Effect of Human Milk Fortification Beyond Hospital Discharge on the Growth of Premature Infants
Phase 2
- Conditions
- Health Condition 1: P051- Newborn small for gestational ageHealth Condition 2: P071- Other low birth weight newbornHealth Condition 3: P073- Preterm [premature] newborn [other]
- Registration Number
- CTRI/2022/08/044831
- Lead Sponsor
- Shrutiprajna Kar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All preterm babies between 26 to 32 weeks gestation or birthweight less than 1500 grams with multi-nutrient milk fortification started during hospital stay
Exclusion Criteria
1. Neonates with major gastro-intestinal congenital malformations
2. Syndromic neonates assessed antenatally or postnatally
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the rate of weight gain (grams/kg/day) at 40 weeks P.M.A. in preterm (26-32 weeks gestation) or VLBW neonates (1500 grams) being continued on fortified breast milk beyond discharge with those who received unfortified breast milkTimepoint: Baseline and 40 weeks postmenstrual age
- Secondary Outcome Measures
Name Time Method To calculate cZ scores (change in Z score of weight, length & height from birth) at term equivalent according to modified Fentons growth charts <br/ ><br>Timepoint: Term equivalent age;To compare the rate of increase in head circumference (cm/week) from birth till term equivalent age <br/ ><br>Timepoint: Term equivalent age;To compare the rate of increase in length (cm/week) from birth till term equivalent age <br/ ><br>Timepoint: Term equivalent age;To estimate the percentage of Extrauterine growth restriction at 40 weeks P.M.A. <br/ ><br>Timepoint: Term equivalent age