Safely Reduce Newborn Antibiotic Exposure With the Early-onset Sepsis Calculator

Summary

Newborns are at risk for early-onset sepsis (EOS), which occurs within 72 hours after birth. The incidence of proven EOS is 0.5-2.0 per 1000 live births. The annual birth rate in the Netherlands is around 170.000, consequently the number of EOS cases varies between 85 to 340. However, about 5%, thus 8500, of late preterm and term newborns receive empiric antibiotic therapy in compliance with the current Dutch guideline. An alternative is the CE certified EOS calculator application, which calculates an individual EOS risk with treatment advice. In this prospective cluster-randomized multicenter trial the current Dutch guideline will be compared with the EOS calculator in newborns at risk for EOS.

The primary objectives of this study are:

1. To investigate whether the use of the EOS calculator reduces antibiotic exposure in newborns with suspected EOS in the first 24 hours after birth.
2. To investigate the presence of one or more of the following 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 objectives of the study are:

1. To investigate if the use of the EOS calculator decreases the total duration of antibiotic therapy in newborns with suspected EOS.
2. To investigate if the use of the EOS calculator decreases the percentage of antibiotic therapy started for suspected and, or proven EOS if symptoms started between 24-72 hours after birth.
3. To study the impact of (suspected) EOS on parents/guardians.

Conditions

• Early-Onset Sepsis, Neonatal
• EOS

Interventions

DEVICE

EOS calculator

For this study the EOS calculator was developed as a mobile application (by everywhereIM), including CE marking. It is concerned a medical device for health care professionals.

Sponsors & Collaborators

• Dutch Society of Pediatrics

  collaborator UNKNOWN

• Zorgevaluatie Nederland

  collaborator UNKNOWN

• Care4Neo

  collaborator UNKNOWN

• everywhereIM

  collaborator UNKNOWN

• prof. dr. Frans B. Plötz

  lead OTHER

Principal Investigators

• Frans B. Plötz, MD, PhD · Amsterdam UMC, Tergooi Ziekenhuizen

• Niek B. Achten, MD, PhD · Erasmus Medical Center

• Bo M. van der Weijden, MD · Amsterdam UMC, Tergooi Ziekenhuizen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

24 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-12

Primary Completion

2024-04-30

Completion

2024-10-31

Countries

• Netherlands

Study Locations