← Back to Search

Human Milk Fortifier

Observational Case for Growth Delay

N/A
Waitlist Available
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Complex congenital heart disease in presence of poor linear and head circumference growth and unable to tolerate cow's milk protein
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 6 months
Awards & highlights
No Placebo-Only Group

Summary

A single patient observational trial to evaluate growth velocity and clinical outcomes of an infant status post cardiac surgery who has failed to grow well and demonstrated intolerance to cow milk-based and elemental formulas and fortifiers on a 100% human milk diet including a human milk based human milk fortifier formulated for term infants fluid restricted due to surgically correctable congenital conditions.

Eligible Conditions
  • Growth Delay

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Growth
Secondary study objectives
Head circumference growth
Linear growth

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: Observational CaseExperimental Treatment1 Intervention
1 infant will be enrolled as an observational case. Will receive an exclusive human milk diet at home.

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
374 Previous Clinical Trials
86,174 Total Patients Enrolled
Prolacta BioscienceIndustry Sponsor
16 Previous Clinical Trials
1,577 Total Patients Enrolled
~0 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top