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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52386

Enrollment

Registered

2020-10-19

Start date

2021-10-14

Completion date

Unknown

Last updated

2025-09-01

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

Conditions

prematuriteit blood poisoning Sepsis

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: A gestational age of 24 weeks up to and including 31 weeks at the time of inclusion. A pulse oximeter. Written informed consent

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the relation between delta PO2 (PaO2 - tcPO2) and delta PCO2 (tcPCO2 - cPCO2) levels and sepsis.	—

Secondary

Measure	Time frame
Secondary study parameters include: - Evaluation of the effect of patient age and time since birth on measurement accuracy. - The influence of ventilation and hemodynamic as measured by ventilation parameters, patient monitoring parameters, and registration of applied vasopressors on skin perfusion by measuring delta PO2, delta PCO2, delta PI, and delta heating power levels over time. - Correlation of sensor value deviations and drift from blood gas sample values between measured tcPO2, tcPCO2 levels, cPCO2, and heating power to analyze the effects of skin temperature and vascularization on measurement accuracy. - Correlation between delta PO2, delta PCO2 levels, and delta heating power and Pulse Index (PI) from the pulse oximeter as an indicator of impaired perfusion. - Correlation between delta PO2, delta PCO2 levels, delta PI, and delta heating power to HeRO-score during impaired microcirculation. - Assessment of the measurement quality and accuracy in patients with microcirculatory impairment. - Correlation of delta PO2, delta PCO2, and delta heating power levels to changes in NIRS oxygen levels. - Correlating the delta PO2, delta PCO2, delta PI, and delta heating power to patient outcome. - Determine the effect of the sensor location on the level and reliability of the measurements. - Determine the relation between sepsis indicated by transcutaneous blood gas monitoring and questionnaires recording the clinical considerations for blood culturing by the attending neonatologist.	—

Measure

Time frame

Secondary study parameters include: - Evaluation of the effect of patient age and time since birth on measurement accuracy. - The influence of ventilation and hemodynamic as measured by ventilation parameters, patient monitoring parameters, and registration of applied vasopressors on skin perfusion by measuring delta PO2, delta PCO2, delta PI, and delta heating power levels over time. - Correlation of sensor value deviations and drift from blood gas sample values between measured tcPO2, tcPCO2 levels, cPCO2, and heating power to analyze the effects of skin temperature and vascularization on measurement accuracy. - Correlation between delta PO2, delta PCO2 levels, and delta heating power and Pulse Index (PI) from the pulse oximeter as an indicator of impaired perfusion. - Correlation between delta PO2, delta PCO2 levels, delta PI, and delta heating power to HeRO-score during impaired microcirculation. - Assessment of the measurement quality and accuracy in patients with microcirculatory impairment. - Correlation of delta PO2, delta PCO2, and delta heating power levels to changes in NIRS oxygen levels. - Correlating the delta PO2, delta PCO2, delta PI, and delta heating power to patient outcome. - Determine the effect of the sensor location on the level and reliability of the measurements. - Determine the relation between sepsis indicated by transcutaneous blood gas monitoring and questionnaires recording the clinical considerations for blood culturing by the attending neonatologist.

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Countries

Netherlands

Outcome results