Exclusive Enteral Nutrition in Preterm Neonates (ENACT)

The University of Alabama at Birmingham

Status: Active, not recruiting

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

Treatments: Procedure: Exclusive Enteral Nutrition; Procedure: Progressive Enteral Nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT04337710

300004922

Details and patient eligibility

About

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.

Full 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).

Enrollment: 102 patients

Sex: All

Ages: 1 to 48 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Exclusive Enteral Nutrition

Experimental group

Description:

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.

Treatment:

Procedure: Exclusive Enteral Nutrition

Progressive Enteral Nutrition

Active Comparator group

Description:

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.

Treatment:

Procedure: Progressive Enteral Nutrition