Comparison of supplementation of preterm versus term donor pooled human milk on growth of very low birth weight neonates
Phase 3
Completed
- Conditions
- Health Condition 1: P76-P78- Digestive system disorders of newborn
- Registration Number
- CTRI/2020/02/023569
- Lead Sponsor
- Government Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 102
Inclusion Criteria
Very low birth babies (birth weight <1500 grams)
Exclusion Criteria
1. Babies born with major congenital malformation
2. Babies who had already developed NEC IIa or above before enrollment
3. Babies born to retrovirus positive mother
4. Babies born at gestation <27 weeks or birth weight <800 grams
5. Galactosemia or other contraindication to human milk
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Days to regain birth weight in VLBW babies received pooled preterm DHM and pooled term DHMTimepoint: At discharge or at 40 weeks post menstrual age
- Secondary Outcome Measures
Name Time Method Duration of parenteral nutrition use (days)Timepoint: Till discharge;Episodes of feeding intoleranceTimepoint: Till discharge;Incidence of necrotising enterocolitis IIa or moreTimepoint: Till discharge;Rate of head circumference gain in cm/weekTimepoint: At discharge or at 40 weeks post menstrual age;Rate of length gain in cm/weekTimepoint: At discharge or at 40 weeks post menstrual age;Rate of weight gain in gm/kg/dayTimepoint: At discharge or at 40 weeks post menstrual age;Time to achieve full feed (day-1 of 120 ml/kg/day if tolerate for 3 consecutive days)Timepoint: Time to achieve full feed;Z Score of weight, height and head circumferenceTimepoint: At 40 weeks of post menstrual age