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Dietary Supplement

Human Milk Fortification for Premature Infants

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
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

Study 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
My baby was born at or before 27 weeks and admitted to the NICU within their first week.


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

Frequently Asked Questions

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

To what extent is the patient base involved in this experiment?

"Affirmative, the data hosted on clinicaltrials.gov suggest that this research project is presently accruing individuals for participation. This endeavour, which was first uploaded to the website on February 15th 2020 and last updated August 3rd 2021, requires 200 participants from one distinct centre."

Answered by AI

Am I qualified to participate in this experiment?

"This medical study is recruiting up to 200 infants with enterocolitis between 0 days and 6 days of age."

Answered by AI

Are enrollment opportunities still available for this clinical trial?

"Affirmative. The clinicaltrial.gov listing reveals that this research, which was originally posted on February 15th 2020, is presently recruiting participants. 200 individuals need to be enlisted from one centre in total."

Answered by AI

Is this clinical trial admitting geriatric individuals as participants?

"According to the criteria for inclusion in this medical trial, neonates aged 0-6 days qualify."

Answered by AI
~39 spots leftby Apr 2025