To decrease the incidence of sepsis after removal of central venous catheters in the neonatal intensive care unit.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
All neonates are followed for at least 72 hours after removal of the central
venous catheter to study the occurrence of clinical signs of infection and
follow laboratory parameters indicative of infection (C-reactive protein,
procalcitonin, blood leukocytes count).
Secondary outcome
na
Background summary
Retrospective study among neonates with a central-venous catheter showed taht
sepsis occurred frequently within 72 hours after removal of the catheter and
that sepsis was reduced in the group of infants who received antibiotics at the
moment of removal of the catheter. Therefore, a prospective study is suggested
on the protective effect of the administration of antibiotics on the incidence
of sepsis following a strict protocol.
Study objective
To decrease the incidence of sepsis after removal of central venous catheters
in the neonatal intensive care unit.
Study design
During the period of 1 year all neonates with a central venous catheter are
randomized to either receive antibiotics at removal of the catheter or not
receive antibiotics. The choice of antibiotics is based on the most frequently
isolated microorganisms that cause neonatal late-onset sepsis,
coagulase-negative staphylococci. These microorganisms are usually susceptible
for cefazolin. In case of increased risk for resistance, vancomycin is
administered.
Clinical data of all patients and data on the central venous catheters (type,
insertion site, age at insertion, duration) are collected prospectively.
Furthermore, data on antibiotic use are collected, the reason for the
administration af antibiotics and clinical signs of infection when they occur
and the results of the blood culture in case of sepsis. A blood culture
yielding coagulase-negative staphylococci is considered positive when the
culture became positive within 48 h.
Intervention
Neonates are randomized to either a group that receives antibiotics at the
moment of removal of the catheter or to a group that does not receive
antibiotics.
Study burden and risks
na
Postbus 85090
3508 AB Utrecht
Nederland
Postbus 85090
3508 AB Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Insertion of central venous catheter
Exclusion criteria
None
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL17110.041.07 |