Early Progressive Feeding in Human-Milk Fed Extremely Preterm Infants: A Randomized Trial

January 6, 2022 updated by: Ariel A. Salas, University of Alabama at Birmingham
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Qualifying participants will be randomly assigned to one of two study groups: 1) Early progressive feeding without MEF or 2) Progressive feedings preceded by 4 days of MEF. Regardless of study group assignment, donor human milk will be offered if not enough of the mother's expressed breastmilk during the intervention phase of the trial.

Intervention group: Progressive feeding of 20-24 ml/kg/d on day 1 of feeding, followed by daily increments of 24-25 ml/kg/d as tolerated until full enteral feeding achieved.

Control group: MEF with feeding volumes of 20-24 ml/kg/d for 4 days followed by progressive feeding (daily increments of 24-25 ml/kg/d) as tolerated until full enteral feeding achieved.

Both groups will receive fast progressive feeding (>/= 24 ml/kg/day)

If parent agrees, stool "dirty" diapers will be collected 5 times (at birth, 1, 2, 3 and 4 weeks of life).

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Progressive Feeding without MEF
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
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.
Active Comparator: Progressive Feeding with MEF
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days alive and receiving full enteral feeding
Time Frame: birth to 28 days
number of days alive on full enteral feeding in the first 28 days after birth
birth to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with diagnosis of necrotizing enterocolitis
Time Frame: birth to 120 days or discharge, whichever occurs first
diagnosis of necrotizing enterocolitis stage 2 or 3
birth to 120 days or discharge, whichever occurs first
Number of participants with diagnosis of intestinal perforation
Time Frame: birth to 14 days
birth to 14 days
Death
Time Frame: birth to 120 days
death prior to 121 days of birth
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
Time Frame: birth to 28 days
birth to 28 days
Time to establish full enteral feeding
Time Frame: birth to 28 days
time interval between birth and full enteral feeding at 120cc/kg/day
birth to 28 days
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
birth to 28 days
Number of episodes of feeding intolerance resulting in an interruption or cessation of progressive enteral feeding for a period < 12 hours
Time Frame: birth to 28 days
birth to 28 days
Number of days receiving parenteral nutrition
Time Frame: birth to 28 days
birth to 28 days
Number of days requiring central line access
Time Frame: birth to 28 days
birth to 28 days
Number of episodes of culture proven sepsis
Time Frame: birth to 120 days or discharge, whichever occurs first
birth to 120 days or discharge, whichever occurs first
Growth/length at time of discharge
Time Frame: birth to 120 days or discharge, whichever occurs first
birth to 120 days or discharge, whichever occurs first
Duration of hospital stay in days
Time Frame: birth to 120 days or discharge, whichever occurs first
birth to 120 days or discharge, whichever occurs first
Changes in intestinal microbiome
Time Frame: birth to 28 days
Determined by molecular analyses of bacteria in fecal samples
birth to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

The Gerber Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

September 19, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (Estimate)

September 27, 2016

Study Record Updates

Last Update Posted (Actual)

January 10, 2022

Last Update Submitted That Met QC Criteria

January 6, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F160609004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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