Safely Reduce Newborn Antibiotic Exposure With the Early-onset Sepsis Calculator: a Cluster Randomized Study (EOS Calculator RCT)

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 1 day
Healthy Volunteers: f
View:

• 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;

• parental/guardian consent.

Locations
Other Locations
Netherlands
Northwest Clinics
RECRUITING
Alkmaar
FlevoHospital
RECRUITING
Almere Stad
Amstelland Hospital
RECRUITING
Amstelveen
OLVG
RECRUITING
Amsterdam
Martini Hospital
RECRUITING
Groningen
Spaarne Hospital
RECRUITING
Haarlem
Dijklander Hospital
RECRUITING
Hoorn
Canisius-Wilhelmina Hospital
RECRUITING
Nijmegen
Máxima Medical Center
RECRUITING
Veldhoven
Zaans Medical Centre
RECRUITING
Zaandam
Contact Information
Primary
Prof. Frans B. Plötz, MD, PhD
fbplotz@tergooi.nl
+31(0)887531753
Backup
Bo M. van der Weijden, MD
b.m.vanderweijden@amsterdamumc.nl
Time Frame
Start Date: 2022-04-12
Estimated Completion Date: 2024-10
Participants
Target number of participants: 1830
Treatments
No_intervention: NVK Guidelines
The NVK guidelines use 8 maternal and 15 neonatal risk factors, each categorized as either red flag or non-red flag. These criteria guide clinicians on the management in case of suspected EOS. Briefly, antibiotic treatment is recommended if at least one red flag and, or, two or more non-red flags are present. An observation period of at least 12 hours is recommended if one non-red flag is present. Antibiotics are recommended when an infection is suspected during this observation. Newborns without EOS risk factors, with a good clinical condition, and a gestational age of more than 36 weeks will be discharged. If the guidelines recommend an observation period, the newborn with a good clinical condition is discharged after repeating physical examination. In case antibiotic treatment is started, discharge depends on the duration of treatment and the clinical course. At discharge, parents are instructed to call the hospital in case of signs of infection within the first 14 days of life.
Experimental: EOS Calculator
Using the EOS calculator application between 0-24 hours after birth, maternal EOS risk factors combined with the physical examination of the newborn are used to assign a risk category and accompanying clinical recommendation based on estimated EOS incidence for each newborn at-risk for an infection. The EOS calculator results are used to guide clinical management on performing either a diagnostic work-up and start of antibiotics for (suspected) EOS, or a conservative approach with routine controls of vital parameters every 3 hours. In case of routine controls, re-evaluation of physical appearance by a pediatric resident or pediatrician will take place within 24 hours postpartum. Newborns will be observed for at least 24 hours. In case antibiotics are started, the need for further treatment is depending on blood culture results, infection parameters, and clinical condition of the newborn. Discontinuation of antibiotics and discharge is at the discretion of the treating physician.
Related Therapeutic Areas
Sponsors
Collaborators: Dutch Society of Pediatrics, Care4Neo, Zorgevaluatie Nederland, everywhereIM
Leads: prof. dr. Frans B. Plötz

This content was sourced from clinicaltrials.gov