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临床试验/NCT01186627
NCT01186627Unknown不适用

Trial to Evaluate a Specified Type of Apgar (TEST-APGAR) Follow-Up Study

Technische Universität Dresden1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,500
试验地点
1

研究概览

简要总结

A specified version of the Apgar-Score, that can be used in newborns under resuscitation, was developed and its value to predict chronic damage in preterm infants will be tested.

详细描述

Specifications of the individual items of the original Apgar score were suggested. These specifications slightly changed the Apgars' perspective, but did not alter the number of its components. The specified Apgar should therefore be easily applicable to every delivery room around the world. As a result of these specifications, the Apgar score will not express the efforts of the infant but describe its condition, independently of the requirements needed to achieve this condition. The advantage of the proposed definitions is the applicability in all infants, regardless of resuscitative efforts or gestational age.

To validate the accuracy of the specified version to predict neonatal mortality and long term neurological outcome in preterm infants the present prospective, observational study is planned. The study will test the hypothesis that the specified APGAR-score predicts mortality and morbidity better at 2 years of age than the conventional Apgar-score. Furthermore, the predictive reliability of the specified Apgar can be improved in combination with perinatal data respectively with the expanded Apgar version of the AAP/ACOG.

The primary outcome "condition at 2 years of age" is composed of death and a major neurological deficit. In this case "neurological deficit" is defined by the presence of one of the followings characteristics: index of mental development (Bayley Scale II) <85, blindness, deafness, cerebral palsy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All preterm infants included in the TEST-APGAR Study

排除标准

  • Missing parental Consent

研究者

申办方类型
Other

研究点 (1)

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