NCT02915549

Brief Summary

To test the hypothesis that progressive feeding without minimal enteral feeding (MEF) compared to progressive feeding preceded by a 4-day course of MEF will result in an increased number of days alive on full enteral feeding in the first 28 days after birth in extremely preterm infants receiving human milk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

December 16, 2022

Status Verified

December 1, 2022

Enrollment Period

1.1 years

First QC Date

September 19, 2016

Last Update Submit

December 13, 2022

Conditions

Premature; Infant, Light-for-dates

Keywords

premature infantearly progressive feeding

Outcome Measures

Primary Outcomes (1)

  • Number of days alive and receiving full enteral feeding

    number of days alive on full enteral feeding in the first 28 days after birth

    birth to 28 days

Secondary Outcomes (13)

  • Number of participants with diagnosis of necrotizing enterocolitis

    birth to 120 days or discharge, whichever occurs first

  • Number of participants with diagnosis of intestinal perforation

    birth to 14 days

  • Death

    birth to 120 days

  • Number of days alive and receiving full enteral feeding according to time of exposure to human milk and formula feeding the first 28 days

    birth to 28 days

  • Time to establish full enteral feeding

    birth to 28 days

  • +8 more secondary outcomes

Study Arms (2)

Progressive Feeding without MEF

EXPERIMENTAL

This group will receive feeding volumes of 20-24ml/kg/d of day 1 of feeding followed by the study intervention of daily volume increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved.

Other: Progressive Feeding without MEF

Progressive Feeding with MEF

ACTIVE COMPARATOR

This group will receive minimal enteral feeds (MEF) with volumes of 20-24ml/kg/d for 4 days followed by daily increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved.

Other: Progressive Feeding with MEF

Interventions

Progressive Feeding without MEFOTHER

This group will receive feeding volumes of 20-24ml/kg/d of day 1 of feeding followed by the study intervention of daily volume increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved.

Progressive Feeding without MEF
Progressive Feeding with MEFOTHER

This group will receive minimal enteral feeds (MEF) with volumes of 20-24ml/kg/d for 4 days followed by daily increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved.

Progressive Feeding with MEF

Eligibility Criteria

Age24 Hours - 48 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • admission to the NICU within 48 hours with gestational age between 22.0 and 28.6 weeks

You may not qualify if:

  • small for gestational age (\<10th percentile birthweight), major congenital or chromosomal anomalies, and infants with terminal illness in which decision 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, 35249, United States

Location

Related Publications (3)

  • Salas AA, Li P, Parks K, Lal CV, Martin CR, Carlo WA. Early progressive feeding in extremely preterm infants: a randomized trial. Am J Clin Nutr. 2018 Mar 1;107(3):365-370. doi: 10.1093/ajcn/nqy012.

    PMID: 29529231RESULT

  • Salas AA, Willis KA, Carlo WA, Yi N, Zhang L, Van Der Pol WJ, Younge NE, Lefkowitz EJ, Lal CV. The gut microbiome of extremely preterm infants randomized to the early progression of enteral feeding. Pediatr Res. 2022 Sep;92(3):799-804. doi: 10.1038/s41390-021-01831-w. Epub 2021 Nov 13.

    PMID: 34775476RESULT

  • Durham L, Gunawan E, Nguyen K, Reeves A, Shukla V, Salas AA. Total Fluid Administration and Weight Loss during the First 2 Weeks in Infants Randomized to Early Enteral Feeding after Extremely Preterm Birth. Neonatology. 2023;120(2):257-262. doi: 10.1159/000527430. Epub 2022 Nov 28.

    PMID: 36442467RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ariel A. Salas, MD, MSPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 19, 2016

First Posted

September 27, 2016

Study Start

September 1, 2016

Primary Completion

October 1, 2017

Study Completion

November 1, 2022

Last Updated

December 16, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)