Breastmilk fortification with human milk derived human milk fortifier-RCT
Not Applicable
- Conditions
- Health Condition 1: P788- Other specified perinatal digestive system disorders
- Registration Number
- CTRI/2023/01/048975
- Lead Sponsor
- Department of Neonatology KEM Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Preterm infants born at or before 30 weeks of gestation with birth weight less than 1000 g. and receiving 100 mL kg per day of enteral human milk feeds
Exclusion Criteria
Major congenital anomaly
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of in-hospital weight gain measured as gram per kilogram per day from the day of initiating fortificationTimepoint: day of discharge or 40 weeksâ?? PMA, whichever is earlier.
- Secondary Outcome Measures
Name Time Method Time to reach full feeds: a feed volume of 150ml/kg/day <br/ ><br>Rate of in-hospital length and head circumference growth measured as cm per day from the day of initiating fortification <br/ ><br>Incidence of feed intolerance <br/ ><br>Incidence of Necrotizing enterocolitis (NEC) <br/ ><br>Incidence of late onset sepsis <br/ ><br>Incidence of Extrauterine growth restriction (EUGR) <br/ ><br>Mortality <br/ ><br> <br/ ><br>Timepoint: to the day of discharge or 40 weeksâ?? PMA, whichever is earlier