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临床试验/CTRI/2021/01/030713
CTRI/2021/01/030713已完成不适用

Weight gain in babies with congenital heart disease and increased pulmonary blood flow :Breastfeeding versus supplemental spoon feeding. An open labelled randomized controlled trial

ABVIMS and Dr RML Hospital New Delhi1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年1月31日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Weight gain in grams during study period.

研究概览

简要总结

Infants with congenital heart disease and increased pulmonary blood flow frequently have feeding difficulty and failure to thrive. They typically present with interrupted feeding, sweating during feeds and suck rest suck cycle. Ideally all infants less than 6 months of age should be exclusively breastfed. Breastfeeding is a energy requiring process and is believed to be more tiring to the infants than spoon feeding. Keeping this in mind babies with heart disease and increased pulmonary blood flow are sometime advised to give expressed breastmilk by spoon so as to decrease energy expenditure. This has not been tested objectively yet and there is no evidence to support this practice. We want to find out whether feeding an infant with supplemental spoon feeding of expressed breastmilk will lead to better weight gain compared to traditional breastfed alone in infants with acyanotic congenital heart disease with increased pulmonary blood flow.

Hypothesis for study is that Supplemental feeding of expressed breastmilk by katori-spoon will lead to better weight gain compared to those on breastfeeding in infants with acyanotic congenital heart disease with increased pulmonary blood flow.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
1.00 Month(s) 至 5.00 Month(s)(—)
性别
All

入选标准

  • All infants with congenital heart disease with post tricuspid left to right shunt with modified Ross score > 6 On full breastfeeding Age at time of enrollment <5 months.

排除标准

  • Mother not available for breastfeeding .
  • Infants with obstructive cardiac left to right shunt & complex cardiac conditions.
  • Infants who have undergone any cardiac surgery.
  • Prematurity <37 weeks Known non-cardiac chronic conditions which are likely to affect growth including “ malignancy ,neuromuscular, respiratory ,renal, gastrointestinal, immunodeficiency and metabolic , genetic,or other congenital anomaliesâ€.

结局指标

主要结局

Weight gain in grams during study period.

时间窗: Baseline, 2 weeks, 4 weeks

次要结局

  • Frequency of hospitalization during study period(at 2weeks, 4weeks)

研究者

发起方
ABVIMS and Dr RML Hospital New Delhi
申办方类型
Research institution and hospital

研究点 (1)

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