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CoolCap Followup Study-Coordination of Participating Centers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00581581
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : March 8, 2013
Last Update Posted : March 8, 2013
Olympic Medical
Information provided by (Responsible Party):
Ronnie Guillet, University of Rochester

Brief Summary:
This observational study will assess long-term functional outcome of survivors from neonatal encephalopathy who were previously treated with either head cooling or with conventional care in a randomized clinical trial. Children's parents will be interviewed by phone by trained staff using the WeeFIM questionnaire to ascertain the childrens' functional performance on a set of skills basic to daily life. This instrument is able to assess a very wide range of abilities, from independently functioning to needing total assistance. The ratings will be used to examine the relationship between the outcome previously measured at 18 months age and functional outcome at school age and to triage the children into those who clearly could not be tested on standardized exams of cognitive functioning, those who potentially could, even if at a low level of cognitive ability, and those who appear to be functioning at an age-appropriate level.

Condition or disease
Neonatal Encephalopathy

Detailed Description:
Previous studies have demonstrated that hypothermia for hypoxic-ischemic encephalopathy in the neonatal period is generally safe and feasible, and can improve intermediate term survival without handicap. There is, however, no information on whether cooling improves longer term (school-age) outcomes in non-handicapped survivors. The current observational trial is designed to help obtain additional followup information on children who participated in the initial randomized clinical trial of head-cooling for neonatal encephalopathy. A first step is to collect information on the current status (at 7-8 years of age) of participants in the original study using a standardized telephone questionnaire. This will allow the investigators to more appropriately target children for whom further, more detailed, in-person neurodevelopmental testing would be appropriate. Given limited resources, identification of children for whom such testing would be helpful and instructive is a necessary goal.

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Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Long-term Follow-up After Head Cooling for Neonatal Encephalopathy
Study Start Date : September 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Randomized to cooling (original randomized clinical trial): All children, now 6-8 years old who were randomized to cooling in the original trial were included in this arm. Cooling was achieved via the CoolCap system (Olympic Medical/Natus Corporation) in these babies.
Randomized to standard care (original randomized clinical trial): All children, now 6-8 years old, who were treated using the standard of care at the time (normal temperature) were included in this arm. Infants' temperatures were monitored per standard of care. Most infants were cared for on an open wamer that was servo-controlled to normal body temperature (37 C) or in a standard bassinette.

Primary Outcome Measures :
  1. WeeFIM Score [ Time Frame: 7-8 years after initial intervention ]
    WeeFIM instrument (the Functional Independence Measure for Children, Uniform Data System for Medical Rehabilitation, Buffalo, NY) is a set of ratings of 18 skills divided into 3 general domains: 8 Self-care; 5 Mobility; 5 Cognition. Caregivers rate a child about extent of independence, full functioning, in carrying out each of those 18 skills, on a scale from "1" for total assistance, total dependence, maximal prompting, or not testable to "7" for complete independence. The ratings are combined to yield 3 Domain scores and a WeeFIM Total. Favorable=mean+/-2SD. We are reporting the percentage of participants with a favorable response.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible children will be those who participated in the original randomized clinical trial, "Brain Cooling for the Treatment of Perinatal Hypoxic-Ischemic Encephalopathy". Infants enrolled in that study were randomized to cooling or standard care. Survivors to 7-8 years of age are eligible for this observational followup study.

Inclusion Criteria:

  • Previous participation in the CoolCap study
  • Survivors to 7-8 years of age
  • Parental consent to participation

Exclusion Criteria:

  • Lack of parental consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00581581

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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Olympic Medical
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Principal Investigator: Ronnie Guillet, MD, PhD University of Rochester
Publications of Results:
Other Publications:
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Responsible Party: Ronnie Guillet, Professor, University of Rochester Identifier: NCT00581581    
Other Study ID Numbers: RSRB00020479
First Posted: December 27, 2007    Key Record Dates
Results First Posted: March 8, 2013
Last Update Posted: March 8, 2013
Last Verified: March 2013
Keywords provided by Ronnie Guillet, University of Rochester:
neonatal encephalopathy
therapeutic hypothermia
head cooling
neonatal asphyxia
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases