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NCT02756195 · ClinicalTrials.gov registry record
The Impact of Non-Routine Events on Neonatal Safety
A clinical trial, sponsored by Vanderbilt University.
- Completed
- Registry status
- 395
- Enrollment target
NCT02756195: Completed study, sponsored by Vanderbilt University.
NCT02756195 is a clinical trial that has completed, run by Vanderbilt University. The registered enrollment target is 395 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02756195 has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- 395 participants
- Enrollment target
Study Summary
The study objective is to decrease neonatal mortality and morbidity by elucidating the etiology of system failures during perioperative care. In Aim 1 the investigators will use a novel event discovery method, based on the construct of the nonroutine event (NRE), to efficiently capture dysfunctional clinical microsystem attributes and potentially dangerous conditions. A NRE is defined as any event that is perceived by care providers or skilled observers as a deviation from optimal care based on the clinical situation. In Aim 2, the investigators will perform a comparative analysis of prospectively collected NRE data to the data collected by conventional event reporting methodologies. In Aim 3 the investigators will collaborate with Primary Children's Hospital (PCH) in Salt Lake City, UT to conduct practical pilot testing of tools and measures developed and refined in the first two Aims. Products from Aims 1 \& 2 will include: 1. a taxonomy of NREs and outcomes for perioperative neonates; 2. neonatal Comprehensive Open-Ended Non-routine Event Survey (NCONES) data collection tool; 3. comparisons of 5 established event reporting systems, including their rates, costs and benefits; and 4. a guide to prototype neonatal safety surveillance and risk prediction for hospitals and NICUs. Aim 3 will capitalize on PCH's robust network of NICUs, neonatologists, and patient-level outcome data to conduct a pilot implementation evaluation of the methods and tools developed and refined in Aims 1-2.
Primary Outcome
American College of Surgeons (ACS) NSQIP Pediatric is a nationally validated, risk-adjusted, outcomes-based approach to measure and improve the quality of surgical care for pediatric patients. It employs a prospective, peer-controlled, validated database to quantify 30-day, risk-adjusted surgical outcomes, which provide a valid comparison of outcomes among all hospitals in the program.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 395 participants |
| Start Date | 2016-11 |
| Est. Completion | 2022-01-31 |
What the finished NCT02756195 record still lists
NCT02756195 is an observational study that tracks outcomes without assigning an intervention. The registered 395 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02756195 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02756195 about?
NCT02756195 is a clinical study titled "The Impact of Non-Routine Events on Neonatal Safety". The study objective is to decrease neonatal mortality and morbidity by elucidating the etiology of system failures during perioperative care. In Aim 1 the investigators will use a novel event discovery method, based on the construct of the nonroutine event (NRE), to efficiently capture dysfunctiona...
What is the current status of trial NCT02756195?
This trial is currently completed. The enrollment target is 395 participants. The study started on 2016-11. Estimated completion is 2022-01-31.
Who is sponsoring clinical trial NCT02756195?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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