Exclusive Enteral Nutrition in Preterm Neonates (ENACT)

Exclusive Enteral Nutrition in Preterm Neonates- A Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Enteral Feeding Intolerance; Premature; Infant, Light-for-dates
• Intervention / Treatment: Procedure: Exclusive Enteral Nutrition; Procedure: Progressive Enteral 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).

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 2 days (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Exclusive Enteral Nutrition; Mom's milk or donor milk at 60-80 ml/kg/day after randomization within the first 24 hours.
Active Comparator: 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.	Procedure: Progressive Enteral Nutrition; Mom's milk or donor milk at 20-30 ml/kg/day after randomization within the first 24 hours.

What is the study measuring?

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
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
Time to establish full enteral feeding	Time interval between birth and full enteral feeding at 150ml/kg/day	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal microbiome profile	Determined by molecular analyses of bacterial fragments in fecal samples	At postnatal day 14
Fat-free mass z score	Determined by air-displacement plethysmography	At postnatal day 14

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Study Chair: Vivek Shukla, MD, University of Alabama at Birmingham; Study Director: Ariel Salas, MD, MSPH, University of Alabama at Birmingham; Principal Investigator: Jacqueline Razzaghy, MD, University of Alabama at Birmingham

Publications and helpful links

General Publications

• Razzaghy J, Shukla VV, Gunawan E, Reeves A, Nguyen K, Salas AA. Early and exclusive enteral nutrition in infants born very preterm. Arch Dis Child Fetal Neonatal Ed. 2023 Dec 22:fetalneonatal-2023-325969. doi: 10.1136/archdischild-2023-325969. Online ahead of print.

Helpful Links

• Commentary

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2021
• Primary Completion (Actual): September 12, 2022
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: April 3, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (Actual): April 8, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 300004922

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No