Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
8000 participants
INTERVENTIONAL
2015-11-23
2020-12-08
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Cluster A
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.
Education program for NICU caregivers
* 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
Cluster B
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.
Education program for NICU caregivers
* 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
Cluster C
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.
Education program for NICU caregivers
* 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
Interventions
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Education program for NICU caregivers
* 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
Eligibility Criteria
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Inclusion Criteria
* 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
* Length of hospitalization in the NICU \< or = 2 days
* Parental objection to the anonymous data collection of their newborn(s)' clinical data
1 Day
20 Weeks
ALL
No
Sponsors
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Paris 12 Val de Marne University
OTHER
Ministry of Health, France
OTHER_GOV
Dr Caeymaex Laurence
OTHER
Responsible Party
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Dr Caeymaex Laurence
Dr, PhD
Principal Investigators
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Laurence Caeymaex, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CHI Creteil, Paris Est University
Locations
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CHU Strasbourg Hautepierre
Strasbourg, Alsace, France
CHU Grenoble
Grenoble, Auvergne-Rhône-Alpes, France
CHU Lille Jeanne de Flandres
Lille, Hauts-de-France, France
CHU Caen
Caen, Normandy, France
CHU Angers
Angers, Pays de la Loire Region, France
CHU Nice Archet
Nice, Provence-Alpes-Côte d'Azur Region, France
CHI Creteil
Créteil, Île-de-France Region, France
CHU Bicêtre, APHP
Le Kremlin-Bicêtre, Île-de-France Region, France
CHU Robert Debré, APHP
Paris, Île-de-France Region, France
CH Poissy
Poissy, Île-de-France Region, France
CH Pontoise René Dubos
Pontoise, Île-de-France Region, France
Centre Hospitalier Delafontaine
Saint-Denis, Île-de-France Region, France
Countries
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References
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Sharek PJ, Horbar JD, Mason W, Bisarya H, Thurm CW, Suresh G, Gray JE, Edwards WH, Goldmann D, Classen D. Adverse events in the neonatal intensive care unit: development, testing, and findings of an NICU-focused trigger tool to identify harm in North American NICUs. Pediatrics. 2006 Oct;118(4):1332-40. doi: 10.1542/peds.2006-0565.
Sharek PJ. The Emergence of the Trigger Tool as the Premier Measurement Strategy for Patient Safety. AHRQ WebM&M. 2012 May 1;2012(5):120. No abstract available.
Chedoe I, Molendijk H, Hospes W, Van den Heuvel ER, Taxis K. The effect of a multifaceted educational intervention on medication preparation and administration errors in neonatal intensive care. Arch Dis Child Fetal Neonatal Ed. 2012 Nov;97(6):F449-55. doi: 10.1136/fetalneonatal-2011-300989. Epub 2012 Apr 5.
Dabliz R, Levine S. Medication safety in neonates. Am J Perinatol. 2012 Jan;29(1):49-56. doi: 10.1055/s-0031-1285831. Epub 2011 Aug 22.
Palmero D, Di Paolo ER, Beauport L, Pannatier A, Tolsa JF. A bundle with a preformatted medical order sheet and an introductory course to reduce prescription errors in neonates. Eur J Pediatr. 2016 Jan;175(1):113-9. doi: 10.1007/s00431-015-2607-4. Epub 2015 Aug 15.
Fisher D, Cochran KM, Provost LP, Patterson J, Bristol T, Metzguer K, Smith B, Testoni D, McCaffrey MJ. Reducing central line-associated bloodstream infections in North Carolina NICUs. Pediatrics. 2013 Dec;132(6):e1664-71. doi: 10.1542/peds.2013-2000. Epub 2013 Nov 18.
Smulders CA, van Gestel JP, Bos AP. Are central line bundles and ventilator bundles effective in critically ill neonates and children? Intensive Care Med. 2013 Aug;39(8):1352-8. doi: 10.1007/s00134-013-2927-7. Epub 2013 Apr 25.
Schulman J, Stricof R, Stevens TP, Horgan M, Gase K, Holzman IR, Koppel RI, Nafday S, Gibbs K, Angert R, Simmonds A, Furdon SA, Saiman L; New York State Regional Perinatal Care Centers. Statewide NICU central-line-associated bloodstream infection rates decline after bundles and checklists. Pediatrics. 2011 Mar;127(3):436-44. doi: 10.1542/peds.2010-2873. Epub 2011 Feb 21.
Casanova D, Bardot J, Magalon G. Emergency treatment of accidental infusion leakage in the newborn: report of 14 cases. Br J Plast Surg. 2001 Jul;54(5):396-9. doi: 10.1054/bjps.2001.3593.
Collins CL, Barfield C, Horne RS, Davis PG. A comparison of nasal trauma in preterm infants extubated to either heated humidified high-flow nasal cannulae or nasal continuous positive airway pressure. Eur J Pediatr. 2014 Feb;173(2):181-6. doi: 10.1007/s00431-013-2139-8. Epub 2013 Aug 18.
Farquhar C, Armstrong S, Kim B, Masson V, Sadler L. Under-reporting of maternal and perinatal adverse events in New Zealand. BMJ Open. 2015 Jul 23;5(7):e007970. doi: 10.1136/bmjopen-2015-007970.
Raju TN, Suresh G, Higgins RD. Patient safety in the context of neonatal intensive care: research and educational opportunities. Pediatr Res. 2011 Jul;70(1):109-15. doi: 10.1203/PDR.0b013e3182182853.
Garland JS, Alex CP, Uhing MR, Peterside IE, Rentz A, Harris MC. Pilot trial to compare tolerance of chlorhexidine gluconate to povidone-iodine antisepsis for central venous catheter placement in neonates. J Perinatol. 2009 Dec;29(12):808-13. doi: 10.1038/jp.2009.161. Epub 2009 Oct 8.
Yager H, Tauzin M, Durrmeyer X, Todorova D, Storme L, Debillon T, Casagrande F, Jung C, Audureau E, Layese R, Caeymaex L; SEPREVEN Study Group. Respiratory outcomes and survival after unplanned extubation in the NICU: a prospective cohort study from the SEPREVEN trial. Arch Dis Child Fetal Neonatal Ed. 2024 Oct 18;109(6):586-593. doi: 10.1136/archdischild-2023-326679.
Jaloustre M, Cohen R, Biran V, Decobert F, Layese R, Audureau E, Le Sache N, Chevallier M, Boukhris MR, Bolot P, Caeymaex L, Tauzin M; with the SEPREVEN study Group. Determinants of morbidity and mortality related to health care-associated primary bloodstream infections in neonatal intensive care units: a prospective cohort study from the SEPREVEN trial. Front Pediatr. 2023 May 31;11:1170863. doi: 10.3389/fped.2023.1170863. eCollection 2023.
Passini L, Le Bouedec S, Dassieu G, Reynaud A, Jung C, Keller ML, Lefebvre A, Katty T, Baleyte JM, Layese R, Audureau E, Caeymaex L; SEPREVEN Study Group. Error disclosure in neonatal intensive care: a multicentre, prospective, observational study. BMJ Qual Saf. 2023 Oct;32(10):589-599. doi: 10.1136/bmjqs-2022-015247. Epub 2023 Mar 14.
Caeymaex L, Astruc D, Biran V, Marcus L, Flamein F, Le Bouedec S, Guillois B, Remichi R, Harbi F, Durrmeyer X, Casagrande F, Le Sache N, Todorova D, Bilal A, Olivier D, Reynaud A, Jacquin C, Roze JC, Layese R, Danan C, Jung C, Decobert F, Audureau E. An educational programme in neonatal intensive care units (SEPREVEN): a stepped-wedge, cluster-randomised controlled trial. Lancet. 2022 Jan 22;399(10322):384-392. doi: 10.1016/S0140-6736(21)01899-7.
Caeymaex L, Lebeaux C, Roze JC, Danan C, Reynaud A, Jung C, Audureau E. Study on preventing adverse events in neonates (SEPREVEN): A stepped-wedge randomised controlled trial to reduce adverse event rates in the NICU. Medicine (Baltimore). 2020 Jul 31;99(31):e20912. doi: 10.1097/MD.0000000000020912.
Other Identifiers
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SEPREVEN
Identifier Type: -
Identifier Source: org_study_id