Reducing the prescription of antibiotics in newborn infants suspected for having an early onset sepsis.

Recruiting

Conditions: Early Onset Sepsis
10028920
Infection
10004018

Registration Number: NL-OMON31252

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 920

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.) A newborn infant who is admitted to a pediatric ward for glucose controls and who is not suspected for an EOS.

Exclusion Criteria

1a.) Newborn infant older than 6 hours.;2a.) Newborn infant older than 6 hours.
2b.) Newborn infant suspected for an EOS.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome: proven EOS<br /><br><br /><br>Primary parameters: cytokine levels direct post partum (umbilical cord and<br /><br>infant), 4 hours post partum, 24 hours post partum and 48 hours post partum.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary outcome: 1.) Proven EOS, 2.) Clinical EOS, 3.) Suspected EOS but<br /><br>afterwards no EOS and 4.) No EOS and never suspected for an EOS.<br /><br><br /><br>Secundary parameters:<br /><br>CRP<br /><br>Gestational age<br /><br>Birth weight<br /><br>Gender<br /><br>Number of previous pregnancies<br /><br>Parity<br /><br>Route of delivery<br /><br>Antibiotic usage mother ante partum<br /><br>Corticosteroid usage mother<br /><br>Duration of rupture of membranes<br /><br>Body temperature mother<br /><br>Temperature delivery room<br /><br>Epidural anesthesia mother<br /><br>CTG<br /><br>Umbilical cord pH<br /><br>Meconium aspiration<br /><br>Amnionitis<br /><br>Intracranial bleeding<br /><br>Respiratory problems<br /><br>Circulatory problems<br /><br>Neurological problems<br /><br>Gastro-intestinal problems<br /><br>Pathogen of Early Onset Sepsis<br /><br>Antibiotic prescription infants (duration & type)<br /><br>Outcome</p><br>