Cool Cap Long-term Follow-up Study

Protocol Description

This study assesses the long-term functional outcome of survivors from neonatal encephalopathy treated with either head cooling or with conventional care. Although it only occurs in approximately 3 out of 1000 full-term births, moderate to severe neonatal encephalopathy continues to be an important cause of acute neurologic injury at birth and subsequent long-term disability. A scientific study of head-cooling known as the “Cool Cap trial,” during the years 1999-2003 suggested that hypothermia was protective in the group of infants with moderately severe encephalopathy. However, one of the major factors limiting clinical adoption of head-cooling hypothermia was the lack of long-term follow-up.

Eligibility Criteria

Children, ages 7 and 8, of both genders who participated as neonates in the Cool Cap study at either Children’s Hospital of Pittsburgh of UPMC or Magee-Womens Hospital are eligible for participation.
Boys: Less than 7 days old
Girls: Less than 7 days old

Requirements

The only requirement is a telephone interview of parents of previously enrolled children who survived. The special WeeFIM® questionnaire determines the child’s current level of performance on a set of skills basic for daily functioning.
Visits: Not applicable
Duration: Not applicable

Status: Closed to Enrollment

Source(s) of Support

Olympic Medical subsidiary of Natus Medical, Inc.

Additional Information

Study description at National Institutes of Health

Primary Investigator

Toby Debra Yanowitz, MD

Contact Information

Toby Debra Yanowitz, MD
412-692-5030