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Effectiveness of the antiseptic barrier cap on rate of bloodstream infections


- candidate number24281
- NTR NumberNTR5833
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-apr-2016
- Secondary IDsMEC-2016-061 Erasmus MC-Sophia
- Public TitleEffectiveness of the antiseptic barrier cap on rate of bloodstream infections
- Scientific TitleEffectiveness of the antiseptic barrier cap on rate of bloodstream infections and central line associated bloodstream infections
- ACRONYMBarriercap
- hypothesisThe antiseptic barrier cap reduce the incidence of bloodstream infections and the rate of central line associated bloodstream infection (CLABSI) per 1.000 central line days among infants admitted on the neonatal intensive care unit and the paediatric intensive care unit.
- Healt Condition(s) or Problem(s) studiedSepsis, Critically ill children
- Inclusion criteriaAll infants admitted to the Neonatal Intensive Care Unit with peripheral catheter, tunneled and non-tunneled central venous catheters, and/or umbilical catheters.
Pediatric Intensive Care Unit all children with a tunneled and non-tunneled central venous catheters, and/or umbilical catheters and combined with a periferal catheter.
- Exclusion criteriaNA
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mei-2016
- planned closingdate1-mei-2017
- Target number of participants1700
- InterventionsAn antiseptic barrier cap will be investigated in a NICU and PICU setting, which is developed to improve disinfection procedures and helps to prevent bloodstream infections and CLABSIs by optimizing hub disinfection through cleaning of the catheter hub without active scrubbing.
- Primary outcomeRate of CLABSI per 1.000 central line days
- Secondary outcome- Compliance of the Healthcare workers who use the antiseptic barrier cap.
- Incidence of bloodstream infections
- Costs
- Timepointspreintervention: 24 months
intervention: 12 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Onno K. Helder
- CONTACT for SCIENTIFIC QUERIESDr. Onno K. Helder
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
None
- Publicationsplanned
- Brief summaryBloodstream infections and central line associated bloodstream infections (CLABSIs) are a commonly encountered complication in hospitalized infants and result in increased length of stay, cost, morbidity and mortality. Healthcare workers often do not apply an appropriate heb desinfection. The antiseptic barrier cap is developed to improve disinfection procedures. This observational study evaluate the incidence of bloodstream infections and the rate of central line associated bloodstream infections in infants and children addmitted to a neonatal and pediatric intensive care. Adherence to the barrier protocol will be measured.
- Main changes (audit trail)
- RECORD20-apr-2016 - 22-jun-2016


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