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NCT01913340 · ClinicalTrials.gov registry record · Phase 1
Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT01913340: Completed Phase 1 study, sponsored by University of California, San Francisco.
NCT01913340 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01913340, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a baby's brain near the time of birth, may cause death or neurologic disability. Cooling therapy (hypothermia) provides some protection, but about half of affected infants still have a poor outcome. This clinical trial will determine if the drug erythropoietin, given with hypothermia, is safe to use as a treatment that may further reduce the risk of neurologic deficits after HIE.
Primary Outcome
The investigators will monitor organ function and adverse events until hospital discharge from the neonatal intensive care unit
Interventions
- DRUG Normal saline
- DRUG Erythropoietin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-09 |
| Phase | Phase 1 |
What the finished NCT01913340 record still lists
NCT01913340 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal saline is the first listed.
NCT01913340 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01913340 about?
NCT01913340 is a clinical study titled "Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)". Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a baby's brain near the time of birth, may cause death or neurologic disability. Cooling therapy (hypothermia) provides some protection, but about half of affected infants still have a poor outcome. This clinical ...
What is the current status of trial NCT01913340?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2013-09. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01913340?
The interventions under investigation include: Normal saline (DRUG), Erythropoietin (DRUG).
Who is sponsoring clinical trial NCT01913340?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01913340's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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