Evaluation of a non-invasive dynamic light scattering sensor for the measurement of heart rate in neonates.

Evaluation of a non-invasive dynamic light scattering sensor for the measurement of heart rate in neonates. - NEO-DLS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45284

Enrollment

Registered

2017-11-13

Start date

2017-08-27

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

prematuriteit premature birth Prematurity

Interventions

Dynamic light scattering

Electrocardiogram

Heart rate

Neonates

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Aged 26 weeks of gestation or older. Monitored by electrocardiogram in the Neonatal Intensive Care Unit of the Sophia Children*s Hospital. Written informed consent.

Exclusion criteria

Exclusion criteria: Absence of written informed consent A gestational age of

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the correlation of the detection of heart rate in beats per minute between ECG and the Elfi-Tech DLS sensor.	—

Secondary

Measure	Time frame
The correlation between flow measured with the Elfi-Tech DLS and Pulse Index (PI) from the pulse oximeter Peak detection and beat to beat analysis for the detection of measurement errors and signal disturbances. Determination of optimal measurement site. Assessment of measurement quality in patient groups with impaired peripheral perfusion; sepsis and therapeutic hypothermia. Heart rate variability measurements with ECG, pulse oximetry and the Elfi-Tech DLS sensor and their correlation.	—

Measure

Time frame

The correlation between flow measured with the Elfi-Tech DLS and Pulse Index (PI) from the pulse oximeter Peak detection and beat to beat analysis for the detection of measurement errors and signal disturbances. Determination of optimal measurement site. Assessment of measurement quality in patient groups with impaired peripheral perfusion; sepsis and therapeutic hypothermia. Heart rate variability measurements with ECG, pulse oximetry and the Elfi-Tech DLS sensor and their correlation.

—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)