主要结局
Weight
时间窗: 1 year corrected age
次要结局
- Mid-upper arm circumference(1 year corrected age)
- Serum ferritin(1 year corrected age)
- Serum vitamin D(1 year corrected age)
- Serum calcium(1 year corrected age)
- Packed cell volume(1 year corrected age)
- Height(1 year corrected age)
- Hemoglobin(1 year corrected age)
- Occipito frontal circumference(1 year corrected age)
- History of eczema(1 year corrected age)
- Body mass index(1 year corrected age)