Presepsin to safely reduce antibiotics in preterm infants (PRESAFE trial): a randomized controlled trial with concurrent observational cohort

• Conditions: blood stream infection; early-onset sepsis; 10004018

• Registration Number: NL-OMON56856
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 1266

Inclusion Criteria

Infants born between 24 and 31+6 weeks gestation are eligible for enrollment.
Infants at high- or low-risk of early-onset sepsis will be excluded for
randomization and included in the observational part of the study. Infants with
moderate risk for EOS are randomized 1:1.

Exclusion Criteria

Infants at low-risk or high-risk for EOS are not eligible for enrollment in the
randomization part of the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified