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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 is a clinical trial that has completed, run by Vanderbilt University. The registered enrollment target is 395 participants.

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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.

Trial Details

FieldValue
Enrollment Target 395 participants
Start Date 2016-11
Est. Completion 2022-01-31

Sponsor

Vanderbilt University

430 total trials

What the Registry Record Tells You About NCT02756195

The ClinicalTrials.gov registry entry for NCT02756195 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 395 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT02756195 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.