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临床试验/NCT01421238
NCT01421238已完成不适用

Framing and Perinatal Decision Making at Extremes of Prematurity

Columbia University1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2006年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
350
试验地点
1
主要终点
Number of participants deciding to resuscitate an extremely premature infant.

研究概览

简要总结

The purpose of this study is to study how people make decisions regarding delivery room management for infants born extremely premature when survival and long term outcomes are uncertain. The hypothesis is that the way in which information is presented will impact decisions.

There have been many advances in neonatal care in recent decades. However, the investigators do not know if these children will grow up to be healthy or if they will have problems with mental retardation, behavior or physical handicaps. In these circumstances, where the medical profession cannot predict what sort of life a child will have, parents have a choice of having intensive care started or of allowing the baby to die naturally. The age most often cited by physicians at which this care is optional and under parental discretion is 23 weeks gestation.

The purpose of this study was to ask people, recruited through the world wide web, what they would want for the doctor to do in the case of a hypothetical 23 week premature delivery in order to evaluate the decision process and the presence of autonomous choice. This study had two parts. The first part, presented outcome information in 2 different ways -either as survival and lack of severe disability or as mortality and presence of severe disability. The results of the first part have been published (Message Framing and Perinatal Decisions, Pediatrics, 2008). The second part, investigated whether the way in which the way in which delivery room management options were presented- either as agreeing with a course of action or opting out- impacted resuscitation decisions. This part was administered as a separate survey to a different sample of participants at a later date. The remainder of the questionnaires asked demographic and opinion questions as a means to assess variables that may influence how people respond to the information they receive.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Resuscitation Default Arm

Experimental

After receiving a description of an impending delivery of a 23 week gestational infant, participants in this arm were presented with the following information:

The doctor goes on to say that at this hospital infants born at 23 weeks will receive resuscitation, unless their parents object. If you decline resuscitation please check the box below:

Please check if you decline resuscitation []

干预措施: Survey (Behavioral)

Comfort Care Default Arm

Experimental

After receiving a description of an impending delivery of a 23 week gestational infant, participants in this arm were presented with the following information:

The doctor goes on to say that at this hospital infants born at 23 weeks will receive comfort care, unless their parents object. If you decline comfort care please check the box below:

Please check if you decline comfort care []

干预措施: Survey (Behavioral)

结局指标

主要结局

Number of participants deciding to resuscitate an extremely premature infant.

时间窗: Up to 1 year from the start of the study

Each participants decisional outcome (resuscitation or comfort care) per survey arm will be counted. We expect 60% of the participants will decide to resuscite in both arms. We expect that 90% will select resuscitation in those who receive the resuscitation default and 60% will select resuscitation in the comfort care default

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

Elke U. Weber

Jerome A. Chazen Professor of International Business and Professor of Psychology

Columbia University

研究点 (1)

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