CoolCap Followup Study-Coordination of Participating Centers
|ClinicalTrials.gov Identifier: NCT00581581|
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : March 8, 2013
Last Update Posted : March 8, 2013
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||62 participants|
|Observational Model:||Case Control|
|Official Title:||Long-term Follow-up After Head Cooling for Neonatal Encephalopathy|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
Randomized to cooling (original randomized clinical trial): All children, now 6-8 years old who were randomized to cooling in the original trial were included in this arm. Cooling was achieved via the CoolCap system (Olympic Medical/Natus Corporation) in these babies.
Randomized to standard care (original randomized clinical trial): All children, now 6-8 years old, who were treated using the standard of care at the time (normal temperature) were included in this arm. Infants' temperatures were monitored per standard of care. Most infants were cared for on an open wamer that was servo-controlled to normal body temperature (37 C) or in a standard bassinette.
- WeeFIM Score [ Time Frame: 7-8 years after initial intervention ]WeeFIM instrument (the Functional Independence Measure for Children, Uniform Data System for Medical Rehabilitation, Buffalo, NY) is a set of ratings of 18 skills divided into 3 general domains: 8 Self-care; 5 Mobility; 5 Cognition. Caregivers rate a child about extent of independence, full functioning, in carrying out each of those 18 skills, on a scale from "1" for total assistance, total dependence, maximal prompting, or not testable to "7" for complete independence. The ratings are combined to yield 3 Domain scores and a WeeFIM Total. Favorable=mean+/-2SD. We are reporting the percentage of participants with a favorable response.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581581
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Ronnie Guillet, MD, PhD||University of Rochester|