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Completed

NCT Number: NCT02915549

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

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.

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Key information

Conditions

Premature; Infant, Light-for-dates Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

24 hour–48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progressive Feeding without MEF

Other

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 with MEF

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Number of participants with diagnosis of intestinal perforation

    Time frame: birth to 14 days

  3. Death

    Time frame: birth to 120 days

    death prior to 121 days of birth

  4. 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

  5. Time to establish full enteral feeding

    Time frame: birth to 28 days

    time interval between birth and full enteral feeding at 120cc/kg/day

  6. 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

  7. 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

  8. Number of days receiving parenteral nutrition

    Time frame: birth to 28 days

  9. Number of days requiring central line access

    Time frame: birth to 28 days

  10. Number of episodes of culture proven sepsis

    Time frame: birth to 120 days or discharge, whichever occurs first

  11. Growth/length at time of discharge

    Time frame: birth to 120 days or discharge, whichever occurs first

  12. Duration of hospital stay in days

    Time frame: birth to 120 days or discharge, whichever occurs first

  13. Changes in intestinal microbiome

    Time frame: birth to 28 days

    Determined by molecular analyses of bacteria in fecal samples

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • The Gerber Foundation

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2022
First posted
Sep 27, 2016
Registry last updated
Dec 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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