Comparing the effect of early versus delayed fortification of human milk in neonates weighing less than 1600 grams on time to reach full feeds -A Randomized Controlled Trial
- Conditions
- Health Condition 1: E46- Unspecified protein-calorie malnutrition
- Registration Number
- CTRI/2024/04/065921
- Lead Sponsor
- ational Institute of Medical Science And Research , Jaipur , Rajasthan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Infants with birth weight (BW) =1600 g will be eligible for the study
2. Hemodynamically stable prior to randomization
3. Babies whose parents have given informed consent
Any one of the following
1. Antenatally diagnosed GI malformation
2. Baby born with absence or reversal of end-diastolic flow on antenatal umbilical artery Doppler
3. Presence of major congenital anomalies or chromosomal abnormalities at birth.
4. Need of two vasopressor support at the time of randomization for more than 48 hrs of life, due to which Human Milk Fortifier cannot be introduced by day 7
5. Perinatal asphyxia in neonates with APGAR score less than 4 at 5 min
6. Died or are expected to die within 72 hours.
7. Mother is not intended or is unable to provide the mother’s own milk
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the time taken to reach full feeds (150 ml/kg/day sustained for at least 24 hrs) in neonates with birth weight =1600 grams randomized based on the timing of initiation of fortification of feeds(60ml/kg/day vs 100 ml/kg/day)Timepoint: The subjects would be followed up till discharge or death
- Secondary Outcome Measures
Name Time Method To compare the outcome in terms of- <br/ ><br>1. Incidence of feed intolerance <br/ ><br>2. Incidence of NEC <br/ ><br>3. Incidence of sepsis <br/ ><br>4.Total duration of intravenous fluid usage <br/ ><br>5. Time of regaining birth weight <br/ ><br>6.Total duration of hospital stay <br/ ><br>7. Weight gain per kg per day at 1 month of age <br/ ><br>8. Extrauterine growth retardation (EUGR) at 36 weeks PMA or at discharge <br/ ><br>9. All-cause mortality <br/ ><br>10.Incidence of neonatal morbidities including ventilator days, postnatal steroid treatment, chronic lung disease, patent ductus arteriosus, severe intraventricular haemorrhage (grade III and IV), periventricular leukomalacia, and retinopathy of prematurity Timepoint: The subjects would be followed up till discharge or death