Human Milk Fortifier VS Preterm milk for fortification of Preterm Human Milk. A Non Inferiority Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- To know the efficacy of fortifying preterm human milk
研究概览
简要总结
Human Milk Fortifier VS Preterm milk for fortification of Preterm Human Milk. A Non Inferiority Randomized Controlled Trial.
Primary objective:
To know the efficacy of fortifying preterm human milk
with Preterm Formula Milk and Human Milk Fortifier in
terms of time achieved to attain birth weight.
Secondary objectives:
To assess the head circumference and length
To assess the complications like feed intolerance,
necrotizing enterocolitis.
Inclusion Criteria:
Preterm infants with a gestational age less than 34
weeks admitted to the neonatal intensive care unit
(NICU).
Receiving EBM of 100ml/kg/day.
Give consent to be included in the study.
Exclusion Criteria:
-
Preterm with major congenital anomalies
-
Neonates not receiving preterm human milk (<75%).
-
Preterm who is on Mechanical ventilation
-
Neonates requiring surgery.
PRIMARY OBJECTIVES:
To know the efficacy of fortifying preterm human milk with Preterm Formula Milk
and Human Milk Fortifier in terms of time achieved to attain birth weight.
2.2 : SECONDARY OBJECTIVES:
-
To assess the head circumference and length
-
To assess the complications like feed intolerance, necrotizing enterocolitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
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 infants with a gestational age less than 34 weeks admitted to the neonatal intensive care unit (NICU).
- •Receiving EBM of 100ml/kg/day.
- •Give consent to be included in the study.
排除标准
- •Preterm with major congenital anomalies Neonates not receiving preterm human milk (LESS THAN 75%).
- •Preterm who is on Mechanical ventilation Neonates requiring surgery.
结局指标
主要结局
To know the efficacy of fortifying preterm human milk
时间窗: Till discharge
with Preterm Formula Milk and Human Milk Fortifier in
时间窗: Till discharge
terms of time achieved to attain birth weight.
时间窗: Till discharge
次要结局
- To assess the head circumference and length(To assess the complications like feed intolerance,)
研究者
ammar haider
GMCH, aurangabad
