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Dietary Supplement

Early Human Milk Fortification for Premature Infants (ENACT+ Trial)

N/A
Waitlist Available
Led By Ariel A. Salas, MD, MSPH
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postnatal day 14 to 21
Awards & highlights

ENACT+ Trial Summary

This trial will test if giving very preterm infants protein supplements earlier helps them grow better and have healthier gut microbiomes.

Who is the study for?
This trial is for very preterm infants with a birth weight under 1800 grams and aged less than 96 hours, born between 29 to 33 weeks of gestation. It's not suitable for babies small for their gestational age, those with terminal illnesses where support is limited, or major congenital/chromosomal anomalies.Check my eligibility
What is being tested?
The study tests if giving very preterm infants protein supplements early (between day 4-7) versus later (day 10-14) affects their body composition and gut bacteria diversity. The trial randomly assigns infants to one of the two groups.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include feeding intolerance or reactions related to the timing and introduction of human milk fortification in these vulnerable infants.

ENACT+ Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postnatal day 14 to 21
This trial's timeline: 3 weeks for screening, Varies for treatment, and postnatal day 14 to 21 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fat-free mass(FFM)-for-age Z-score
Secondary outcome measures
Death
Duration of hospital stay in days
Fecal microbiome composition
+7 more

ENACT+ Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early human milk fortification (HMF) groupExperimental Treatment1 Intervention
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.
Group II: Delayed human milk fortification (HMF) groupActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,580 Previous Clinical Trials
2,275,915 Total Patients Enrolled
Mead Johnson NutritionIndustry Sponsor
79 Previous Clinical Trials
16,288 Total Patients Enrolled
Ariel A. Salas, MD, MSPHPrincipal InvestigatorUniversity of Alabama at Birmingham
4 Previous Clinical Trials
166 Total Patients Enrolled

Media Library

Delayed HMF (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT05525585 — N/A
Premature Infants Research Study Groups: Early human milk fortification (HMF) group, Delayed human milk fortification (HMF) group
Premature Infants Clinical Trial 2023: Delayed HMF Highlights & Side Effects. Trial Name: NCT05525585 — N/A
Delayed HMF (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05525585 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment of participants open for this scientific experiment?

"According to clinicaltrials.gov, this research endeavour is currently searching for participants. Its initial posting was on November 17th 2022, and its most recent alteration was made a fortnight later."

Answered by AI

Am I able to register for the clinical trial at this time?

"This research requires 80 participants with lactose intolerance, aged 1 day to 4 days old. Additionally, the newborns must have a gestational age of 29-33 weeks and weigh less than 1800 grams at birth. Finally, their postnatal age needs to be under 96 hours."

Answered by AI

How many people have enrolled in this clinical investigation?

"Affirmative. According to the most recent records available on clinicaltrials.gov, this research endeavour was originally published in mid-November 2022 and has since had an update applied. Currently 80 individuals are required for enrolment at a single medical site."

Answered by AI

Is this study open to adults aged 18 and older?

"This clinical trial seeks applicants aged 1 Day to 4 Days. 202 trials are available for minors, while 80 studies target those 65 years and older."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants
Ariel A. Salas 2022. "Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05525585.
~33 spots leftby Apr 2025
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