Wireless unobtrusive cardiorespiratory monitoring directly after birth

Recruiting

• Conditions: neonatale monitoring; Fetal to neonatal transition; neonatal physiology

• Registration Number: NL-OMON53787
• Lead Sponsor: Jeroen Bosch Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 60

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

• 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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>time to display HR after belt application. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>ease of belt application, continuity and reliability of the monitor data<br /><br>throughout the monitored period, and workflow and parent-infant interaction in<br /><br>relation to the device throughout the monitored period as based on a limited<br /><br>number of questions. </p><br>