SEPREVEN: a Stepped-wedge Randomised Controlled Trial — SEPREVEN  

Intubation Complication Clinical Trial

Official title: Study on Preventing Adverse Events in Neonates (SEPREVEN): a Stepped-wedge Randomised Controlled Trial to Reduce Adverse Event Rates in the NICU

Status Completed

Clinical Trial Summary

Adverse events are frequent in Neonatal Intensive Care Units' (NICU) patients and account for a high morbidity and mortality. Possible severe adverse events are central line associated bloodstream infections (CLABSI), ventilator and catheter associated adverse events and medication errors. Severity of the patient's outcome after an adverse event can be classified using the National Coordinating Council for Medication Error Reporting and Preventing (NCC MERP) Index for categorizing medication errors.

The study will test the hypothesis that rates of adverse events in NICU patients will be reduced by the implementation of an educational program for the NICU caregivers (nurses and physicians), consisting of strategies for recognizing and preventing adverse events in their unit. These strategies will be oriented to prevent CLABSI, medication errors, skin and nasal complications and ventilator and catheter-associated adverse events.

This trial has a stepped wedge cluster design, in which the NICUs from 12 hospitals in France will be randomized to the timing of implementation of the educational program.

In order to describe the adverse events occurring during the study period, an anonymous voluntary adverse event reporting system will be provided to the caregivers of the participating units. A nested study will examine how caregivers communicate with the patients' parents in case of adverse event (disclosure or not, and caregivers' reasons).

The rates of adverse events will be measured retrospectively using a neonatal NICU trigger tool.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Catheter-related Bloodstream Infection (CRBSI) Nos
• Extravasation Injury
• Healthcare-Associated Pneumonia
• Immature Newborn
• Intensive Care Units, Neonatal
• Intubation Complication
• IV Catheter Nos Deep Venous Thrombosis
• Medication Administered in Error
• Misadventures to Patients During Surgical and Medical Care
• Nasal Injury
• Nosocomial Pneumonia
• Pneumonia
• Quality of Healthcare
• Skin Lesion
• Thrombosis
• Venous Thrombosis
• Ventilator Adverse Event
• Wounds and Injuries

• NCT number: NCT02598609
• Study type: Interventional
• Source: Centre Hospitalier Intercommunal Creteil
• Status: Completed
• Phase: N/A
• Start date: November 23, 2015
• Completion date: December 8, 2020