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Clinical Trials/EUCTR2015-000874-36-GB
EUCTR2015-000874-36-GB
Active, not recruiting
Phase 1

The efficacy and safety of two topical antiseptic solutions for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: a feasibility study - Antiseptic Randomised Controlled Trial for Insertion of Catheters v1.0

orfolk and Norwich University Hospitals NHS Trust0 sites116 target enrollmentSeptember 10, 2015
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ConditionsCentral venous catheter-related sepsis in premature neonatesMedDRA version: 18.0Level: LLTClassification code 10053212Term: Catheter sepsisSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Central venous catheter-related sepsis in premature neonates
Sponsor
orfolk and Norwich University Hospitals NHS Trust
Enrollment
116
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 10, 2015
End Date
October 15, 2019
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
orfolk and Norwich University Hospitals NHS Trust

Eligibility Criteria

Inclusion Criteria

  • •Preterm infants born at \<34 weeks' gestation
  • •Requiring routine insertion of a PCVC for parenteral nutrition
  • •No new suspected sepsis with commencement of antibiotics occurring within the 48 hours preceding planned catheter insertion
  • •No other indwelling PCVC already in situ
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 93
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range 0
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range 0

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

Outcomes

Primary Outcomes

Not specified

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