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临床试验/NCT03498989
NCT03498989Unknown不适用

Effect of Early Feeding of Breast Milk Versus Formula Milk on Health Status of Preterm

Assiut University0 个研究点目标入组 100 人开始时间: 2018年6月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
主要终点
Number of participants with complete blood pictures

研究概览

简要总结

Breast milk is an extremely complex and highly variable biofliud that has evolved to nourish infants and protect them from disease whilst their own immune system matures. The composition of human breast milk changes in response to many factors, matching the infants requirement according to its age and other characteristics.

详细描述

Breast milk is an extremely complex and highly variable biofliud that has evolved to nourish infants and protect them from disease whilst their own immune system matures. The composition of human breast milk changes in response to many factors, matching the infants requirement according to its age and other characteristics.

Therefore, the composition of breast milk is widely believed to be specifically tailored by each mother to precisely reflect the requirements of her infant.

Human milk is uniquely suited to the human infant, both in its nutritional composition and in the non-nutritive bioactive factors that promote survival and healthy development.

Breast milk contains over 400 different proteins which perform a variety of functions; providing nutrition, possessing antimicrobial and immunomodulatory activities, as well as stimulating the absorption of nutrients.

The immune system of preterm infants is immature, placing them at increased risk for serious immune-related complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
1 Week 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • Gestational age <37 weeks.
  • Birth weight >1000 gm.

排除标准

  • Gestational age 37 weeks.
  • Birth weight < 1000 gm.
  • Newborns with congenital anomalies.
  • Newborns with suspected metabolic diseases.
  • Newborns on mechanical ventilators.
  • Newborns with suspected neonatal sepsis.

研究组 & 干预措施

preterm formula milk neoborn

Experimental

will be given preterm formula milk

干预措施: preterm formula milk (Other)

exclusive breast milk

Experimental

will be given exclusive breast milk

干预措施: exclusive breast milk (Other)

结局指标

主要结局

Number of participants with complete blood pictures

时间窗: 1 year

All newborn are examine

Weight gain

时间窗: 1 year

All newborn well examine regards weight 1. Necrotizing enterocolitis. 2. Neonatal Sepsis. 3. Weight gain. 4. Feeding tolerance

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

AATaha

Paediatric

Assiut University

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