N/A
Completed N=62
CoolCap Followup Study-Coordination of Participating Centers
Source: ClinicalTrials.gov NCT00581581 ↗Enrolled (actual)
62
Serious AEs
—
Results posted
Mar 2013
Primary outcomePrimary: WeeFIM Score — 78; 80 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY WeeFIM Score |
78; 80 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00581581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.