Cool Cap Long-term Follow-up Study

Neurodevelopmental Outcome at Age 7 After Selective Head Cooling with Mild Systemic Hypothermia After Neonatal Encephalopathy

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


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.

Primary Investigator

Toby Debra Yanowitz, MD

Contact Information

Toby Debra Yanowitz, MD