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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Very Preterm Maturity of Infant, Enteral Feeding Intolerance

Intervention / Treatment
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* Other: Early Total Enteral Feeding
* Other: Conventional Enteral Feeding


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 1 Hour

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Total Enteral Feeding<br>Mom's milk or donor milk at 80 ml/kg/day after randomization within the first 2 hours | Other: Early Total Enteral Feeding<br>* 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.<br>|
| Active Comparator: Conventional Enteral Feeding<br>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. | Other: Conventional Enteral Feeding<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of attainment of full enteral feeds (150ml/kg/day) during the first 28 days after birth | Days to attain full feeds during the first 28 days after birth | Birth to 28 days | 

Secondary Outcome Measures

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