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

Not Applicable

Completed

• Conditions: Enteral Feeding Intolerance; Very Preterm Maturity of Infant
• Interventions: Other: Conventional Enteral Feeding; Other: Early Total Enteral Feeding

• Registration Number: NCT06076460
• Lead Sponsor: Lady Hardinge Medical College

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.

Study Timeline

• Study Start: 2022-03-11
• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-10-06
• Study First Posted: 2023-10-10
• Primary Completion: 2024-01-10
• Study Completion: 2024-01-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Enteral Feeding	Conventional Enteral Feeding	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.
Early Total Enteral Feeding	Early Total Enteral Feeding	Mom's milk or donor milk at 80 ml/kg/day after randomization within the first 2 hours

Primary Outcome Measures

Name	Time	Method
Time of attainment of full enteral feeds (150ml/kg/day) during the first 28 days after birth	Birth to 28 days	Days to attain full feeds during the first 28 days after birth

Secondary Outcome Measures

Name	Time	Method
Number of episodes of feeding intolerance	From Randomization till 28 days after birth	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
Incidence of Sepsis	From randomization till 28 days after birth	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)
Incidence of Necrotising Enterocolitis	From Randomization till 28 days after birth	Diagnosis of necrotizing enterocolitis any stage
Time of regaining birth weight	From randomization till 28 days after birth	Duration in completed days required to regain birth weight
Weight gain per kg per day at 1 month of age	Birth to 30 days	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
Total duration of intravenous fluid usage	From randomization till 28 days after birth	Duration in completed days for which infant required parenteral fluid support
Total duration of hospital stay	From randomization till 2 months after birth	Duration in completed days required for treatment till discharge home or till death
Extrauterine growth retardation (EUGR)	Till 36 weeks Postmenstrual age	Weight of the infants at 36 weeks Postmenstrual age or at discharge (if earlier) below the 10th centile for age

Trial Locations

Locations (1)

Lady Hardinge Medical College; 🇮🇳 New Delhi, Delhi, India