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Completed Phase 3 Interventional Results available

Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants

ClinicalTrials.gov ID: NCT01534481

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.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 7:07 AM EDT

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.

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