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NCT01421238 · ClinicalTrials.gov registry record · NA
Framing and Decision Making in Neonatology
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 350
- Enrollment target
NCT01421238: Completed NA study, sponsored by Columbia University.
NCT01421238 is a NA study that has completed, run by Columbia University. The registered enrollment target is 350 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01421238, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 350 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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
Interventions
- BEHAVIORAL Survey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2006-05 |
| Est. Completion | 2007-04 |
| Phase | NA |
What the finished NCT01421238 record still lists
NCT01421238 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which Survey is the first listed.
NCT01421238 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01421238 about?
NCT01421238 is a clinical study titled "Framing and Decision Making in Neonatology". 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 ad...
What is the current status of trial NCT01421238?
This trial is currently completed. It is a NA study. The enrollment target is 350 participants. The study started on 2006-05. Estimated completion is 2007-04.
What interventions are being tested in trial NCT01421238?
The interventions under investigation include: Survey (BEHAVIORAL).
Who is sponsoring clinical trial NCT01421238?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01421238's enrollment target sits among peer trials
350 292nd of 2000 higher than 1,699 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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