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Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants (ENACT+)

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Active, not recruiting

Conditions

Prematurity
Light-For-Dates
Enteral Feeding Intolerance

Treatments

Dietary Supplement: Early HMF
Dietary Supplement: Delayed HMF

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05525585
300009921
000538159 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

1 to 4 days old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Early human milk fortification (HMF) group
Experimental group
Description:
A human milk fortifier will be added to the feeds between days 4 to 7, after a total feeding volume greater than 120 ml/kg/day is achieved.
Treatment:
Dietary Supplement: Early HMF
Delayed human milk fortification (HMF) group
Active Comparator group
Description:
A human milk fortifier will be added to the feeds between days 10 to 14, after a total feeding volume greater than 120 ml/kg/day is achieved.
Treatment:
Dietary Supplement: Delayed HMF

Trial contacts and locations

1

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Central trial contact

Ariel A. Salas, MD, MSPH

Data sourced from clinicaltrials.gov

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