跳至主要内容
临床试验/CTRI/2025/03/083204
CTRI/2025/03/083204尚未招募不适用

Systematic study if breastfeeding practices in infants with Congenital Heart Diseases (CHD) and effectiveness of implementation of tailored interventions to improve breastfeeding outcomes- A Prospective Interventional Study

Pediatric Cardiac Society of India PCSI1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年4月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
1. Time to restart feeds after cardiac surgery

研究概览

简要总结

This prospective interventional study aims to improve breastfeeding outcomes in infants with congenital heart disease (CHD) undergoing cardiac surgery by implementing targeted interventions such as maternal education and structured lactation counseling.

Building on prior research phases that identified breastfeeding challenges, this study systematically applies tailored interventions to all mother-infant dyads recruited in the study. These interventions include personalized lactation support, educational materials in local languages, and trained lactation counselors guiding mothers through the perioperative period.

The study follows up with key outcome measures such as:

  • Time to establish full oral feeds postoperatively
  • Proportion of mothers breastfeeding at discharge
  • Infant weight gain trends

By addressing modifiable barriers and optimizing lactation support, this study aims to establish a model of care that enhances breastfeeding success and nutritional outcomes in CHD infants

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
1.00 Day(s) 至 1.00 Year(s)(—)
性别
All

入选标准

  • Infants and neonates, born at term gestation diagnosed with Congenital heart disease, planned for corrective or palliative surgery.
  • Infants with mothers who are willing to breastfeed.

排除标准

  • 未提供

结局指标

主要结局

1. Time to restart feeds after cardiac surgery

时间窗: 1. Baseline- at the time of Admission | 2. Immediate postop | 3. At the time of discharge | 4. 1 month follow up

2. Percentage of mothers directly breastfeeding at discharge

时间窗: 1. Baseline- at the time of Admission | 2. Immediate postop | 3. At the time of discharge | 4. 1 month follow up

3. Infant weight at admission, discharge and 1 month follow up

时间窗: 1. Baseline- at the time of Admission | 2. Immediate postop | 3. At the time of discharge | 4. 1 month follow up

次要结局

  • Infant weight at admission, discharge and 1 month follow up(admission, discharge and 1 month follow up)

研究者

发起方
Pediatric Cardiac Society of India PCSI
申办方类型
Research institution

研究点 (1)

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