Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
Public ClinicalTrials.gov record NCT01534481. 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
Neurodevelopmental Effects of Donor Human Milk vs. Preterm Formula in Extremely Low Birth Weight (ELBW) Infants
Study identification
- NCT ID
- NCT01534481
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- NICHD Neonatal Research Network
- Network
- Enrollment
- 483 participants
Conditions and interventions
Interventions
- Donor Milk Biological
- Preterm Formula Dietary Supplement
Biological · Dietary Supplement
Eligibility (public fields only)
- Age range
- Up to 21 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 31, 2012
- Primary completion
- Nov 29, 2021
- Completion
- Nov 29, 2021
- Last update posted
- Jul 15, 2026
2012 – 2021
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Stanford University | Palo Alto | California | 94304 | — |
| Emory University | Atlanta | Georgia | 30303 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Wayne State University | Detroit | Michigan | 48201 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| RTI International | Durham | North Carolina | 27705 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | — |
| Research Institute at Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Brown University, Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | — |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | — |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
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 NCT01534481, 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 Jul 15, 2026 · Synced Jul 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01534481 live on ClinicalTrials.gov.