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Individualized Human Milk Fortification for Very Low Birth Weight Infants

N/A
Recruiting
Led By Deborah O'Connor, PhD RD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≤1250 g birth weight
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18-24 months ca
Awards & highlights

Study Summary

This trial will study whether two different methods of fortifying human milk for very low birth weight infants results in improved growth or neurodevelopment.

Who is the study for?
This trial is for infants born weighing ≤ 1250 g. They must have parental consent and can use donor milk if needed. Infants who might transfer to a non-participating NICU, received fortifiers or formula before the study, are over 21 days old at start, in another nutrition study, or have growth-affecting anomalies cannot join.Check my eligibility
What is being tested?
The trial tests how very low birth weight infants grow when their human milk is fortified using three different methods: standard fortification, target fortification based on desired nutrient levels, and BUN adjustable fortification that adapts to the infant's current nutritional status.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include digestive issues due to intolerance of added nutrients in fortified feeds. Close monitoring will likely minimize risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby was born weighing 1250 grams or less.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18-24 months ca
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18-24 months ca for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cognitive Composite Score
Secondary outcome measures
Body composition at the end of the intervention
Head circumference gain during the intervention
Language Composite Score
+4 more
Other outcome measures
Body composition at follow-up
Brain--connectivity
Brain--event related potentials
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Target fortificationExperimental Treatment1 Intervention
Group II: BUN adjustable fortificationExperimental Treatment1 Intervention
Group III: Standard fortificationActive Control1 Intervention

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
683 Previous Clinical Trials
6,944,379 Total Patients Enrolled
Deborah O'Connor, PhD RDPrincipal InvestigatorThe Hospital for Sick Children
Sharon Unger, MDPrincipal InvestigatorSinai Health System
1 Previous Clinical Trials
112 Total Patients Enrolled

Media Library

BUN adjustable fortification Clinical Trial Eligibility Overview. Trial Name: NCT05308134 — N/A
Very Low Birthweight Research Study Groups: Standard fortification, Target fortification, BUN adjustable fortification
Very Low Birthweight Clinical Trial 2023: BUN adjustable fortification Highlights & Side Effects. Trial Name: NCT05308134 — N/A
BUN adjustable fortification 2023 Treatment Timeline for Medical Study. Trial Name: NCT05308134 — N/A

Frequently Asked Questions

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

Are individuals able to apply for this research initiative presently?

"Clinicaltrials.gov attests to this study's ongoing recruitment efforts, which began November 11th 2021 and have been amended as recently as April 1st 2022."

Answered by AI
~302 spots leftby Jul 2026