Reducing the prescription of antibiotics in newborn infants, suspected for an early onset sepsis.
Recruiting
- Conditions
- Early onset sepsisNeonatal sepsisCytokinesAntibioticsVroege infectieNeonatale infectieCytokinenAntibiotica
- Registration Number
- NL-OMON22612
- Lead Sponsor
- o sponsor
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 900
Inclusion Criteria
1. A newborn infant who is admitted to a pediatric or to a maternity ward and in whom an EOS cannot be excluded.
2. Informed consent of the parent or legal guardian.
Exclusion Criteria
1. Newborn infant older than 6 hours.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method proven EOS vs. no EOS<br /><br><br /><br><br><br>EOS is defined as a positive blood culture taken within 48 hours after birth. Cultures positive for organisms considered as contaminants (such as corynebacterium) are excluded.
- Secondary Outcome Measures
Name Time Method Secondary outcome: <br /><br>1. Proven EOS, <br /><br><br>2. Clinical EOS, <br /><br><br>3. Suspected EOS but afterwards no EOS, <br /><br>4. No EOS and never suspected for an EOS.