Health Condition 1: E46- Unspecified protein-calorie malnutrition
Conditions
Interventions
Intervention1: Early: Babies will be started on exclusive breastmilk within the first 7 days of life at 20ml/kg/day once hemodynamically stabilised. Feeds will be increased by 20 ml/kg/day till baby
Sponsors
National Institute of Medical Science And Research , Jaipur , Rajasthan
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To compare the outcome in terms of- 1. Incidence of feed intolerance 2. Incidence of NEC 3. Incidence of sepsis 4.Total duration of intravenous fluid usage 5. Time of regaining birth weight 6.Total duration of hospital stay 7. Weight gain per kg per day at 1 month of age 8. Extrauterine growth retardation (EUGR) at 36 weeks PMA or at discharge 9. All-cause mortality 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 | — |
Countries
India
Contacts
Public ContactGunjana kumar
National Institute of Medical Science and Research, Jaipur,Rajasthan
Outcome results
None listed