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Human Milk Fortifier

Human Milk Fortifier for Growth in Preterm Infants

N/A
Waitlist Available
Research Sponsored by Abbott Nutrition
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 study day 1, 8, 15, 22, 29 and hospital discharge
Awards & highlights

Study Summary

This trial will test whether adding human milk fortifier to preterm infant's milk helps them grow and doesn't cause any negative side effects.

Who is the study for?
This trial is for preterm infants with a birth weight of 700g-1500g, born at ≤32 weeks gestation, and classified as appropriate for their gestational age. They must start human milk feeding by day 21 of life. Only single or twin births qualify, and parents must consent to exclusive human milk fortified with the study product.Check my eligibility
What is being tested?
The study tests two types of human milk fortifier (HMF) to see which one supports better growth in preterm infants. It's a double-blind trial meaning neither the researchers nor participants know who gets which HMF, ensuring unbiased results.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include digestive issues or intolerance related to the experimental HMF compared to the control product. Close monitoring will identify any adverse reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study day 1, 8, 15, 22, 29 and hospital discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and study day 1, 8, 15, 22, 29 and hospital discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Lactose Intolerance
Full Enteral Feeds
Head Circumference
+4 more
Other outcome measures
Adverse Events
Blood Chemistries
Blood Sample for Immunity/Inflammation
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Product 2Experimental Treatment1 Intervention
Study Human Milk Fortifier added to human milk feedings
Group II: Product 1Experimental Treatment1 Intervention
Study Human Milk Fortifier added to human milk feedings
Group III: Control ProductActive Control1 Intervention
Control Human Milk Fortifier added to human milk feedings

Find a Location

Who is running the clinical trial?

Abbott NutritionLead Sponsor
167 Previous Clinical Trials
33,163 Total Patients Enrolled
3 Trials studying Growth
1,160 Patients Enrolled for Growth
Bridget Barrett Reis, PhD, RDStudy ChairAbbott Nutrition
2 Previous Clinical Trials
805 Total Patients Enrolled
1 Trials studying Growth
637 Patients Enrolled for Growth
Elizabeth Reverri, PhD, MS, RDStudy ChairAbbott Nutrition
1 Previous Clinical Trials
45 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available slots for participants in this research?

"Clinicaltrials.gov confirms that this particular medical study is not actively recruiting at the moment; however, it was posted on May 1st 2023 and last modified October 26th 2022. Fortunately, there are 7 other clinical trials looking for participants presently."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Preterm Infants Fed a Human Milk Fortifier
2024. "Preterm Infants Fed a Human Milk Fortifier". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05551975.
~214 spots leftby Jan 2028
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