临床试验/CTRI/2025/03/082342

CTRI/2025/03/082342招募中4 期

Comparative efficacy of oral liposomal iron vs oral colloidal iron (standard care) in improving iron status in preterm infants of gestational age 30 to 34 weeks - A Double blind randomized controlled trial

Self1 个研究点分布在 1 个国家目标入组 80 人开始时间: 2025年4月15日最近更新: 2025年5月31日

试验速览

阶段: 4 期
状态: 招募中
发起方: Self
入组人数: 80
试验地点: 1
主要终点: To assess change in serum ferritin level

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This studies done to compared the efficacy of two oral iron formulations in preterm infants of gestational age 30 to 34 weeks based on serum ferritin levels A double blind randomised controlled trial

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 0.00 Day(s) 至 1.00 Month(s)（—）
性别: All

入选标准

•Preterm infants of gestational age 30-34 weeks On exclusive breast feeding On full enteral nutrition.

排除标准

•Preterm who had Blood transfusions Congenital gastrointestinal malformations Necrotising enterocolitis.

结局指标

主要结局

To assess change in serum ferritin level

时间窗: To assess change in serum ferritin level of baseline and at 4 weeks and 8 weeks after iron supplementation

次要结局

1.To assess increase in hemoglobin levels(2.Assess pattern of weight gain)

研究者

发起方

Self

申办方类型

Other []

责任方

Principal Investigator

主要研究者

S Nivetha

Madras medical college

研究点 (1)

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