Health Condition 1: P073- Preterm [premature] newborn [other]
Conditions
Interventions
Intervention1: Rapid advancement of feeds at 30 ml/kg/day: Early total enteral feeds started at 80 mL/kg/day, then increased by 30 mL/kg/day until 150 mL/kg/day is achieved and sustained for 24 hours.
Sponsors
NICUAIIMS Bhubaneswar
Eligibility
Inclusion criteria
Inclusion criteria: Preterm neonates born between 28 and 34 weeks of gestation and classified as small for gestational age, eligible to start on early total enteral feeds
Exclusion criteria
Exclusion criteria: Babies in whom Early total enteral feeding is not possible, as in 1. Perinatal asphyxia 2. Hemodynamic instability 3. Major congenital malformations precluding enteral feeding 4. Multiple organ dysfunction or need for emergency surgery 5. Reversal of end diastolic flow and Parental refusal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to achieve full enteral feeding, defined as the time in days taken to achieve and maintain 150 mL/kg/day of feeds for 24 hours.Timepoint: Assessed daily from randomization or enrollment until full enteral feeding (150 mL/kg/day sustained for 24 hours) is achieved, which is expected in 4 days in the intervention arm and 5 days in the comparator arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate predictive performance of NIRS derived early splanchnic oxygenation parameters in determining feed intoleranceTimepoint: During the first 72 hours after randomisation or initiation of feeds, that is baseline, 24 hours after initiation of feeds, 48 hours after initiation of feeds, 72 hours after initiation of feeds;To compare the incidence of feed intolerance & necrotizing enterocolitisTimepoint: On Day 7, Day 14, & at discharge;To compare growth recovery by comparing time to regain birth weightTimepoint: Assessed daily, outcome recorded as number of days to regain birth weight;To assess hospitalisation burden by assessing length of hospital stayTimepoint: Measured at discharge;To evaluate infection burden by assessing culture proven sepsisTimepoint: During hospitalisation, outcome recorded as incidence upto discharge. | — |
Countries
India
Contacts
Public ContactJagdish Prasad Sahoo
All India Institute of Medical Sciences, Bhubaneswar
Outcome results
None listed