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临床试验/NCT07667205
NCT07667205Enrolling By Invitation1 期

Liposomal Iron Versus Ferrous Iron Supplementation for Early Prophylaxis of Iron Deficiency Anemia in Preterm Neonates

Ain Shams University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月25日最近更新:

试验速览

阶段
1 期
状态
Enrolling By Invitation
入组人数
60
试验地点
1

研究概览

简要总结

Iron prophylaxis will be initiated at age of 2-3 weeks at a dose of 3mg/kg/day. Standard care group: will receive ferrous iron (Enrich oral drops(50mg/ml), one drop per kilogram of body weight daily.

Daily Liposomal group iron: will receive liposomal iron (Novofer (8mg/ml)) every day,seven drops per kilogram.

Every other day liposomal iron group: will receive liposomal iron (Novofer (8mg/ml)) every other day ,seven drops per kilogram .

详细描述

Iron prophylaxis will be initiated at age of 2-3 weeks at a dose of 3mg/kg/day. Standard care group: will receive ferrous iron (Enrich oral drops(50mg/ml), one drop per kilogram of body weight daily.

Daily Liposomal group iron: will receive liposomal iron (Novofer (8mg/ml)) every day,seven drops per kilogram.

Every other day liposomal iron group: will receive liposomal iron (Novofer (8mg/ml)) every other day ,seven drops per kilogram .

6. Administration of the iron thrapy:

  1. The bottle should be shaken well for at least 30 secend .
  2. The dose is better to administrated in the morning at least one hour before fed.

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 (Care Provider)

入排标准

年龄范围
2 Weeks 至 3 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm neonates Gestational age ≤ 34 weeks who can tolerate oral feeding.
  • Brith weight <2500gm.

排除标准

  • Major Surgical procedures.
  • Major Chromosomal anomaly.
  • Inborn error of metabolism.
  • GIT anomalies.
  • Neonatal sepsis.

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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