infection in newborns
Conditions
Interventions
The duration of antibiotic therapy in the standard group is based on the
attending physician*s assessment of the probability of infection during
hospitalisation: in group 1 and 2 patients, antibioti
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: Gestational age 34 weeks or more 3 or less days old Suspected infection requiring empiric antibiotic therapy Parental informed consent
Exclusion criteria
Exclusion criteria: Surgery during the first week of life Severe Malformations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the proportion of infants treated with antibiotics for > 48 - 72 hours (efficacy of study intervention). Co-primary endpoint is the absolute reduction of the duration of antibiotic therapy (quantitative version of the primary endpoint for estimation of effect size). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety endpoints: mortality, duration of hospitalization, recurrence of infection necessitating antibiotic therapy within the first month of life. | — |
Countries
Netherlands
Outcome results
None listed