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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 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 50 participants.

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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.

Interventions

  • DRUG Normal saline
  • DRUG Erythropoietin

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2013-09
Est. Completion 2016-09
Phase Phase 1

What the Registry Record Tells You About NCT01913340

The ClinicalTrials.gov registry entry for NCT01913340 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Normal saline is the first listed.

NCT01913340 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.