Detection of neonatal sepsis using dynamic light scattering skin sensors

Detection of neonatal sepsis using dynamic light scattering skin sensors - Detection Of Neonatal Sepsis (DONS)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54452

Enrollment

Registered

2021-04-30

Start date

2022-05-13

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

neonatale sepsis blood poisoning sepsis

Interventions

None listed

Eligibility

Age

No minimum to 1 Years

Inclusion criteria

Inclusion criteria: - Suspicion of late-onset sepsis - Written informed consent of parents or guardian - Blood culture is drawn

Exclusion criteria

Exclusion criteria: - Skin disorder (including frailty of the skin) for which the skin adhesive is contraindicated

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the microcirculatory red blood cell velocity measured with the dynamic light scattering sensor in neonates during sepsis compared to neonates in whom sepsis is not proven.	—

Secondary

Measure	Time frame
Secondary study endpoints include: - Sensitivity and specificity of measured changes in the microcirculatory blood velocity and relative blood flow during neonatal sepsis between patients who develop sepsis and patients in whom sepsis is only suspected - The correlation between measured changes in the microcirculatory blood velocity and relative blood flow, and changes in central hemodynamic system during recovery from neonatal sepsis - The difference between centrally and peripherally measured blood velocity and relative blood flow. - The optimal location for determining changes in the microcirculatory blood velocity and relative blood flow during neonatal sepsis - The accuracy of the heart rate measured with dynamic light scattering - The calculation of the cardiac output from the pulsatile flow waveform - The relation between heart rate variability changes and changes in microcirculatory blood velocity and relative blood flow. - The effect of inotropic administration, or other clinical interventions, on microcirculatory blood velocity and relative blood flow. - Peak detection and beat-to-beat analysis for the detection of measurement errors and signal disturbances	—

Measure

Time frame

Secondary study endpoints include: - Sensitivity and specificity of measured changes in the microcirculatory blood velocity and relative blood flow during neonatal sepsis between patients who develop sepsis and patients in whom sepsis is only suspected - The correlation between measured changes in the microcirculatory blood velocity and relative blood flow, and changes in central hemodynamic system during recovery from neonatal sepsis - The difference between centrally and peripherally measured blood velocity and relative blood flow. - The optimal location for determining changes in the microcirculatory blood velocity and relative blood flow during neonatal sepsis - The accuracy of the heart rate measured with dynamic light scattering - The calculation of the cardiac output from the pulsatile flow waveform - The relation between heart rate variability changes and changes in microcirculatory blood velocity and relative blood flow. - The effect of inotropic administration, or other clinical interventions, on microcirculatory blood velocity and relative blood flow. - Peak detection and beat-to-beat analysis for the detection of measurement errors and signal disturbances

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Countries

Netherlands

Outcome results