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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 belowSelect...
My baby was born weighing 1250 grams or less.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18-24 months ca
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18-24 months ca
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 moreOther outcome measures
Body composition at follow-up
Brain--connectivity
Brain--event related potentials
+4 moreTrial 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
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My baby was born weighing 1250 grams or less.My infant has a condition that could affect their growth.
Research Study Groups:
This trial has the following groups:- Group 1: Standard fortification
- Group 2: Target fortification
- Group 3: BUN adjustable fortification
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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