Clinical trial NCT06076460: Early Total Enteral Feeding Versus Convention Enteral Feeding in Preterm Infants 27-32 Weeks of Gestation
Official title: Early Total Enteral Feeding Versus Convention Enteral Feeding in Preterm Neonates Between 27 to 32 Weeks of Gestation: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Very Preterm Maturity of Infant
Enteral Feeding Intolerance
Lead sponsor: Lady Hardinge Medical College
Sponsor class: OTHER_GOV
First posted: 2023-10-10
Enrollment: 183
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Preterm neonate with gestational age of 27-32 weeks

Exclusion Criteria:

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 at birth
4. Need of vasopressor support at the time of randomization
5. Requiring Positive Pressure Ventilation \> 60 sec with APGAR score \< 4 at 1 minute

Primary outcomes:
measure: Time of attainment of full enteral feeds (150ml/kg/day) during the first 28 days after birth
timeFrame: Birth to 28 days
Secondary outcomes:
measure: Number of episodes of feeding intolerance
timeFrame: From Randomization till 28 days after birth
measure: Incidence of Necrotising Enterocolitis
timeFrame: From Randomization till 28 days after birth
measure: Incidence of Sepsis
timeFrame: From randomization till 28 days after birth
measure: Total duration of intravenous fluid usage
timeFrame: From randomization till 28 days after birth
measure: Time of regaining birth weight
timeFrame: From randomization till 28 days after birth
measure: Total duration of hospital stay
timeFrame: From randomization till 2 months after birth
measure: Weight gain per kg per day at 1 month of age
timeFrame: Birth to 30 days
measure: Extrauterine growth retardation (EUGR)
timeFrame: Till 36 weeks Postmenstrual age
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Lady Hardinge Medical College
state: Delhi
Study officials:
affiliation: Lady Hardinge Medical College
name: Sushma Nangia, DM (NEO)
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.