Early Total Enteral Feeding Versus Convention Enteral Feeding in Preterm Infants 27-32 Weeks of Gestation (ETEFVsCEF)

Early Total Enteral Feeding Versus Convention Enteral Feeding in Preterm Infants 27-32 Weeks of Gestation

Early Total Enteral Feeding Versus Convention Enteral Feeding in Preterm Neonates Between 27 to 32 Weeks of Gestation: A Randomized Control Trial

The objective of the study is to compare the time of attainment of full enteral feeds in preterm neonates between 27-32 weeks of gestation started on early total enteral feeding (ETEF) with those started on conventional enteral feeding (CEF).

Enrolled participants will be randomly assigned to one of two study groups: 1) early total enteral feeding (ETEF) or 2) conventional enteral feeding (CEF). Regardless of study group assignment, mother's own breast milk (MOM) is the feed of choice and donor human milk is being offered if the MOM is not enough to complete the intervention as assigned Intervention group: Feeds will be initiated with a target volume of 80 ml/kg/day starting within the first two hours after birth. Volumes will increased by 20 ml/kg/day till day 4 (total 140 ml/kg/d) and then 150ml/kg/day on day 5. Control group: This group will receive enteral feeding volumes at a rate of 20 ml/kg/day starting within the first two hours after birth and rest of the daily requirement as Total parenteral nutrition. Volumes will be increased by 20 ml/kg/day till day 3 and thereafter by 30 ml/kg/d till 150ml/kg/day on day 6.

Mom's milk or donor milk at 20 ml/kg/day and rest of the requirement as Total parenteral nutrition after randomization within the first 2 hours.

This group will receive enteral feeding volumes at a rate of 80 ml/kg/day starting within the first two hours after birth. Volumes will increased by 20 ml/kg/day till day 4 (total 140 ml/kg/d) and then 150ml/kg/day on day 5.

This group will receive enteral feeding volumes at a rate of 20 ml/kg/day starting within the first two hours after birth and rest of the daily requirement as Total parenteral nutrition. Volumes will be increased by 20 ml/kg/day till day 3 and thereafter by 30 ml/kg/d till 150ml/kg/day on day 6.

Feed intolerance will be defined as any one or more of the following a) Vomiting 3 or more in any 24 hour period, b) Any episode of blood stained or bilious vomiting, c) Abdominal girth(AG) increase >2 cm (with pre-feed aspirate >25%), abdominal wall erythema or tenderness, gross or occult blood in stools

Sepsis will be defined as any one of the following in a symptomatic neonate a) Culture positive sepsis b) Sepsis screen positive, c) Strong clinical suspicion such as sclerema, shock or clinical deterioration on supportive therapy which warrants initiation of antibiotics (clinician decision)

The weight in grams at one month of age minus the birth weight divided by the average weight (average weight =birth weight +Weight at 1 month age divided by 2) further divided by 30

Weight of the infants at 36 weeks Postmenstrual age or at discharge (if earlier) below the 10th centile for age

Inclusion Criteria: Preterm neonate with gestational age of 27-32 weeks Exclusion Criteria: Antenatally diagnosed GI malformation Baby born with absence or reversal of end diastolic flow on antenatal umbilical artery Doppler. Presence of major congenital anomalies at birth Need of vasopressor support at the time of randomization Requiring Positive Pressure Ventilation > 60 sec with APGAR score < 4 at 1 minute

Walsh V, Brown JVE, Copperthwaite BR, Oddie SJ, McGuire W. Early full enteral feeding for preterm or low birth weight infants. Cochrane Database Syst Rev. 2020 Dec 27;12(12):CD013542. doi: 10.1002/14651858.CD013542.pub2.

Nangia S, Bishnoi A, Goel A, Mandal P, Tiwari S, Saili A. Early Total Enteral Feeding in Stable Very Low Birth Weight Infants: A Before and After Study. J Trop Pediatr. 2018 Feb 1;64(1):24-30. doi: 10.1093/tropej/fmx023.