AgION Catheter for Preventing Catheter-Related Bloodstream Infections
Reduction of Catheter-Related Bloodstream Infections in Preterm Infants by the Use of Catheters With the AgION Antimicrobial System
1 other identifier
interventional
86
1 country
1
Brief Summary
The investigators assessed if use of AgION-impregnated umbilical catheters can decrease the occurrence of catheter-related bloodstream infections (CRBSI) in preterm infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 19, 2012
CompletedFirst Posted
Study publicly available on registry
March 28, 2012
CompletedMarch 28, 2012
March 1, 2012
1.9 years
March 19, 2012
March 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of CRBSIs
We evaluated the incidence of CRBSIs (definite plus probable) during the time the UVC was in place.
Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
Secondary Outcomes (4)
Infection density
Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
Likelihood of freedom from CRIBSIs
Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
AgION catheters tolerability
Infants were followed for the duration the AgION umbilical venous catheter (UVC) was in place, an expected average of 10 days
Case fatality rate for infants with CRBSI
Hospital stay duration, an expected average of 80 days
Study Arms (2)
AgION catheter
EXPERIMENTALPatients in this arm received an AgION impregnated catheter (4.0-5.0 F Lifecath PICC ExpertTM, Vygon, Ecouen, France).
Non-impregnated polyurethane catheter
ACTIVE COMPARATORPatients in this arm received a non-impregnated polyurethane umbilical catheter (3.5-5.0 F ArgyleTM, Kendall, Tullamore, Iceland)
Interventions
Infants received a AgION impregnated catheter (4.0-5.0 F Lifecath PICC ExpertTM, Vygon, Ecouen, France).
Infants received a polyurethane non-impregnated catheter (3.5-5.0 F ArgyleTM, Kendall, Tullamore, Iceland)
Eligibility Criteria
You may qualify if:
- Gestational age \< 30 weeks
- Need of an umbilical venous catheter in the first week of life
- Parental informed consent.
You may not qualify if:
- Major congenital malformations
- Hydrops fetalis
- Inherited congenital metabolic diseases
- Death during the first week of life
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Careggi Univesity Hospital
Florence, Italy, 50141, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlo Dani, MD
Department of Surgical and Medical Critical Care, Section of Neonatology, University of Florence
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
March 19, 2012
First Posted
March 28, 2012
Study Start
July 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
March 28, 2012
Record last verified: 2012-03