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临床试验/NCT05242107
NCT05242107已完成不适用

Role of Omega-3 Supplementation on Lipid Profile and Serum Leptin Level in Neonates With Intrauterine Growth Restriction

Tanta University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Level of serum leptin

研究概览

简要总结

The aim of our study will demonstrate the effect of omega 3 supplementation on serum lipid profile level and leptin level in neonates with Intrauterine Growth Restriction( IUGR)

详细描述

Intrauterine growth restriction is a major cause of perinatal mortality and morbidity .

It is noted to affect approximately 5-15 % of pregnant women. Egypt has one of the highest incidences of Intrauterine Growth Restriction. The incidence of IUGR varies among countries, populations, races and increases with decreasing gestational age. 14 to 20 million infants have been affected with Intrauterine Growth Restriction cases in the developing countries annually.

A complex and dynamic interaction of maternal, placental and fetal environment is involved in ensuring normal fetal growth. An imbalance or lack of coordination in this complex system may lead to Intrauterine Growth Restriction. Intrauterine Growth Restriction( IUGR) results in significant perinatal and long-term complications, including increased neonatal mortality and morbidity and higher risk for developing metabolic syndrome later in life.

Physiological differences have been noted in growth restricted infants. Intrauterine amino acid disturbances similar to biochemical changes seen in postnatal protein deprived states have been detected. Protein metabolism defect and altered lipid metabolism also have been described.

Undernourishment in utero appears to be associated with persisting changes in the metabolic functions. Birth weight influences the lipoprotein profile and cholesteryl ester transfer protein, which promotes a proatherogenic lipoprotein profile in plasma by determining chemical, physical and biological properties of the respective lipoprotein particle in neonates.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Day 至 4 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Any full-term Intrauterine growth restriction (IUGR) neonate

排除标准

  • Preterm neonates
  • Who died before feeding was established
  • Multiple congenital anomalies including GIT anomalies
  • Congenital infection
  • Cholestasis
  • Infant of diabetic mother (IDM)

结局指标

主要结局

Level of serum leptin

时间窗: 4 weeks from admission to neonatal intensive care unit

Effect of omega 3 (Docosa-hexa-enoic acid (DHA) 40 mg/kg/ day)supplementation on level of serum leptin in neonates with Intrauterine growth restriction (IUGR).

次要结局

  • Level of serum lipid(4 weeks from admission to neonatal intensive care unit)

研究者

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

Mai Rabie El-Sheikh

Doctor

Tanta University

研究点 (1)

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