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Dietary Supplement

Human Milk Fortification for Premature Infants

N/A
Recruiting
Led By Bouraa Bou Aram, MD
Research Sponsored by Crouse Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All extremely preterm infants with gestational age less or equal to 27 weeks who are admitted to the NICU prior to day of life seven and the first enteral feeding
Be younger than 18 years old
Must not have
Infants with severe congenital anomalies such as chromosomal trisomy, congenital heart disease, and abdominal wall defect
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessment will happen at two years adjusted age ( approximately 4 years from the time recruitment starts)
Awards & highlights

Summary

This trial is studying whether adding a fortifier to preterm human milk will improve outcomes for extremely premature babies.

Who is the study for?
This trial is for extremely preterm infants born at or before 27 weeks of gestation. They must be admitted to the NICU before they are seven days old and prior to their first feeding. Infants with serious birth defects like chromosomal trisomy, heart issues, or abdominal wall defects cannot participate.Check my eligibility
What is being tested?
The study compares two approaches: routinely adding a Human Milk Donor Fortifier to the diets of these preterm infants versus doing so selectively based on specific needs. The goal is to see how this affects their growth and health outcomes.See study design
What are the potential side effects?
Potential side effects may include digestive system reactions due to fortification such as bloating, gas, or changes in stool patterns. However, since it involves human milk fortification, severe side effects are not commonly expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby was born at or before 27 weeks and admitted to the NICU within their first week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My infant has a severe birth defect like Down syndrome, heart issues, or abdominal wall problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessment will happen at two years adjusted age ( approximately 4 years from the time recruitment starts)
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessment will happen at two years adjusted age ( approximately 4 years from the time recruitment starts) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
In-Hospital growth in extremely preterm infants
Necrotizing Enterocolitis (NEC)
Neurodevelopmental outcome
Secondary outcome measures
The difference in growth (if any) at two years

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early Routine FortificationExperimental Treatment1 Intervention
Human Milk Donor Fortifier added to preterm human milk (maternal or donor) when feeds of 150 ml/kg/day are reached (120Kcal/kg/day)
Group II: Selective FortificationActive Control1 Intervention
Human Milk Donor Fortifier added to preterm human milk (maternal or donor) only for weight gain less than 15g/kg/day after full feeds of 180 ml/kg/day are achieved (120 Kcal/kg/day). If milk of any infant in the selective fortification group gets fortified the volume will be decreased to 150 ml/kg/day to keep the total caloric intake equal.

Find a Location

Who is running the clinical trial?

Crouse HospitalLead Sponsor
2 Previous Clinical Trials
216 Total Patients Enrolled
Bouraa Bou Aram, MDPrincipal Investigator - Crouse Hospital
Crouse Hospital
Swati Murthy, MDPrincipal InvestigatorCrouse Hospital

Media Library

Human Milk Donor Fortifier (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04284280 — N/A
Poor Growth in Preterm Infants Research Study Groups: Early Routine Fortification, Selective Fortification
Poor Growth in Preterm Infants Clinical Trial 2023: Human Milk Donor Fortifier Highlights & Side Effects. Trial Name: NCT04284280 — N/A
Human Milk Donor Fortifier (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04284280 — N/A
~37 spots leftby Jul 2025
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