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SEPREVEN: a Stepped-wedge Randomised Controlled Trial (SEPREVEN)

Primary Purpose

Intensive Care Units, Neonatal, Misadventures to Patients During Surgical and Medical Care, Catheter-related Bloodstream Infection (CRBSI) Nos

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Education program for NICU caregivers
Sponsored by
Dr Caeymaex Laurence
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intensive Care Units, Neonatal focused on measuring Adverse event, Neonatal Intensive Care Unit, Catheter-related Bloodstream Infection (CRBSI) nos, Extravasation injury, Medication error, Central venous catheter complication, Unprogrammed extubation

Eligibility Criteria

1 Day - 20 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria :

  • Patients hospitalized during the study period in one of the 12 participating Neonatal Intensive Care Units
  • Corrected Gestational age not exceeding 42 weeks +6 days at the time of admission in the NICU
  • Length of hospitalisation in the NICU > 2 days
  • No parental objection to the anonymous data collection of their newborn(s)' clinical data, after written information

Exclusion Criteria:

  • More than 42 weeks +6 days of corrected gestational age on admission in the NICU
  • Length of hospitalization in the NICU < or = 2 days
  • Parental objection to the anonymous data collection of their newborn(s)' clinical data

Sites / Locations

  • CHU Strasbourg Hautepierre
  • CHU Grenoble
  • CHU Lille Jeanne de Flandres
  • CHI Creteil
  • CHU BicΓͺtre, APHP
  • CHU Robert DebrΓ©, APHP
  • CH Poissy
  • CH Pontoise RenΓ© Dubos
  • Centre Hospitalier Delafontaine
  • CHU Caen
  • CHU Angers
  • CHU Nice Archet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Cluster A

Cluster B

Cluster C

Arm Description

Out of the 12 participating NICUs, 4 NICUs are randomly assigned in Cluster A. The intervention (educational program for preventing adverse events and medical errors in the NICU) is implemented after a pre interventional period of 4 months. The intervention is implemented during 4 months. The length of the post interventional period is 12 months.

Out of the 12 participating NICUs, 4 NICUs are randomly assigned in Cluster B. The intervention (educational program for preventing adverse events and medical errors in the NICU) is implemented after a pre interventional period of 8 months. The intervention is implemented during 4 months. The length of the post interventional period is 8 months.

Out of the 12 participating NICUs, 4 NICUs are randomly assigned in Cluster C. The intervention (educational program for preventing adverse events and medical errors in the NICU) is implemented after a pre interventional period of 12 months. The intervention is implemented during 4 months. The length of the post interventional period is 4 months.

Outcomes

Primary Outcome Measures

Rates of adverse events (total number/1000 patient-days)
Assessment of the effectiveness of the program on reducing the rates of adverse events (number of adverse events/1000 patient-days) (AEs) measured using a retrospective chart review with a NICU trigger tool (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340). Out of the pool of patients included in the study, 3600 charts (60 charts per 4 months and per unit) will be randomly assigned to be reviewed using the NICU trigger tool. An adverse event is defined here as an injury, large or small, caused by the use (including non-use) of a drug, test, or medical treatment.(Trigger tool kit, Raju Ped Research). Preventable adverse events and non preventable adverse events secondary to expected complications or side effects are both included.

Secondary Outcome Measures

Rate of adverse events (Percentage of patient admissions with an adverse event) over time during the study period
Assessment of the effectiveness of the program on reducing the rate of adverse events (percentage of patient admissions with an adverse event) measured using a retrospective chart review with a NICU trigger tool (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340), over time during the inclusion period
Rate of adverse events (number of adverse events per 100 NICU admissions) over time during the study period
Assessment of the effectiveness of the program on reducing the rates of adverse events (number of adverse events per 100 admissions) (AEs) measured using a retrospective chart review with a NICU trigger tool (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340) over time
Rates of preventable adverse events (total number/1000 patient-days)
Assessment of the effectiveness of the program on reducing the rates of preventable adverse events (number of adverse events/1000 patient-days) (AEs) measured using a retrospective chart review with a NICU trigger tool (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340). Out of the pool of patients included in the study, 3600 charts (60 charts per 4 months and per unit) will be randomly assigned to be reviewed using the NICU trigger tool. An adverse event is defined here as an injury, large or small, caused by the use (including non-use) of a drug, test, or medical treatment. (see Trigger tool kit definitions and Raju Ped Research) Preventability is assessed according to the existence of an "error". Expected complications or side effects from therapeutic or diagnostic interventions are generally non-preventable, and hence are considered complications. (see Raju, Pediatric Research) Healthcare associated infections are considered preventable adverse events.
Rates of CLABSI, number per 1000 catheter-days in the 12 participating NICUs in France
Assessment of the effectiveness of the program on reducing the rates of Central line associated blood stream infections defined using the Primary Blood Stream Infections and LCBSI criteria (CDC/NHSN Device-Associated Module BSI January 2015), collected prospectively in the 12 participating NICUs. Analysis will include subgroups according to patient's characteristics and contextual factors (nurse staffing, unit occupancy, type of unit).
Rates of unplanned extubations, number per 100 ventilator-days and number per 100 ventilator-hours in the 12 participating NICUs in France.
Assessment of the effectiveness of the program on reducing the rates of adverse events caused/lead by unplanned extubations measured using the retrospective trigger tool chart review (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340). Out of the pool of patients included in the study, 3600 charts (60 charts per 4 months and per unit) will be randomly assigned to be reviewed using the NICU trigger tool.
Identify factors associated with and consequences of Unprogrammed extubation in NICU patients
Unprogrammed extubation: description of prospectively reported factors associated with UE (context and cause), and patients' characteristics, as well as HCP's assessment of preventability of this UE (multiple choices questionnaire) in the participating units. Prospective collection of outcome 30 minutes and 24 hours after UE (reintubation/ non invasive ventilation or spontaneous breathing and outcome severity grading) according to reported causal factors and patients' characteristics
Rates of severe adverse events
Assessment of the effectiveness of the program on reducing the rates of severe adverse events collected using a multisource prospective voluntary anonymous collection. Results will include control charts, and include patients' characteristics and contextual factors over time.
Describe rates of medication errors in NICU patients
Assessment of the effectiveness of the program on reducing the rates of adverse events related to medication errors, measured using the retrospective trigger tool chart review (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340). Out of the pool of patients included in the study, 3600 charts (60 charts per 4 months and per unit) will be randomly assigned to be reviewed using the NICU trigger tool; A medication error is defined here as any preventable event that causes or leads to inappropriate medication use with patient harm while the medication is in the control of the health care professional in the NICU. (see Raju Ped Research).
Identify factors associated with and consequences of medication errors in NICU patients
Type of medication, of error and consequences and patients' and unit's characteristics are collected prospectively in the participating NICUs
Identify factors associated with and consequences of catheter-related adverse in the NICU
Type of adverse event, consequence and patients' and unit's characteristics are collected prospectively in the participating NICUs
Rates of catheter-related adverse events, number per 1000 catheter-days
Assessment of the effectiveness of the program on reducing the rates of catheter-related adverse events collected prospectively and using the retrospective trigger tool chart review (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340) in the 12 participating NICUs
Identify number and types of medical errors collected in the 12 NICUs in France
Number and types of medical errors are defined as catheter related (central line), medication, ventilation, skin lesions, nasal injury, extravasation, enteral feeding, temperature control, unprogrammed extubation, surgical complications, diagnostic error or delay, parenteral fluid/nutrition adverse event, and, in existing, others. These "errors" are collected prospectively in each participating unit during the 20 months period, using a multi-source collection file (manual, anonymous and voluntary and/or institutional). A Medical Error is defined here as an error in health care, due to a failure of the planned action to be completed as intended, or using a wrong plan of action to achieve the goal, and excluding near misses. (see Raju Pediatric Research) Errors are included independently of the harm caused to the patient. Descriptions will include patients' characteristics and contextual factors.
Identify Severity of adverse events in the 12 participating NICUs in France
Identify Severity of adverse events, rated prospectively using the National Coordinating Council for Medication Error Reporting and Prevention Index for Categorizing Errors (NCC MERP, 2001)(including infectious and non infectious adverse events). Severity is described according to contextual factors and patients' characteristics.
Describe late-onset infections types and characteristics in NICU patients in France
Late-onset infections are defined according to the January 2015 CDC/NHSN Surveillance Definitions for all types of Specific Types of infections, for Primary Blood Stream Infections and for neonatal Ventilator associated pneumonia (Hospital-Acquired infections for neonates). Clinical sepsis without laboratory proven infection is included. Description includes type on infection, clinical and bacteriological characteristics and type of consequence - data are collected prospectively by physicians. Descriptions will be done including patients' characteristics and contextual factors.
Skin tolerance to cutaneous antisepsis : Dermatitis score results before and after an antisepsis procedure for umbilical and/or PICC catheter insertion in premature neonates born less than 32 weeks gestational age and aged less than 15 days.
Dermatitis scoring is based on the existing Dermatitis score used by Garland JS (Garland JS et al. J Perinatol 2009), traduced in french (Score sheet available on demand). Score ranges from 0 (no dermatitis) to 4, with severe dermatitis >= 2. Score is completed propectively by the nurse in care, before and untill 5 after the procedure. Scores wil be compared according to antiseptic procedure and patient's characteristics.
Description of Nasal scores results during the use of noninvasive nasal ventilation interfaces in neonates born less than 32 weeks of gestational age and aged less than 15 days
The nasal trauma score is based on the score used by Collins (Collins CL et al, Eur J Ped 2014). Score is completed prospectively by the nurse in care of the patient, in the first week of nasal ventilation (after extubation or not). Rates and type of nasal lesions according to interface and patient's characteristics will be described.
Identify characteristics ad factors associated with severe extravasation injuries in the 12 NICUs
Extravasation injuries from peripherally inserted short catheter score is rated from I to IV based on the classification described b are collected prospectively using the score described by Casanova (Casanova D et al, Br J Plastic Surgery 2001). Score is rated prospectively by nurse in care; for severe extravasation, context of extravasation (infused substances, site,...), patients' characteristics and consequences are collected prospectively.
Description of characteristics of disclosed and undisclosed adverse events to the patients' parents, caregivers' motivations, and perceived parental reactions
For each collected adverse event, caregivers self-administered written questionnaire assessing of adverse event has been told to parent(s), heath care professional's reasons to disclosure it or not, and in case of disclosure, parental reactions according to health care professional (multiple choices)
Economical impact of the program
Mortality (yes/no)
Economical impact of the program
NICU length of stay (days)
Economical impact of the program
Neurological complications (Intraventricular hemorrhage, leucomalacia) for prematures
Economical impact of the program
Hospitalization data: morbidity for prematures bronchopulmonary dysplasia at 36 weeks (yes/no); severe retinopathia (yes/no); severe enterocolitis (yes/no)
Rate of positive and negative blood cultures in NICU patients suspected of late onset infection according to volume of blood culture
Prospective record on volume of blood culture and results (positive/negative)
Description of safety culture in each of the 12 participating NICUs before and after patients' inclusion period
Safety culture is measured by a questionnaire filled in by the healthcare providers of the 12 units, in the weeks before the beginning and after the end of the patients' inclusion period using the french traduction of the Hospital Survey On Patient Safety Culture (HSOPSC)(http://www.ahrq.gov/qual/patientsafetyculture), named Questionnaire de mesure de la culture de sΓ©curitΓ© des soins en milieu hospitalier, validated by the CCECQA. A comparison of the results before and after the study will be described globally and per unit.

Full Information

First Posted
November 4, 2015
Last Updated
December 27, 2020
Sponsor
Dr Caeymaex Laurence
Collaborators
Paris 12 Val de Marne University, Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT02598609
Brief Title
SEPREVEN: a Stepped-wedge Randomised Controlled Trial
Acronym
SEPREVEN
Official Title
Study on Preventing Adverse Events in Neonates (SEPREVEN): a Stepped-wedge Randomised Controlled Trial to Reduce Adverse Event Rates in the NICU
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
November 23, 2015 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
December 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Caeymaex Laurence
Collaborators
Paris 12 Val de Marne University, Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Adverse event, Neonatal Intensive Care Unit, Catheter-related Bloodstream Infection (CRBSI) nos, Extravasation injury, Medication error, Central venous catheter complication, Unprogrammed extubation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
8000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cluster A
Arm Type
Other
Arm Description
Out of the 12 participating NICUs, 4 NICUs are randomly assigned in Cluster A. The intervention (educational program for preventing adverse events and medical errors in the NICU) is implemented after a pre interventional period of 4 months. The intervention is implemented during 4 months. The length of the post interventional period is 12 months.
Arm Title
Cluster B
Arm Type
Other
Arm Description
Out of the 12 participating NICUs, 4 NICUs are randomly assigned in Cluster B. The intervention (educational program for preventing adverse events and medical errors in the NICU) is implemented after a pre interventional period of 8 months. The intervention is implemented during 4 months. The length of the post interventional period is 8 months.
Arm Title
Cluster C
Arm Type
Other
Arm Description
Out of the 12 participating NICUs, 4 NICUs are randomly assigned in Cluster C. The intervention (educational program for preventing adverse events and medical errors in the NICU) is implemented after a pre interventional period of 12 months. The intervention is implemented during 4 months. The length of the post interventional period is 4 months.
Intervention Type
Behavioral
Intervention Name(s)
Education program for NICU caregivers
Intervention Description
standardized educational program : learning how to retrospectively analyze causes of a medical error in the NICU in order to prevent it (compulsory) implementation of a central line maintenance bundle and checklist, of a central line insertion bundle and checklist and of a daily goals bundle and checklist. (compulsory) poster for prevention of extravasation injuries
Primary Outcome Measure Information:
Title
Rates of adverse events (total number/1000 patient-days)
Description
Assessment of the effectiveness of the program on reducing the rates of adverse events (number of adverse events/1000 patient-days) (AEs) measured using a retrospective chart review with a NICU trigger tool (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340). Out of the pool of patients included in the study, 3600 charts (60 charts per 4 months and per unit) will be randomly assigned to be reviewed using the NICU trigger tool. An adverse event is defined here as an injury, large or small, caused by the use (including non-use) of a drug, test, or medical treatment.(Trigger tool kit, Raju Ped Research). Preventable adverse events and non preventable adverse events secondary to expected complications or side effects are both included.
Time Frame
20 months
Secondary Outcome Measure Information:
Title
Rate of adverse events (Percentage of patient admissions with an adverse event) over time during the study period
Description
Assessment of the effectiveness of the program on reducing the rate of adverse events (percentage of patient admissions with an adverse event) measured using a retrospective chart review with a NICU trigger tool (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340), over time during the inclusion period
Time Frame
20 months
Title
Rate of adverse events (number of adverse events per 100 NICU admissions) over time during the study period
Description
Assessment of the effectiveness of the program on reducing the rates of adverse events (number of adverse events per 100 admissions) (AEs) measured using a retrospective chart review with a NICU trigger tool (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340) over time
Time Frame
20 months
Title
Rates of preventable adverse events (total number/1000 patient-days)
Description
Assessment of the effectiveness of the program on reducing the rates of preventable adverse events (number of adverse events/1000 patient-days) (AEs) measured using a retrospective chart review with a NICU trigger tool (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340). Out of the pool of patients included in the study, 3600 charts (60 charts per 4 months and per unit) will be randomly assigned to be reviewed using the NICU trigger tool. An adverse event is defined here as an injury, large or small, caused by the use (including non-use) of a drug, test, or medical treatment. (see Trigger tool kit definitions and Raju Ped Research) Preventability is assessed according to the existence of an "error". Expected complications or side effects from therapeutic or diagnostic interventions are generally non-preventable, and hence are considered complications. (see Raju, Pediatric Research) Healthcare associated infections are considered preventable adverse events.
Time Frame
20 months
Title
Rates of CLABSI, number per 1000 catheter-days in the 12 participating NICUs in France
Description
Assessment of the effectiveness of the program on reducing the rates of Central line associated blood stream infections defined using the Primary Blood Stream Infections and LCBSI criteria (CDC/NHSN Device-Associated Module BSI January 2015), collected prospectively in the 12 participating NICUs. Analysis will include subgroups according to patient's characteristics and contextual factors (nurse staffing, unit occupancy, type of unit).
Time Frame
20 months
Title
Rates of unplanned extubations, number per 100 ventilator-days and number per 100 ventilator-hours in the 12 participating NICUs in France.
Description
Assessment of the effectiveness of the program on reducing the rates of adverse events caused/lead by unplanned extubations measured using the retrospective trigger tool chart review (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340). Out of the pool of patients included in the study, 3600 charts (60 charts per 4 months and per unit) will be randomly assigned to be reviewed using the NICU trigger tool.
Time Frame
20 months
Title
Identify factors associated with and consequences of Unprogrammed extubation in NICU patients
Description
Unprogrammed extubation: description of prospectively reported factors associated with UE (context and cause), and patients' characteristics, as well as HCP's assessment of preventability of this UE (multiple choices questionnaire) in the participating units. Prospective collection of outcome 30 minutes and 24 hours after UE (reintubation/ non invasive ventilation or spontaneous breathing and outcome severity grading) according to reported causal factors and patients' characteristics
Time Frame
20 months
Title
Rates of severe adverse events
Description
Assessment of the effectiveness of the program on reducing the rates of severe adverse events collected using a multisource prospective voluntary anonymous collection. Results will include control charts, and include patients' characteristics and contextual factors over time.
Time Frame
20 months
Title
Describe rates of medication errors in NICU patients
Description
Assessment of the effectiveness of the program on reducing the rates of adverse events related to medication errors, measured using the retrospective trigger tool chart review (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340). Out of the pool of patients included in the study, 3600 charts (60 charts per 4 months and per unit) will be randomly assigned to be reviewed using the NICU trigger tool; A medication error is defined here as any preventable event that causes or leads to inappropriate medication use with patient harm while the medication is in the control of the health care professional in the NICU. (see Raju Ped Research).
Time Frame
20 months
Title
Identify factors associated with and consequences of medication errors in NICU patients
Description
Type of medication, of error and consequences and patients' and unit's characteristics are collected prospectively in the participating NICUs
Time Frame
20 months
Title
Identify factors associated with and consequences of catheter-related adverse in the NICU
Description
Type of adverse event, consequence and patients' and unit's characteristics are collected prospectively in the participating NICUs
Time Frame
20 months
Title
Rates of catheter-related adverse events, number per 1000 catheter-days
Description
Assessment of the effectiveness of the program on reducing the rates of catheter-related adverse events collected prospectively and using the retrospective trigger tool chart review (Sharek PJ et al. Pediatrics 2006;118(4):1332-1340) in the 12 participating NICUs
Time Frame
20 months
Title
Identify number and types of medical errors collected in the 12 NICUs in France
Description
Number and types of medical errors are defined as catheter related (central line), medication, ventilation, skin lesions, nasal injury, extravasation, enteral feeding, temperature control, unprogrammed extubation, surgical complications, diagnostic error or delay, parenteral fluid/nutrition adverse event, and, in existing, others. These "errors" are collected prospectively in each participating unit during the 20 months period, using a multi-source collection file (manual, anonymous and voluntary and/or institutional). A Medical Error is defined here as an error in health care, due to a failure of the planned action to be completed as intended, or using a wrong plan of action to achieve the goal, and excluding near misses. (see Raju Pediatric Research) Errors are included independently of the harm caused to the patient. Descriptions will include patients' characteristics and contextual factors.
Time Frame
20 months
Title
Identify Severity of adverse events in the 12 participating NICUs in France
Description
Identify Severity of adverse events, rated prospectively using the National Coordinating Council for Medication Error Reporting and Prevention Index for Categorizing Errors (NCC MERP, 2001)(including infectious and non infectious adverse events). Severity is described according to contextual factors and patients' characteristics.
Time Frame
20 months
Title
Describe late-onset infections types and characteristics in NICU patients in France
Description
Late-onset infections are defined according to the January 2015 CDC/NHSN Surveillance Definitions for all types of Specific Types of infections, for Primary Blood Stream Infections and for neonatal Ventilator associated pneumonia (Hospital-Acquired infections for neonates). Clinical sepsis without laboratory proven infection is included. Description includes type on infection, clinical and bacteriological characteristics and type of consequence - data are collected prospectively by physicians. Descriptions will be done including patients' characteristics and contextual factors.
Time Frame
20 months
Title
Skin tolerance to cutaneous antisepsis : Dermatitis score results before and after an antisepsis procedure for umbilical and/or PICC catheter insertion in premature neonates born less than 32 weeks gestational age and aged less than 15 days.
Description
Dermatitis scoring is based on the existing Dermatitis score used by Garland JS (Garland JS et al. J Perinatol 2009), traduced in french (Score sheet available on demand). Score ranges from 0 (no dermatitis) to 4, with severe dermatitis >= 2. Score is completed propectively by the nurse in care, before and untill 5 after the procedure. Scores wil be compared according to antiseptic procedure and patient's characteristics.
Time Frame
20 months
Title
Description of Nasal scores results during the use of noninvasive nasal ventilation interfaces in neonates born less than 32 weeks of gestational age and aged less than 15 days
Description
The nasal trauma score is based on the score used by Collins (Collins CL et al, Eur J Ped 2014). Score is completed prospectively by the nurse in care of the patient, in the first week of nasal ventilation (after extubation or not). Rates and type of nasal lesions according to interface and patient's characteristics will be described.
Time Frame
20 months
Title
Identify characteristics ad factors associated with severe extravasation injuries in the 12 NICUs
Description
Extravasation injuries from peripherally inserted short catheter score is rated from I to IV based on the classification described b are collected prospectively using the score described by Casanova (Casanova D et al, Br J Plastic Surgery 2001). Score is rated prospectively by nurse in care; for severe extravasation, context of extravasation (infused substances, site,...), patients' characteristics and consequences are collected prospectively.
Time Frame
20 months
Title
Description of characteristics of disclosed and undisclosed adverse events to the patients' parents, caregivers' motivations, and perceived parental reactions
Description
For each collected adverse event, caregivers self-administered written questionnaire assessing of adverse event has been told to parent(s), heath care professional's reasons to disclosure it or not, and in case of disclosure, parental reactions according to health care professional (multiple choices)
Time Frame
20 months
Title
Economical impact of the program
Description
Mortality (yes/no)
Time Frame
20 months
Title
Economical impact of the program
Description
NICU length of stay (days)
Time Frame
20 months
Title
Economical impact of the program
Description
Neurological complications (Intraventricular hemorrhage, leucomalacia) for prematures
Time Frame
20 months
Title
Economical impact of the program
Description
Hospitalization data: morbidity for prematures bronchopulmonary dysplasia at 36 weeks (yes/no); severe retinopathia (yes/no); severe enterocolitis (yes/no)
Time Frame
20 months
Title
Rate of positive and negative blood cultures in NICU patients suspected of late onset infection according to volume of blood culture
Description
Prospective record on volume of blood culture and results (positive/negative)
Time Frame
20 months
Title
Description of safety culture in each of the 12 participating NICUs before and after patients' inclusion period
Description
Safety culture is measured by a questionnaire filled in by the healthcare providers of the 12 units, in the weeks before the beginning and after the end of the patients' inclusion period using the french traduction of the Hospital Survey On Patient Safety Culture (HSOPSC)(http://www.ahrq.gov/qual/patientsafetyculture), named Questionnaire de mesure de la culture de sΓ©curitΓ© des soins en milieu hospitalier, validated by the CCECQA. A comparison of the results before and after the study will be described globally and per unit.
Time Frame
20 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
20 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria : Patients hospitalized during the study period in one of the 12 participating Neonatal Intensive Care Units Corrected Gestational age not exceeding 42 weeks +6 days at the time of admission in the NICU Length of hospitalisation in the NICU > 2 days No parental objection to the anonymous data collection of their newborn(s)' clinical data, after written information Exclusion Criteria: More than 42 weeks +6 days of corrected gestational age on admission in the NICU Length of hospitalization in the NICU < or = 2 days Parental objection to the anonymous data collection of their newborn(s)' clinical data
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Caeymaex, MD, PhD
Organizational Affiliation
CHI Creteil, Paris Est University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Strasbourg Hautepierre
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67000
Country
France
Facility Name
CHU Grenoble
City
Grenoble
State/Province
Auvergne RhΓ΄ne Alpes
ZIP/Postal Code
38000
Country
France
Facility Name
CHU Lille Jeanne de Flandres
City
Lille
State/Province
Hauts De France
ZIP/Postal Code
59000
Country
France
Facility Name
CHI Creteil
City
Creteil
State/Province
Ile De France
ZIP/Postal Code
94000
Country
France
Facility Name
CHU BicΓͺtre, APHP
City
Le Kremlin BicΓͺtre
State/Province
Ile De France
ZIP/Postal Code
94270
Country
France
Facility Name
CHU Robert DebrΓ©, APHP
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75019
Country
France
Facility Name
CH Poissy
City
Poissy
State/Province
Ile De France
ZIP/Postal Code
78300
Country
France
Facility Name
CH Pontoise RenΓ© Dubos
City
Pontoise
State/Province
Ile De France
ZIP/Postal Code
95000
Country
France
Facility Name
Centre Hospitalier Delafontaine
City
St Denis
State/Province
Ile De France
ZIP/Postal Code
93210
Country
France
Facility Name
CHU Caen
City
Caen
State/Province
Normandie
ZIP/Postal Code
14000
Country
France
Facility Name
CHU Angers
City
Angers
State/Province
Pays De La Loire
ZIP/Postal Code
49000
Country
France
Facility Name
CHU Nice Archet
City
Nice
State/Province
Provence Alpes Cote d'Azur
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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SEPREVEN: a Stepped-wedge Randomised Controlled Trial

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