The Impact of Non-Routine Events on Neonatal Safety
Public ClinicalTrials.gov record NCT02756195. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Impact of Non-Routine Events on Neonatal Safety in the Perioperative Environment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02756195
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 395 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2016
- Primary completion
- Jan 30, 2022
- Completion
- Jan 30, 2022
- Last update posted
- Apr 25, 2022
2016 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02756195, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 25, 2022 · Synced Sep 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02756195 live on ClinicalTrials.gov.