Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology
Public ClinicalTrials.gov record NCT02860702. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Controlled Trial to Evaluate Growth Velocity and Clinical Outcomes of Infants With Single Ventricle Physiology Fed an Exclusive Human Milk Diet With Early Nutritional Fortification Following Surgical Repair
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A randomized, blinded, controlled trial to evaluate growth velocity and clinical outcomes in infants with single ventricle physiology fed an exclusive human milk diet prior to, and throughout the post-operative period following, surgical repair. Human milk is defined as expressed human milk or donor milk and its derivatives, human milk-based fortifier and human milk caloric fortifier. The study hypothesis is that infants fed an exclusive human milk diet will have short and long term benefits, with improved wound healing, growth, and neurodevelopmental outcomes while reducing episodes of feeding intolerance and necrotizing enterocolitis (NEC).
Study identification
- NCT ID
- NCT02860702
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 16 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Day to 7 Days
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2016 (Actual)
- Primary completion
- Dec 31, 2020 (Actual)
- Completion
- Oct 6, 2022 (Actual)
- Last update posted
- Sep 26, 2023
2016 – 2022
United States locations
- U.S. sites
- 12
- U.S. states
- 7
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92354 | — |
| Los Angeles Children's Hospital | Los Angeles | California | 90027 | — |
| Children's Hospital Orange County | Orange | California | 92868 | — |
| University of Florida Children's Hospital | Gainesville | Florida | 32610 | — |
| Lurie Children's Hospital | Chicago | Illinois | 60611 | — |
| Columbia University | New York | New York | 10027 | — |
| Cincinatti Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| OU Children's Hospital at OU Medical Center | Oklahoma City | Oklahoma | 73104 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Cook Children's Medical | Fort Worth | Texas | 76104 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| University Health System | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02860702, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 26, 2023 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02860702 live on ClinicalTrials.gov.