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Human Milk Derived Fortifier for Congenital Heart Defects

N/A
Waitlist Available
Led By Cynthia Blanco, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial will evaluate the benefits of an exclusive human milk diet for infants with single ventricle physiology.

Eligible Conditions
  • Congenital Heart Defects

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
growth velocity
Secondary outcome measures
Feeding Intolerance
Length of stay
Necrotizing enterocolitis
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Exclusive Human MilkExperimental Treatment1 Intervention
All infants randomized to this arm will receive exclusive human milk diet with addition of human milk derived fortifier from birth to 30 days post initiation of feedings after initial palliative cardiac surgery
Group II: Human/Bovine MilkActive Control1 Intervention
All infants randomized to this arm will receive exclusive human milk diet prior to randomization and will use either human and/or bovine milk and fortifier per the institution's standard practice 30 days post initiation of feedings after initial palliative cardiac surgery

Find a Location

Who is running the clinical trial?

University of OklahomaOTHER
455 Previous Clinical Trials
97,594 Total Patients Enrolled
Columbia UniversityOTHER
1,432 Previous Clinical Trials
2,460,957 Total Patients Enrolled
University of FloridaOTHER
1,340 Previous Clinical Trials
715,689 Total Patients Enrolled

Frequently Asked Questions

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

How many medical centers are engaged in this investigation?

"This clinical trial is utilizing the medical facilities at University of Texas Southwestern Medical Center in Dallas, Loma Linda University in California and Texas Children's Hospital in Houston as well as 10 other sites."

Answered by AI

Are any new participants being enrolled for this experiment?

"This trial, which was posted on the 1st of July 2016 and most recently modified October 10th 2022, is not presently recruiting. Fortunately, there are other 108 studies actively accepting participants currently listed on clinicaltrials.gov."

Answered by AI

What are the eligibility requirements for participation in this trial?

"This clinical investigation is looking to enrol 16 neonates with congenital heart malformations, ranging from day-old infants up to 7 days old. Applicants must satisfy the following requirements: Have a gestational age of at least 37 weeks 0/7; Be fed by either only mothers' milk or nothing prior to enrollment; Allow parental consent for the trial and compliance with follow-up protocols; Require their single ventricle defect be palliated surgically within one month of birth."

Answered by AI

Does the age requirement for this medical trial cap at 45 years old?

"As stated in the study requirements, infants between 1 and 7 days old are eligible to take part."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology
2016. "Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02860702.
~2 spots leftby Apr 2025
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