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Hypothermia During ECMO to Decrease Brain Injury

NCT01675388 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2014-11-18

No results posted yet for this study

Summary

Newborn infants with severe respiratory failure are treated with extracorporeal membrane oxygenation (ECMO), a modified form of cardiopulmonary bypass. These infants as at risk for brain injury as a result of hypoxia and blood flow changes in the brain prior to and during ECMO. The investigators propose a clinical trial of a novel treatment (cooling during ECMO) and novel diagnostic tool (advanced MRI techniques) that will lead to improved outcomes, early diagnosis and intervention for brain injury, decreased cost and duration of clinical trials, decrease in the burden of chronic neurologic disease and disability in society, thus improving the health and quality of life of these infants as they progress through childhood into adulthood.

Conditions

  • Neonatal Respiratory Failure

Interventions

OTHER

Hypothermia

Hypothermia to 33.5 deg C

Sponsors & Collaborators

  • Sood, Beena G., MD, MS

    lead INDIV

Principal Investigators

  • Beena G. Sood · Wayne State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01675388 on ClinicalTrials.gov