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临床试验/CTRI/2024/07/070683
CTRI/2024/07/070683招募中不适用

Human Milk Fortifier VS Preterm milk for fortification of Preterm Human Milk. A Non Inferiority Randomized Controlled Trial.

未提供1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2024年8月1日最近更新:

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:

  1. Preterm with major congenital anomalies

  2. Neonates not receiving preterm human milk (<75%).

  3. Preterm who is on Mechanical ventilation

  4. 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:

  1. To assess the head circumference and length

  2. 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

发起方
未提供
责任方
Principal Investigator
主要研究者

ammar haider

GMCH, aurangabad

研究点 (1)

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