Central venous catheter-related sepsis in premature neonates MedDRA version: 18.0 Level: LLT Classification code 10053212 Term: Catheter sepsis System Organ Class: 100000004862
Conditions
Interventions
Product Name: chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: chlorhexidine gluconate 2% w/v
Other descriptive name: 1,6-bis
Propan-2-ol
Concentration unit: % (V/V) percent volume/volume
Concentration type: equal
Concentration number: 70-
Product Name: chlorhexidine gluconate 2% w/v aqueous solution
Pharmaceutical Form: Cu
Sponsors
Norfolk and Norwich University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Preterm infants born at =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • No realistic prospect of survival in the short term • Life-threatening congenital abnormality • Already has another indwelling PCVC in situ or was previously enrolled into the study in respect of an earlier PCVC episode • Positive blood culture within the past 7 days without a subsequent negative BC result • Antibiotic treatment commenced for suspected sepsis within the preceding 48 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a small feasibility study of a group of babies whose skin will get cleaned with either aqueous- or alcohol-based formulations of 2% chlorhexidine antiseptic at the time of percutaneous central venous catheter (PCVC) insertion. Both the active ingredients in these antiseptics are presently very widely used, either alone or in combination, for skin disinfection in neonates in the UK, Europe, and North America. The primary objective is to obtain an estimate of what proportion of babies treated with the alcoholic version (2% chlorhexidine in 70% isopropyl alcohol) have PCVCs that are colonised with bacteria at the time that their catheters are removed. This will directly inform the sample size calculation for a future large-scale trial. ;Secondary Objective: The secondary objectives are: I. To gauge parents' and clinicians' willingness for babies to be randomised to 2%CHG or 70%IPA/2%CHG skin antisepsis and to determine views on factors that may affect recruitment II. To determine whether taking a skin swab after skin disinfection at catheter removal needs to be incorporated into the future large-scale trial. III. To examine whether culture of paired rather than single segments of removed catheters should be incorporated into the future large-scale trial, to increase the sensitivity of detection of catheter colonisation. IV. To determine whether molecular typing of skin and catheter isolates to a species level will be essential for the future large-scale trial. V. To estimate numbers of enrolled infants who have definite catheter-related sepsis VI. To estimate numbers of enrolled infants who have catheter-associated sepsis VII. To determine suitability and completeness of data collection methods. VIII. To describe any skin m;Primary end point(s): Proportion of babies in the 70%IPA/2%CHG arm with catheter colonisation as determined by positive bacterial culture from one or both of the catheter segments taken at catheter removal.;Timepoint( | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy measures: I. Rates of recruitment and retention to the study, and the collection of views of parents and clinicians on factors affecting recruitment and retention. II. Proportion of infants with positive exit-site skin swabs (ESSS) at catheter removal III. Number and type of catheter segments culture positive at removal IV. Bacterial species (typed via molecular methods) of isolates identified on positive BC, ESSS, and catheter segment V. Proportion of infants undergoing an infection screen in the period between catheter insertion and 48 hours post catheter removal who meet case definition for definite catheter-related sepsis VI. Proportion of infants with positive blood culture from any infection screen in the period between catheter insertion and 48 hours post catheter removal who meet definition for catheter-associated sepsis VII. Proportion of infants completing study with complete data for the primary outcome and proportions of infants with missing data collection forms Safety measure: VIII. Daily skin morbidity scores in the period between catheter insertion and 48 hours post catheter removal. ;Timepoint(s) of evaluation of this end point: All secondary outcome measures will be evaluated in full at the End of study | — |
Countries
United Kingdom
Contacts
Public ContactR+D Office
Norfolk and Norwich University Hospitals NHS Trust
Outcome results
None listed