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Exclusive Enteral Nutrition in Preterm Neonates (ENACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04337710
Recruitment Status : Active, not recruiting
First Posted : April 8, 2020
Last Update Posted : May 19, 2023
Sponsor:
Information provided by (Responsible Party):
Ariel A. Salas, University of Alabama at Birmingham

Study Description
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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.

Condition or disease Intervention/treatment Phase
Premature; Infant, Light-for-dates Enteral Feeding Intolerance Procedure: Exclusive Enteral Nutrition Procedure: Progressive Enteral Nutrition Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Exclusive Enteral Nutrition in Preterm Neonates- A Randomized Controlled Trial
Actual Study Start Date : May 27, 2021
Actual Primary Completion Date : September 12, 2022
Estimated Study Completion Date : December 2023
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of days of full enteral feeding (150ml/kg/day) in the first 28 days after birth [ Time Frame: Birth to 28 days ]
    Days of full feeds in the first 28 days after birth


Secondary Outcome Measures :
  1. Time to establish full enteral feeding [ Time Frame: Birth to 28 days ]
    Time interval between birth and full enteral feeding at 150ml/kg/day

  2. Number of episodes of feeding intolerance [ Time Frame: Birth to 28 days ]
    Interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination

  3. Number of days receiving parenteral nutrition and IV fluids [ Time Frame: Birth to 28 days ]
  4. Number of days receiving central line access [ Time Frame: Birth to 28 days ]
  5. Number of episodes of culture proven sepsis [ Time Frame: Birth to 60 days or discharge, whichever occurs first ]
    Positive blood cultures

  6. Number of participants with diagnosis of necrotizing enterocolitis [ Time Frame: Birth to 60 days or discharge, whichever occurs first ]
    Diagnosis of necrotizing enterocolitis stage 2 or 3

  7. Number of participants with diagnosis of intestinal perforation [ Time Frame: Birth to 14 days ]
    Pneumoperitoneum on abdominal radiograph

  8. Death [ Time Frame: Birth to 60 days ]
  9. Weight [ Time Frame: Birth to 60 days ]
    Weekly measurements of weight in g

  10. Length [ Time Frame: Birth to 60 days ]
    Weekly measurements of length in cm

  11. Head circumference [ Time Frame: Birth to 60 days ]
    Weekly measurements of head circumference in cm

  12. Duration of hospital stay in days [ Time Frame: Birth to 60 days ]

Other Outcome Measures:
  1. Intestinal microbiome profile [ Time Frame: At postnatal day 14 ]
    Determined by molecular analyses of bacterial fragments in fecal samples

  2. Fat-free mass z score [ Time Frame: At postnatal day 14 ]
    Determined by air-displacement plethysmography


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Hour to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04337710


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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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
More Information
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Responsible Party: Ariel A. Salas, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04337710    
Other Study ID Numbers: 300004922
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: May 19, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No