Safely reduce newborn antibiotic exposure with the early-onset sepsis calculator: a cluster randomized study

Completed

Conditions: early-onset neonatal sepsis
neonatal sepsis
10004018

Registration Number: NL-OMON52299

Lead Sponsor: Tergooiziekenhuizen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1830

Inclusion Criteria

- postmenstrual age of 34 weeks or more;
- age between 0-24 hours;
- at least one EOS risk factor or clinical sign of infection (suspected of EOS)
present within the first 24 hours of life (see Table 1, chapter 3);
- parental consent.

Exclusion Criteria

- major congenital anomalies;
- language barrier (lack of effective communication or whenever it hinders
understanding).

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Co-primary superiority outcome<br /><br>The proportion of patients starting antibiotic therapy started for suspected<br /><br>and, or proven EOS in the first 24 hours after birth.<br /><br><br /><br>Co-primary non-inferiority outcome<br /><br>The presence of one or more of four predefined safety criteria, namely 1) the<br /><br>need for any respiratory support, and/or 2) the need for an intravascular fluid<br /><br>bolus for hemodynamic instability due to sepsis, and/or 3) referral to a<br /><br>Neonatal Intensive Care Unit for sepsis treatment, and/or 4) proven EOS. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are:<br /><br>- The total duration of antibiotic therapy;<br /><br>- The percentage antibiotic therapy started for suspected and, or proven EOS<br /><br>between 24 hours and 7 days after birth;<br /><br>- Quality of life: To get an impression of the impact of (suspected) EOS on<br /><br>parents/guardians and their child, parents/guardians will be asked to fill in a<br /><br>questionnaire on day 14.</p><br>