Clinical trial NCT00581581: CoolCap Followup Study-Coordination of Participating Centers
Official title: Long-term Follow-up After Head Cooling for Neonatal Encephalopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Encephalopathy
Keywords: neonatal encephalopathy
therapeutic hypothermia
head cooling
neonatal asphyxia
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Olympic Medical
First posted: 2007-12-27
Enrollment: 62
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible children will be those who participated in the original randomized clinical trial, "Brain Cooling for the Treatment of Perinatal Hypoxic-Ischemic Encephalopathy". Infants enrolled in that study were randomized to cooling or standard care. Survivors to 7-8 years of age are eligible for this observational followup study.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Previous participation in the CoolCap study
* Survivors to 7-8 years of age
* Parental consent to participation

Exclusion Criteria:

* Lack of parental consent

Primary outcomes:
measure: WeeFIM Score
timeFrame: 7-8 years after initial intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Ronnie Guillet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gluckman PD, Wyatt JS, Azzopardi D, Ballard R, Edwards AD, Ferriero DM, Polin RA, Robertson CM, Thoresen M, Whitelaw A, Gunn AJ. Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomised trial. Lancet. 2005 Feb 19-25;365(9460):663-70. doi: 10.1016/S0140-6736(05)17946-X.
citation: Guillet R, Edwards AD, Thoresen M, Ferriero DM, Gluckman PD, Whitelaw A, Gunn AJ; CoolCap Trial Group. Seven- to eight-year follow-up of the CoolCap trial of head cooling for neonatal encephalopathy. Pediatr Res. 2012 Feb;71(2):205-9. doi: 10.1038/pr.2011.30. Epub 2011 Dec 21.