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临床试验/CTRI/2024/08/072630
CTRI/2024/08/072630尚未招募1/2 期

Targeted fortification of maternal breast milk to prevent postnatal growth failure in preterm infants : A randomised control trial

Jawaharlal Nehru Medical College KLE University Belagavi1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年8月31日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
To see the effect of targeted fortification of maternal breast milk in preventing post natal growth failure

研究概览

简要总结

Human breast milk is considered an ideal type of enteral nutrition among preterm neonates as the available evidence indicates both short-term and long-term benefits. However, for preterm infants, the amount of calories, macronutrients, electrolytes, minerals, and micronutrients provided by human breast milk (either maternal or donor breast milk) is insufficient to support and ensure appropriate postnatal growth that is on par with intra-uterine growth. Consequently, fortification of human breast milk with commercially available standard human milk fortifier is being undertaken to meet the deficit nutritional needs. Nevertheless, a significant proportion of preterm infants still do not achieve recommended postnatal growth velocity due to macronutrients and calorie insufficiency because of varied breast milk composition across the maternal population. Targeted fortification of maternal breast milk facilitates the optimization of of enteral nutritional intake through the measurement of the macronutrient and calorie content of native breast milk, adding standard human milk fortifier, and individually adjusting calorie, protein, and fat content with protein and fat human milk additives to reach ESPGHAN recommended daily requirements. Thus, the process may improve the postnatal growth velocity, facilitate proportionate growth, and minimize postnatal growth failure among preterm infants.

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 7.00 Day(s)(—)
性别
All

入选标准

  • Preterm infants less 32 6/7 weeks of gestation or less than 1250 grams.

排除标准

  • Congenital anomalies b.
  • Chromosomal abnormalities c.
  • GI surgical procedure/short bowel syndrome/ostomies d.
  • NPO status: NEC/feeding intolerance/inotrope dependent shock.

结局指标

主要结局

To see the effect of targeted fortification of maternal breast milk in preventing post natal growth failure

时间窗: To see the effect of targeted fortification of maternal breast milk in preventing post natal growth failure at the time of discharge and at 40 weeks

次要结局

  • To evaluate effects of targeted fortification on in hospital survival & anthropometric measures(Baby is assessed at the time of discharge & at 40 week post menstrual age)

研究者

发起方
Jawaharlal Nehru Medical College KLE University Belagavi
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Shireesha reddy vasantha

Jawaharlal Nehru Medical College,KLE University

研究点 (1)

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