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Transfusion of Prematures Trial
NCT01702805 · View on ClinicalTrials.gov ↗
Study Summary
The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26 months of age, using standardized assessments by Bayley.
Conditions Studied
Interventions
- PROCEDURE Liberal Cell Transfusion
- PROCEDURE Restricted red cell transfusion
Study Locations (20)
Ohio
- Cincinnati Children's Medical Center — Cincinnati
- Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland
- Research Institute at Nationwide Children's Hospital — Columbus
California
- University of California - Los Angeles — Los Angeles
- Stanford University — Palo Alto
North Carolina
- RTI International — Durham
- Duke University — Durham
Texas
- University of Texas Southwestern Medical Center at Dallas — Dallas
- University of Texas Health Science Center at Houston — Houston
Alabama
- University of Alabama at Birmingham — Birmingham
Georgia
- Emory University — Atlanta
Indiana
- Indiana University — Indianapolis
Iowa
- University of Iowa — Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,824 participants |
| Start Date | 2012-12 |
| Est. Completion | 2025-04-29 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01702805
The ClinicalTrials.gov registry entry for NCT01702805 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,824 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Neonatal Research Network, which has 44 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Anemia appearing as the primary indexed condition, and to 2 interventions — of which Liberal Cell Transfusion is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01702805 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Ohio, California, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01702805 about?
NCT01702805 is a clinical study titled "Transfusion of Prematures Trial". The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26 months of age, using standardized as...
What is the current status of trial NCT01702805?
This trial is currently completed. It is a NA study. The enrollment target is 1,824 participants. The study started on 2012-12. Estimated completion is 2025-04-29.
What conditions does trial NCT01702805 study?
This clinical trial studies the following conditions: Anemia, Infant, Small for Gestational Age, Infant, Newborn, Diseases, Bronchopulmonary Dysplasia (BPD), Infant, Extremely Low Birth Weight. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01702805?
The interventions under investigation include: Liberal Cell Transfusion (PROCEDURE), Restricted red cell transfusion (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01702805?
This trial is sponsored by NICHD Neonatal Research Network, which has 44 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01702805 being conducted?
This trial has 20 study locations across Alabama, California, Georgia, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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