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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52299

Enrollment

1830

Registered

2022-01-14

Start date

2022-04-12

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

early-onset neonatal sepsis neonatal sepsis

Interventions

None listed

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Countries

Netherlands

Outcome results