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Clinical Trials/ISRCTN81931394
ISRCTN81931394
Completed
未知

An unblinded, two-arm randomised controlled trial to determine the effectiveness and cost-effectiveness of antimicrobial impregnated (with rifampicin and miconazole) long lines (termed peripherally inserted central venous catheters, or AM-PICC) compared with standard PICC (S-PICC) for reducing blood stream infection (BSI)

Great Ormond Street Hospital for Children NHS Foundation Trust (UK)0 sites861 target enrollmentNovember 21, 2014

Overview

Phase
未知
Intervention
Not specified
Conditions
Infectious disease, preterm babies requiring a PICC
Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust (UK)
Enrollment
861
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31040096 (added 02/05/2019)

Registry
who.int
Start Date
November 21, 2014
End Date
August 31, 2017
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Babies who require a PICC (Premicath 1 Fr)
  • 2\. Admitted to a NNU that is recruiting for this trial
  • 3\. Parent/legal representative of the baby gives informed written consent for the trial
  • Note: Babies with the following can be included in the trial:
  • 1\. Congenital malformations
  • 2\. Gastrointestinal surgical conditions
  • 3\. Previous PICC (non\-trial PICC)
  • 4\. Previously treated BSI which has resolved in the opinion of the Investigator

Exclusion Criteria

  • 1\. Baby has been previously entered into this trial
  • 2\. Baby has a known allergy or hypersensitivity to rifampicin or miconazole

Outcomes

Primary Outcomes

Not specified

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