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NCT Number: NCT05525585

Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants

In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early protein supplementation through early fortification results in higher FFM-for-age z scores and more diversity in the gut microbiome.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prematurity Enteral Feeding Intolerance Female Urogenital Diseases and Pregnancy Complications Light-For-Dates Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–4 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Gestational age 29 to 33 weeks of gestation
  • Birth weight < 1800 g
  • Postnatal age < 96 hours

Exclusion criteria

  • Small for gestational age (<5th percentile)
  • Major congenital/chromosomal anomalies
  • Terminal illness needing withhold or limit support

Treatment and study plan

Early HMF

Dietary Supplement

Mom's milk or donor milk will be fortified between postnatal day 4 and 7

Delayed HMF

Dietary Supplement

Mom's milk or donor milk will be fortified between postnatal day 10 and 14

Primary outcomes

  1. Fat-free mass(FFM)-for-age Z-score

    Time frame: Postnatal day 14 to 21

    Estimated by air displacement plethysmography

Secondary outcomes

  1. Fecal microbiome composition

    Time frame: Birth to 36 weeks postmenstrual age

    Determined by 16S RNA sequencing of bacteria in stool samples

  2. Growth - Weight

    Time frame: Birth to 36 weeks postmenstrual age or hospital discharge

    Measured weekly in grams and z scores as part of routine care

  3. Growth - Length

    Time frame: Birth to 36 weeks postmenstrual age or hospital discharge

    Measured weekly in cm and z scores as part of routine care

  4. Growth - Head circumference

    Time frame: Birth to 36 weeks postmenstrual age or hospital discharge

    Measured weekly in cm and z scores as part of routine care

  5. Growth rate

    Time frame: Birth to 36 weeks postmenstrual age or hospital discharge

    Weight gain in g/kg/day

  6. Number of participants with postnatal growth faltering

    Time frame: Birth to 36 weeks postmenstrual age or hospital discharge

    Diagnosis of growth faltering (decline in weight-for-age z score from birth to 36 weeks postmenstrual age greater than 1.2

  7. Number of participants with diagnosis of necrotizing enterocolitis

    Time frame: Birth to 60 days or discharge

    Diagnosis of necrotizing enterocolitis stage 2 or 3

  8. Number of participants with diagnosis of intestinal perforation

    Time frame: Birth to 10 days

    Diagnosis of intestinal perforation

  9. Death

    Time frame: Birth to 60 days

    Death prior to postnatal day 60

  10. Duration of hospital stay in days

    Time frame: Birth to 60 days or discharge, whichever occurs first

    From day of admission to day of hospital discharge to home

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Mead Johnson Nutrition

Registry information

Official study title

Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants: a Randomized Clinical Trial

Acronym: ENACT+

Important dates

Study start
2022
Primary completion
2023
Study completion
2027
First posted
Sep 1, 2022
Registry last updated
Jun 15, 2026

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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