Exclusive Enteral Nutrition in Preterm Neonates

Not Applicable

Active, not recruiting

• Conditions: Enteral Feeding Intolerance; Premature; Infant, Light-for-dates
• Interventions: Procedure: Exclusive Enteral Nutrition; Procedure: Progressive Enteral Nutrition

• Registration Number: NCT04337710
• Lead Sponsor: University of Alabama at Birmingham

Brief 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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-06
• Study First Posted: 2020-04-08
• Study Start: 2021-05-27
• Primary Completion: 2022-09-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Gestational age between 28 and 32 weeks of gestation

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exclusive Enteral Nutrition	Exclusive Enteral Nutrition	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.
Progressive Enteral Nutrition	Progressive Enteral Nutrition	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.

Primary Outcome Measures

Name	Time	Method
Number of days of full enteral feeding (150ml/kg/day) in the first 28 days after birth	Birth to 28 days	Days of full feeds in the first 28 days after birth

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States