CoolCap Followup Study-Coordination of Participating Centers

Completed

Conditions studied: Neonatal Encephalopathy

In brief

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.

Key facts

Study ID

NCT00581581

Run by

University of Rochester

People needed

62

Starts

2007-09-01

Expected to finish

2009-10-01

Last updated by the study team

2013-03-08

Who can join

Age: 6 and older, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Lack of parental consent

Where it is running

• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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