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Dietary Supplement
Milk Fortification Methods for Preterm Infants' Growth (FAT Trial)
N/A
Recruiting
Led By Belal Alshaikh, MD, MSc
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 36 weeks ca
Awards & highlights
FAT Trial Summary
This trial will compare two methods of fortifying human milk for preterm infants. The first group will receive targeted fortification, and the second group will receive adjustable fortification.
Who is the study for?
This trial is for preterm infants born weighing less than 1250 grams and considered appropriate for their gestational age. They must be born at Foothills Medical Centre without major congenital anomalies, acute kidney injury, prior NEC, confirmed TORCH infections or abnormal newborn metabolic screen results.Check my eligibility
What is being tested?
The study is testing whether targeted fortification of human milk leads to better weight gain in preterm infants under 1250g compared to adjustable fortification. It's an open-label randomized controlled trial with two parallel groups.See study design
What are the potential side effects?
Since the interventions involve human milk fortification methods rather than drugs, typical drug side effects are not expected. However, monitoring will be necessary to ensure optimal growth and detect any potential feeding intolerance.
FAT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 36 weeks ca
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 36 weeks ca
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average weight gain in infants on Adjustable versus Targeted human milk fortification
Secondary outcome measures
Anthropometrics in infants on Adjustable versus Targeted human milk fortification
BUN concentration in infants on Adjustable versus Targeted human milk fortification
Incidence of extra uterine growth restriction
FAT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Targeted Human Milk FortificationExperimental Treatment1 Intervention
Human milk fortification based on milk analysis
Group II: Adjustable Human Milk FortificationActive Control1 Intervention
Human milk fortification based on blood urea levels
Find a Location
Who is running the clinical trial?
University of CalgaryLead Sponsor
791 Previous Clinical Trials
868,682 Total Patients Enrolled
Belal Alshaikh, MD, MScPrincipal InvestigatorUniversity of Calgary
3 Previous Clinical Trials
508 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You were born with a major birth defect that requires ongoing medical treatment or surgery.I have been diagnosed with a TORCH infection.I have acute kidney injury.I developed NEC before joining the study.I am currently taking steroids in the form of pills, injections, or infusions.
Research Study Groups:
This trial has the following groups:- Group 1: Adjustable Human Milk Fortification
- Group 2: Targeted Human Milk 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 there still opportunities available for participants in this study?
"Based on the latest update from clinicaltrials.gov, this specific medical trial is not presently recruiting new patients; it was initially posted in March of 2023 and last modified in November of 2022. However, there are currently 12 other studies that are actively enrolling participants for their trials."
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