Comparison of Mothers milk with formula against Mothers milk with fortifier for growth of the baby.
Phase 3
- Registration Number
- CTRI/2021/10/037446
- Lead Sponsor
- Shree Krishna Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All pre-term newborns (maturity < 37 weeks) and birth weight in a category of very low birth weight
(1000 gm to 1499 gm) during the study period will be eligible for participation in the study.
Exclusion Criteria
Any newborn infant who had
1) major congenital malformation
2) necrotizing enterocolitis (NEC) stage 2 or stage 3,
3)not reaching full volume feeds by day 21 of life
4) parental lack of consent
5) Frequent feed intolerance on mothersâ?? milk during first 14 days of life.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of velocity of gain in weight.Timepoint: Total 1-year duration, 10 months for sample collection, 1 month for statistical analysis, 1 month for manuscript writing.
- Secondary Outcome Measures
Name Time Method length, Head circumference, duration of hospital stay, comorbidities like Necrotising Enterocolitis, and feed intolerance.Timepoint: Total 1-year duration, 10 months for samples collection, 1 month for statistical analysis, 1 month for manuscript writing