MedTrace Logo

Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy

NCT00620711 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2019-01-29

Study results available
· View outcomes & findings →

Summary

The hypothesis is that premature infants' can have enough cooling applied to cool their brain to decrease CNS injury without cooling their body.

Conditions

  • Hypoxic Ischemic Encephalopathy

Interventions

DEVICE

Olympic Cool Cap

Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE.

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Willaim F Walsh, MD · Vanderbilt University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Minutes
Max Age
6 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00620711 on ClinicalTrials.gov