Skin Antiseptic Trial for Insertion of Central Venous Catheters in neonates

Phase 1

• Conditions: Central venous catheter-related sepsis in premature neonates; MedDRA version: 18.0Level: LLTClassification code 10053212Term: Catheter sepsisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-000874-36-GB
• Lead Sponsor: orfolk and Norwich University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-10
• Study Completion: 2019-10-15
• Last Update Posted: 2 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified