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Completed Not applicable Interventional

CoolCap Trial, Treatment of Perinatal Hypoxic-Ischemic Encephalopathy

ClinicalTrials.gov ID: NCT00383305

Public ClinicalTrials.gov record NCT00383305. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 6:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Brain-Cooling for the Treatment of Perinatal Hypoxic-Ischemic Encephalopathy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a research study of head cooling. Its goal is to determine whether cooling babies' heads can reduce or prevent brain damage that may have resulted from temporarily reduced oxygen supply to the brain. In this study, half of the babies (selected at random) will have a special cooling cap with circulating water placed on their head for 72 hours to lower the temperature of their brain. The rest of the baby's body will be maintained at a defined temperature by a standard overhead radiant heater. The study protocol includes the taking and analysis of blood samples, performance of brain wave tests, imaging of the brain by ultrasound, and other tests as clinically indicated. Neurodevelopmental outcome will also be assessed at 18 months of age.

Study identification

NCT ID
NCT00383305
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Olympic Medical
Industry
Enrollment
235 participants

Conditions and interventions

Eligibility (public fields only)

Age range
1 Hour to 6 Hours
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 1999 (Type not available)
Primary completion
Not listed
Completion
Sep 2003 (Type not available)
Last update posted
Oct 3, 2006

1999 – 2003

United States locations

U.S. sites
19
U.S. states
12
U.S. cities
18
Facility City State ZIP Site status
Arkansas Children's Hospital Little Rock Arkansas 72202 —
Children's Hospital and Research Center at Oakland Oakland California 94609 —
University of California San Diego Medical Center (Hillcrest) San Diego California 92103 —
University of California San Francisco Children's Hospital San Francisco California 94110 —
Children's Hospital of Denver Denver Colorado 80262 —
Children's Memorial Hospital / Prentice Women's Hospital Chicago Illinois 60611 —
University of Illinois at Chicago Medical Center Chicago Illinois 60612 —
Johns Hopkins University Baltimore Maryland 21287 —
University of Michigan Medical Center - Mott Children's Hospital Ann Arbor Michigan 48109 —
Children's Hospital and Clinics of Minneapolis Minneapolis Minnesota 55404 —
Schneider Children's Hospital New Hyde Park New York 11040 —
Children's Hospital of new York - Presbyterian (Columbia University) New York New York 10032 —
Golisano Children's Hospital at Strong Rochester New York 14642 —
Duke University Medical Center Durham North Carolina 27705 —
Wake Forest University Baptist Medical Center Winston-Salem North Carolina 27157 —
Children's Hospital of Oklahoma Oklahoma City Oklahoma 73190 —
AI Dupont Children's Hospital at Thomas Jefferson University Medical Center Philadelphia Pennsylvania 19107 —
Magee Women's Hospital / Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15213 —
Vanderbilt University Medical Center Nashville Tennessee 37232 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00383305, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 3, 2006 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00383305 live on ClinicalTrials.gov.

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