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Randomized Controlled Trial Multicenter Study
Seven- to eight-year follow-up of the CoolCap trial of head cooling for neonatal encephalopathy.
- Ronnie Guillet, A David Edwards, Marianne Thoresen, Donna M Ferriero, Peter D Gluckman, Andrew Whitelaw, Alistair Jan Gunn, and CoolCap Trial Group.
- Department of Pediatrics, University of Rochester Medical Center, Rochester, New York, USA. ronnie_guillet@urmc.rochester.edu
- Pediatr. Res. 2012 Feb 1; 71 (2): 205-9.
IntroductionWe 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.ResultsWeeFIM 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).DiscussionFunctional 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.MethodsAll 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.
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