NCT04337710

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 27, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2022

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

August 17, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

April 3, 2020

Last Update Submit

August 14, 2025

Conditions

Premature; Infant, Light-for-datesEnteral Feeding Intolerance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Time to establish full enteral feeding

    Birth to 28 days

  • Number of episodes of feeding intolerance

    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

    Birth to 60 days or discharge, whichever occurs first

  • +7 more secondary outcomes

Other Outcomes (2)

  • Intestinal microbiome profile

    At postnatal day 14

  • Fat-free mass z score

    At postnatal day 14

Study Arms (2)

Exclusive Enteral Nutrition

EXPERIMENTAL

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

Progressive Enteral Nutrition

ACTIVE COMPARATOR

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

Interventions

Exclusive Enteral NutritionPROCEDURE

Mom's milk or donor milk at 60-80 ml/kg/day after randomization within the first 24 hours.

Exclusive Enteral Nutrition
Progressive Enteral NutritionPROCEDURE

Mom's milk or donor milk at 20-30 ml/kg/day after randomization within the first 24 hours.

Progressive Enteral Nutrition

Eligibility Criteria

Age1 Hour - 48 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age between 28 and 32 weeks of gestation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (2)

  • 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. 2024 Jun 19;109(4):378-383. doi: 10.1136/archdischild-2023-325969.

    PMID: 38135494RESULT

  • Salas AA, Stewart CJ, Young GR. Early gut microbiome composition of very preterm infants randomised to receive human milk volumes of 60 ml/kg/day or more within the first 36 hours after birth. Pediatr Res. 2025 Oct 2. doi: 10.1038/s41390-025-04456-5. Online ahead of print.

    PMID: 41034647DERIVED

Related Links

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Vivek Shukla, MD

    University of Alabama at Birmingham

    STUDY CHAIR

  • Ariel Salas, MD, MSPH

    University of Alabama at Birmingham

    STUDY DIRECTOR

  • Jacqueline Razzaghy, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 3, 2020

First Posted

April 8, 2020

Study Start

May 27, 2021

Primary Completion

September 12, 2022

Study Completion

May 1, 2026

Last Updated

August 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)