Prevent Catheter Infections in Neonates. (Investigation on reducing the rate of bacterial colonization of central venous line in preterms by using a miconazole-rifampicin incorporated catheter.)
- Conditions
- P36.8Other bacterial sepsis of newborn
- Registration Number
- DRKS00005601
- Lead Sponsor
- Perinatalzentrum der LMU am Klinikum Großhadern
- Brief Summary
Results: The rate of colonization was lower in neonates who received an IP-PICC as compared to S-PICC (5.6% vs. 12.1% respectively; p = 0.42). However, the difference was not significant. In IP-PICC vs S-PICC, catheter related local infection (CRI) although lower was not statistically significant (2.9% vs. 6.1%; p = 0.60). We observed no difference in catheter related systemic infection (CR-SI) (0% vs. 3.1%, p = 0.48). The neonates whose catheters were colonized were predominantly of a lower gestational age (median 254/7, p = 0.05) and males (100%, p = 0.01). In addition, the median colony count in the colonized IP-PICC catheters was lower as compared to S- PICC group (53 vs 250, p = 0.06).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 83
preterm and term babies
Malformation syndromes, congenital heart defect, immunodeficiency, chromosomal aberration
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method This prospective study compares whether the incidence of bacterial colonization and catheter related infections can be reduced using a conventional respectively miconazole-rifampicin incorporated catheter. After using the catheter they are tested microbiologically. <br>Used Catheters with more than 15 colony-forming units are classified as colonized.<br>Number of Patients n=80.
- Secondary Outcome Measures
Name Time Method ocal/ systemic reactions:<br>flush<br>induration<br>thrombophlebitis<br>elevated CrP-levels<br>Leucopenia/ cytosis<br>catheter related:<br>perforation, obstruction