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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
Must not have
Patients with confirmed congenital Toxoplasmosis, Syphilis, Rubella, Cytomegalovirus, Herpes simplex virus, Varicella and/or Zika (TORCH infections).
Patients with acute kidney injury (AKI).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 36 weeks ca
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a TORCH infection.
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I have acute kidney injury.
Select...
I developed NEC before joining the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 36 weeks ca
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 36 weeks ca for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average weight gain in infants on Adjustable versus Targeted human milk fortification
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
811 Previous Clinical Trials
889,524 Total Patients Enrolled
Belal Alshaikh, MD, MScPrincipal InvestigatorUniversity of Calgary
3 Previous Clinical Trials
508 Total Patients Enrolled

Media Library

Adjustable Human Milk Fortification (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04809350 — N/A
Growth Delay Research Study Groups: Adjustable Human Milk Fortification, Targeted Human Milk Fortification
Growth Delay Clinical Trial 2023: Adjustable Human Milk Fortification Highlights & Side Effects. Trial Name: NCT04809350 — N/A
Adjustable Human Milk Fortification (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04809350 — N/A
~25 spots leftby Dec 2025
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