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Skin antiseptic trial for insertion of central venous catheters in neonates

Not Applicable
Completed
Conditions
Specialty: Children, Primary sub-specialty: Neonatal
Infections and Infestations
Catheter infection
Registration Number
ISRCTN82571474
Lead Sponsor
orfolk and Norwich University Hospitals NHS Foundation Trust
Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30782955 protocol 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37907266/ (added 01/11/2023)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
116
Inclusion Criteria

1. Preterm infants born at <34 weeks’ gestation
2. Requiring routine insertion of a PCVC for parenteral nutrition
3. No new suspected sepsis with commencement of antibiotics occurring within the 48 hours preceding planned catheter insertion
4. No other indwelling PCVC already in situ

Exclusion Criteria

1. No realistic prospect of survival in the short term
2. Life-threatening congenital abnormality
3. Underlying skin condition
4. Already has another indwelling PCVC in situ or was previously enrolled into the study in respect of an earlier PCVC episode
5. Positive blood culture (BC) within the past 7 days without a subsequent negative blood culture result
6. Antibiotic treatment commenced for suspected sepsis within the preceding 48 hours

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Proportion of babies in the 70%IPA/2%CHG arm with catheter colonisation as determined by culture of catheter segments taken at the time of catheter removal.
Secondary Outcome Measures
NameTimeMethod
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