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Wireless unobtrusive cardiorespiratory monitoring directly after birth

Wireless unobtrusive cardiorespiratory monitoring directly after birth - Cardiorespiratory monitoring directly after birth

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53787
Enrollment
60
Registered
2023-02-22
Start date
2023-03-15
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

neonatale monitoring Fetal to neonatal transition neonatal physiology

Interventions

None listed

Sponsors

Jeroen Bosch Ziekenhuis
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • The baby (at the moment of consent still a fetus) will be born in the Jeroen Bosch Hospital • Without (prenatal) indication for cardiorespiratory monitoring • With prenatal written informed consent from parents to participate in the study (in Dutch)

Exclusion criteria

Exclusion criteria: • Chest skin lesions at the site of the belt (the belt is intended for intact skin). • Congenital anomalies preventing placement of wearable belt, e.g. Siamese twins

Design outcomes

Primary

MeasureTime frame
time to display HR after belt application.

Secondary

MeasureTime frame
ease of belt application, continuity and reliability of the monitor data throughout the monitored period, and workflow and parent-infant interaction in relation to the device throughout the monitored period as based on a limited number of questions.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)