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Dietary Supplement

Human vs. Bovine Milk-Based Fortifiers for Preterm Infant Growth

N/A
Waitlist Available
Led By Belal Alshaikh, MD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Birthweight between 400 g-1250 g
Less than or 32 weeks gestational age at birth
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly for 8 weeks
Awards & highlights

Study Summary

This trial compared the growth of preterm infants receiving either a bovine milk-based or a human milk-based multi-nutrient HMF.

Who is the study for?
This trial is for preterm infants with a birthweight of 400-1250g, born at or before 32 weeks, and classified as appropriate for their gestational age. They must have started enteral feeding with human milk within 72 hours of birth and are expected to continue for at least three weeks. Infants with HIV treatment, exposure to maternal substance abuse during pregnancy, major surgery, or diseases affecting growth cannot participate.Check my eligibility
What is being tested?
The study tests two types of fortifiers added to human milk: one derived from humans and the other from cows. These supplements aim to fulfill the nutritional needs of very low birth weight (VLBW) preterm infants who can't get enough nutrients from human milk alone.See study design
What are the potential side effects?
Potential side effects may include digestive issues due to intolerance or allergic reactions related to the origin of the HMF (human vs bovine). However, specific side effects will depend on each infant's condition and response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My baby's birthweight was between 400 g and 1250 g.
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I was born at or before 32 weeks of pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly for 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly for 8 weeks for reporting.

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
Secondary outcome measures
Electrolytes abnormalities
Feed intolerance
Head circumference
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Bovine milk-derived HMFExperimental Treatment1 Intervention
Current standard practice: Fortification with bovine milk-derived product
Group II: Human milk-derived HMFActive Control1 Intervention
Fortification with human milk-derived product

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
791 Previous Clinical Trials
868,692 Total Patients Enrolled
Belal Alshaikh, MDPrincipal InvestigatorUniversity of Calgary
2 Previous Clinical Trials
130 Total Patients Enrolled

Media Library

Small for Gestational Age (SGA) Clinical Trial 2023: Human milk-derived HMF Highlights & Side Effects. Trial Name: NCT05228847 — N/A

Frequently Asked Questions

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

Is this research endeavor still accepting participants?

"According to clinicaltrials.gov, this research trial has ended its recruitment phase after being initially posted on January 15th 2023 and last updated November 4th 2022. Nevertheless, 28 other medical trials are still open for patient enrollment at the time of writing."

Answered by AI

What type of individuals are preferable to participate in this medical experiment?

"This trial is seeking 42 neonates between 3 days and 12 weeks of age, with a birthweight in the range 400 - 1250 g, who are classified as appropriate for gestational age and have necrotizing enterocolitis. Furthermore, these patients must be receiving human milk by 72 hours after birth and will need to maintain this diet for a minimum of three weeks."

Answered by AI

Are individuals aged 30 and beyond eligible to participate in this experiment?

"In accordance with the guidelines of this clinical trial, suitable candidates must range from 3 days to 12 weeks old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Human Milk-derived Fortification in Preterm Infants
Belal Alshaikh 2023. "Human Milk-derived Fortification in Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05228847.
~0 spots leftby Apr 2024
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