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| Sponsors and Collaborators: |
University of Rochester Olympic Medical |
|---|---|
| Information provided by: | University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00581581 |
Purpose
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.
| Condition |
|---|
|
Neonatal Encephalopathy |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | Long-Term Follow-up After Head Cooling for Neonatal Encephalopathy |
| Estimated Enrollment: | 140 |
| Study Start Date: | September 2007 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Randomized to cooling (original RCT)
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2
Randomized to standard care (original RCT)
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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| Ages Eligible for Study: | 6 Years to 8 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Eligible children will be those who participated in the original RCT, "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.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| Principal Investigator: | Ronnie Guillet, MD, PhD | University of Rochester |
More Information
| Responsible Party: | University of Rochester ( Ronnie Guillet ) |
| Study ID Numbers: | RSRB00020479 |
| Study First Received: | December 21, 2007 |
| Last Updated: | December 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00581581 |
| Health Authority: | United States: Institutional Review Board |
|
neonatal encephalopathy therapeutic hypothermia head cooling neonatal asphyxia |
|
Asphyxia Neonatorum Liver Diseases Neurotoxicity Syndromes Brain Damage, Chronic Disorders of Environmental Origin Brain Diseases Signs and Symptoms Mental Disorders Asphyxia neonatorum Brain Injuries Dementia Neurobehavioral Manifestations Delirium Hepatic Insufficiency Hypothermia |
Liver Failure Metabolic Diseases Neurotoxicity syndromes Poisoning Central Nervous System Diseases Confusion Encephalitis Cognition Disorders Virus Diseases Hepatic Encephalopathy Delirium, Dementia, Amnestic, Cognitive Disorders Digestive System Diseases Central Nervous System Infections Neurologic Manifestations Metabolic disorder |
|
Nervous System Diseases Central Nervous System Viral Diseases |
