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临床试验/NCT04317638
NCT04317638Unknown不适用

Lipid Profile of Full-term Infants on Different Feeding Regimen: a Comparative Study

Assiut University0 个研究点目标入组 300 人开始时间: 2021年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
主要终点
comparison between lipid profiles of the infants of the 3 groups

研究概览

简要总结

Lipid profile of full-term infants on different regimens. The aim of the study is to compare infant's lipid profiles on different feeding regimen during the first 6 months of life and its correlation with their mothers' lipid profiles (exclusive breastfeeding and mixed feeding) and to compare infants' lipid profiles on different feeding regimen with each other (including those on exclusive formula feeding).

详细描述

Infant and young child feeding is critical for their health and survival. Based on well-established evidence, the World Health Organization (WHO) and the United Nations Children's fund (UNICEF) recommend that mothers put newborns to the breast within one hour of birth, breastfeed infants exclusively for the first six months and continue to breastfeed for two years and beyond, together with nutritionally adequate, safe, age-appropriate, responsive feeding of solid, semi-solid and soft food starting in the sixth month.

For the first six months of life, breast milk alone is the ideal nourishment, providing all of the nutrients including minerals and fat soluble vitamins, an infant needs, meaning that no other liquid or food is needed.

In addition to providing a generally adequate nutrient supply that support normal growth and development , breastfeeding has been linked to multiple other advantages including a reduced risk of infection and long-term benefits for the risk of obesity, type II diabetes mellitus, blood pressure and better performance in intelligence tests.

The macro-nutrient composition of human milk varies within mothers according to nutritional status and across lactation. The mean macro-nutrient composition of mature, term milk is estimated to be approximately 0.9 to 1.2 gm/dl for proteins, 3.2 to 3.6 gm/dl for fats and 6.7 to 7.8 gm/dl for lactose.

There have been several systematic reviews supporting the positive effects of breastfeeding on cardiovascular risk factors, such as obesity and type 2 diabetes (DMII), hypertension. Breastfeeding also reduces plasma levels of total cholesterol (TC) and low density lipoprotein (LDL).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
12 Weeks 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Apparently healthy infants during the first 6 months of life on different feeding regimen

排除标准

  • Infants with perinatal problems .e.g.,
  • birth asphyxia
  • premature rupture of membranes
  • hypoglycemia
  • hypothermia
  • meconium stained amniotic fluid
  • pathological jaundice
  • congenital malformations
  • clinical evidence of chromosomal abnormalities
  • Infants born to mothers having any chronic disease e.g.,
  • diabetes mellitus
  • gestational diabetes
  • hypertension
  • pre-eclampsia
  • eclampsia
  • hypo/hyperthyroidism
  • on any long-term medication

结局指标

主要结局

comparison between lipid profiles of the infants of the 3 groups

时间窗: baseline

analysis of the results of lipid profiles of infants on different feeding regimens at the age of 14 weeks and 6 months

correlation of lipid profiles of infants and their mothers

时间窗: baseline

analysis of the results of lipid profiles of infants on exclusive breast feeding and mixed feeding (breast and formula feeding) and the results of lipid profiles of their mothers

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

Maria Remon Riad Sedrak

Doctor

Assiut University

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