Exclusive Enteral Nutrition in Preterm Neonates

Study Overview
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Brief Summary
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To test the hypothesis that early exclusive enteral nutrition with the minimal use of parenteral nutrition will improve preterm infants' nutritional outcomes when compared to delayed progression of enteral nutrition and prolonged use of parenteral nutrition.

Detailed Description
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Qualifying participants will be randomly assigned to one of two study groups: 1) Exclusive Enteral Feeds or 2) Progressive Enteral Feeds with supplemental parenteral nutrition. Regardless of study group assignment, donor human milk will be offered if the mother's expressed breast milk is not enough to complete the intervention as assigned. Intervention group: Feeds will be initiated with a target volume of 60-80 ml/kg/day and then advanced by 20-30 ml/kg/day until the total volume of 150ml/kg/day is achieved. Control group: Enteral feeds will be initiated with a target volume of 20-30 ml/kg/day and then advanced by 20-30 ml/kg/day until the total volume of 150 ml/kg/day is achieved. If parent agrees, stool dirty diapers will be collected 2 times during this study. One time around the time of birth and one time at 28 days or discharge (whichever occurs first).

Official Title
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Exclusive Enteral Nutrition in Preterm Neonates- A Randomized Controlled Trial

Conditions
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Premature; Infant, Light-for-dates, Enteral Feeding Intolerance

Intervention / Treatment
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* Procedure: Exclusive Enteral Nutrition
* Procedure: Progressive Enteral Nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age between 28 and 32 weeks of gestation Exclusion Criteria: Intrauterine growth restriction (birth weight < 10th percentile) Major congenital or chromosomal anomalies Terminal illness in which decisions to withhold or limit support have been made

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 48 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exclusive Enteral Nutrition<br>This group will receive enteral feeding volumes at a rate of 60-80 ml/kg/day starting within the first 24 hours after birth. Volumes will increase by 20-30 ml/kg/day until intake is 150ml/kg/day. | Procedure: Exclusive Enteral Nutrition<br>* Mom's milk or donor milk at 60-80 ml/kg/day after randomization within the first 24 hours.<br>|
| Active Comparator: Progressive Enteral Nutrition<br>This group will receive enteral feeding volumes at a rate of 20-30 ml/kg/day starting within the first 24 hours after birth. Volumes will increase by 20-30 ml/kg/day until intake is 150ml/kg/day. | Procedure: Progressive Enteral Nutrition<br>* Mom's milk or donor milk at 20-30 ml/kg/day after randomization within the first 24 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to establish full enteral feeding | Time interval between birth and full enteral feeding at 150ml/kg/day | Birth to 28 days | 
| Number of episodes of feeding intolerance | Interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination | Birth to 28 days | 
| Number of days receiving parenteral nutrition and IV fluids |  | Birth to 28 days | 
| Number of days receiving central line access |  | Birth to 28 days | 
| Number of episodes of culture proven sepsis | Positive blood cultures | Birth to 60 days or discharge, whichever occurs first | 
| Number of participants with diagnosis of necrotizing enterocolitis | Diagnosis of necrotizing enterocolitis stage 2 or 3 | Birth to 60 days or discharge, whichever occurs first | 
| Number of participants with diagnosis of intestinal perforation | Pneumoperitoneum on abdominal radiograph | Birth to 14 days | 
| Death |  | Birth to 60 days | 
| Weight | Weekly measurements of weight in g | Birth to 60 days | 
| Length | Weekly measurements of length in cm | Birth to 60 days | 
| Head circumference | Weekly measurements of head circumference in cm | Birth to 60 days | 
| Duration of hospital stay in days |  | Birth to 60 days |