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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
No Placebo-Only Group

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.
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.
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

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

Awards & Highlights

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

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
170 Previous Clinical Trials
33,347 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
~214 spots leftby Jan 2028
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