A clinical trial to study the effect of expressed breast milk and direct breastfeeding in children with heart disease.
Not Applicable
Completed
- Conditions
- Health Condition 1: Q210- Ventricular septal defect
- Registration Number
- CTRI/2021/01/030713
- Lead Sponsor
- ABVIMS and Dr RML Hospital New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
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.
Exclusion Criteria
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 â?? malignancy ,neuromuscular, respiratory ,renal,
gastrointestinal, immunodeficiency and metabolic , genetic,or
other congenital anomaliesâ??.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight gain in grams during study period. <br/ ><br> <br/ ><br>Timepoint: Baseline, 2 weeks, 4 weeks <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Frequency of hospitalization during study periodTimepoint: at 2weeks, 4weeks