SEPREVEN: a Stepped-wedge Randomised Controlled Trial
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | N/A - 20 Weeks |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT02598609 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Dr Caeymaex Laurence |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Laurence Caeymaex, MD, PhD |
Principal Investigator Affiliation | CHI Creteil, Paris Est University |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Active, not recruiting |
Countries | France |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Intensive Care Units, Neonatal, Misadventures to Patients During Surgical and Medical Care, Catheter-related Bloodstream Infection (CRBSI) Nos, Quality of Healthcare, Ventilator Adverse Event, Nosocomial Pneumonia, Immature Newborn, Skin Lesion, Extravasation Injury, Nasal Injury, Intubation Complication, Medication Administered in Error, IV Catheter Nos Deep Venous Thrombosis |
Contact a Trial Team
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