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CoolCap Followup Study-Coordination of Participating Centers

NCT00581581 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 62

Last updated 2013-03-08

Study results available
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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.

Conditions

  • Neonatal Encephalopathy

Sponsors & Collaborators

  • Olympic Medical

    collaborator INDUSTRY

  • University of Rochester

    lead OTHER

Principal Investigators

  • Ronnie Guillet, MD, PhD · University of Rochester

Eligibility

Min Age
6 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-10-31
Completion
2009-10-31

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 NCT00581581 on ClinicalTrials.gov