Seven- to eight-year follow-up of the CoolCap trial of head cooling for neonatal encephalopathy.

INTRODUCTION: We sought to determine whether 18- to 22-mo neurodevelopmental outcomes predicted functional outcomes at 7-8 y for survivors of the CoolCap study of therapeutic hypothermia for neonates with hypoxic-ischemic encephalopathy.

RESULTS: WeeFIM ratings were completed at 7-8 y of age on 62 (32 cooled; 30 standard care) of 135 surviving children who had had neurodevelopmental assessment at 18 mo. There was 1 refusal, 58 lost to follow-up, and 14 children whose centers declined to participate. Disability status at 18 mo was strongly associated with WeeFIM ratings (P < 0.001); there was no significant effect of treatment (P = 0.83).

DISCUSSION: Functional outcome at 7-8 y of survivors of neonatal encephalopathy is associated with 18-mo neurodevelopmental assessment, supporting the long-term predictive value of a favorable outcome at 18 mo assessed by published trials of therapeutic hypothermia.

METHODS: All surviving children who participated in the CoolCap study and were assessed at 18 mo were eligible for reassessment using the WeeFIM instrument that qualitatively measures self-care, mobility, and cognitive function. Center investigators obtained consent from the families for a certified researcher to administer the WeeFIM instrument by phone.