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

Prematurity Clinical Trial

— ENACT+  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05525585
• Other study ID #: 300009921
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 17, 2022
• Est. completion date: October 2024

Study information

• Verified date: June 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: October 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 4 Days

Eligibility

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

Related Conditions & MeSH terms

• Enteral Feeding Intolerance
• Premature Birth
• Prematurity

Intervention

Dietary Supplement:
• Early HMF
Mom's milk or donor milk will be fortified between postnatal day 4 and 7
• Delayed HMF
Mom's milk or donor milk will be fortified between postnatal day 10 and 14

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Mead Johnson Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat-free mass(FFM)-for-age Z-score	Estimated by air displacement plethysmography	Postnatal day 14 to 21
Secondary	Fecal microbiome composition	Determined by 16S RNA sequencing of bacteria in stool samples	Birth to 36 weeks postmenstrual age
Secondary	Growth - Weight	Measured weekly in grams and z scores as part of routine care	Birth to 36 weeks postmenstrual age or hospital discharge
Secondary	Growth - Length	Measured weekly in cm and z scores as part of routine care	Birth to 36 weeks postmenstrual age or hospital discharge
Secondary	Growth - Head circumference	Measured weekly in cm and z scores as part of routine care	Birth to 36 weeks postmenstrual age or hospital discharge
Secondary	Growth rate	Weight gain in g/kg/day	Birth to 36 weeks postmenstrual age or hospital discharge
Secondary	Number of participants with postnatal growth faltering	Diagnosis of growth faltering (decline in weight-for-age z score from birth to 36 weeks postmenstrual age greater than 1.2	Birth to 36 weeks postmenstrual age or hospital discharge
Secondary	Number of participants with diagnosis of necrotizing enterocolitis	Diagnosis of necrotizing enterocolitis stage 2 or 3	Birth to 60 days or discharge
Secondary	Number of participants with diagnosis of intestinal perforation	Diagnosis of intestinal perforation	Birth to 10 days
Secondary	Death	Death prior to postnatal day 60	Birth to 60 days
Secondary	Duration of hospital stay in days	From day of admission to day of hospital discharge to home	Birth to 60 days or discharge, whichever occurs first