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临床试验/NCT00581581
NCT00581581已完成不适用

Long-term Follow-up After Head Cooling for Neonatal Encephalopathy

University of Rochester1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
WeeFIM Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
6 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Lack of parental consent

结局指标

主要结局

WeeFIM Score

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ronnie Guillet

Professor

University of Rochester

研究点 (1)

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