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

Launched by PROF. DR. FRANS B. PLÖTZ · Mar 9, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new tool called the Early-Onset Sepsis (EOS) calculator to see if it can help reduce the use of antibiotics in newborns who might have a serious infection called early-onset sepsis. Early-onset sepsis can happen within the first 72 hours after birth, and while only a small number of newborns actually have it, many are given antibiotics just in case. The trial is comparing the current guidelines for treating suspected EOS with the EOS calculator to determine if using the calculator can safely lower the number of newborns receiving antibiotics.

To participate in the trial, newborns must be at least 34 weeks old, be between 0 and 24 hours old, and show at least one sign that they might be at risk for an infection. Parents or guardians will need to give their consent for their baby to take part. If enrolled, families can expect to be part of a study that may help improve how newborns are treated for infections in the future, potentially leading to less unnecessary antibiotic use. It’s important to know that the trial is currently recruiting participants, and all eligible newborns, regardless of gender, can join.

Gender

ALL

Eligibility 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;
• • parental/guardian consent.
• Exclusion Criteria:
• • major congenital anomalies;
• • language barrier (lack of effective communication or whenever it hinders understanding).