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

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)

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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