NCT04337710

Exclusive Enteral Nutrition in Preterm Neonates

Exclusive Enteral Nutrition in Preterm Neonates- A Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 1 Hour – 48 Hours
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Exclusive Enteral Nutrition	Mom's milk or donor milk at 60-80 ml/kg/day after randomization within the first 24 hours.
PROCEDURE	Progressive Enteral Nutrition	Mom's milk or donor milk at 20-30 ml/kg/day after randomization within the first 24 hours.

Timeline

• Start date: 2021-05-27
• Primary completion: 2022-09-12
• Completion: 2026-05-01
• First posted: 2020-04-08
• Last updated: 2025-08-17

Locations

1 site across 1 country: United States