Detection of neonatal sepsis with non-invasive transcutaneous blood gas monitoring

Recruiting

• Conditions: eonatal late-onset sepsis

• Registration Number: NL-OMON22567
• Lead Sponsor: Erasmus MC – Sophia Children’s Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

A gestational age of 24 weeks up to and including 31 weeks at the time of inclusion.
A pulse oximeter as part of regular care.
Written informed consent.

Exclusion Criteria

A gestational age of 32 weeks or more at the time of inclusion.
Skin condition contraindicating transcutaneous measurements.
Absence of written informed consent.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The relation between transcutaneous blood gas levels and neonatal sepsis.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the effect of patient age and time since birth on measurement accuracy.<br>The influence of ventilation and hemodynamic as measured by ventilation parameters, patient monitoring parameters, and registration of applied vasopressors on skin perfusion.<br>Correlation of sensor value deviations and drift from blood gas sample values between measured transcutaneous blood gas levels and heating power to analyze the effects of skin temperature and vascularization on measurement accuracy.<br>Assessment of the measurement quality and accuracy in patients with microcirculatory impairment.<br>Determine the effect of the sensor location on the level and reliability of the measurements.<br>Determine the relation between sepsis indicated by transcutaneous blood gas monitoring and questionnaires recording the clinical considerations for blood culturing by the attending neonatologist.