NCT00581581

CoolCap Followup Study-Coordination of Participating Centers

Long-term Follow-up After Head Cooling for Neonatal Encephalopathy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 62 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 6 Years – 8 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Neonatal Encephalopathy

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2007-12-27
• Last updated: 2013-03-08
• Results posted: 2013-03-08

Locations

1 site across 1 country: United States