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NCT02482012 · ClinicalTrials.gov registry record
Minor Increase Over Minimal Risk Research in NICU
A clinical trial, sponsored by Christiana Care Health Services.
- Completed
- Registry status
- 96
- Enrollment target
NCT02482012: Completed study, sponsored by Christiana Care Health Services.
NCT02482012 is a clinical trial that has completed, run by Christiana Care Health Services. The registered enrollment target is 96 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02482012 has completed, sponsored by Christiana Care Health Services.
- COMPLETED
- Registry status
- 96 participants
- Enrollment target
Study Summary
Infants comprise a potentially vulnerable research population that received special consideration and protections under the US Code of Federal Regulations - Subpart D. Of the four categories of research involving children, 45 CFR 46.406 is of particular interest to researchers, ethicists, parents, and clinical staff members since it concerns the conduct of research with "more than minimal risk" without the prospect of direct benefit. Parents are the surrogate decision makers for infants. When asked about this type of research in studies pertaining to older infants and children, parent themes include: concerns of medical research and research-related risk, desire to advance generalizable medical knowledge and knowledge specific to their own child's disease. There are no data on parents' perceptions regarding this category of research that target the premature, late-preterm and term newborn populations. This study involves a questionnaire for both staff (nurses and physicians) and parents. The questionnaire represented 4 different infant scenarios in a random order. Respondents are asked to answer questions related to enrollment in a research study for each of the 4 scenarios.
Primary Outcome
This is a survey to determine attitudes / willingness to participate in a specific category of research.
Interventions
- OTHER Survey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2014-06 |
| Est. Completion | 2015-05 |
What the finished NCT02482012 record still lists
NCT02482012 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 96 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Survey is the first listed.
NCT02482012 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02482012 about?
NCT02482012 is a clinical study titled "Minor Increase Over Minimal Risk Research in NICU". Infants comprise a potentially vulnerable research population that received special consideration and protections under the US Code of Federal Regulations - Subpart D. Of the four categories of research involving children, 45 CFR 46.406 is of particular interest to researchers, ethicists, parents, a...
What is the current status of trial NCT02482012?
This trial is currently completed. The enrollment target is 96 participants. The study started on 2014-06. Estimated completion is 2015-05.
What interventions are being tested in trial NCT02482012?
The interventions under investigation include: Survey (OTHER).
Who is sponsoring clinical trial NCT02482012?
This trial is sponsored by Christiana Care Health Services, which has 82 total clinical trials registered on ClinicalTrials.gov.
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