Improving respiratory monitoring by directly capturing the electrical activity of the diaphragm

Completed

• Conditions: Monitoring van ademhalingsfrequentie (en hartfrequentie) in neonaten; Cardio-respiratory status; premature infants

• Registration Number: NL-OMON49239
• Lead Sponsor: Jeroen Bosch Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-01-21
• Results First Posted: 2021-08-13
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

Gestational age 26 - 42 weeks
Written parental informed consent

Exclusion Criteria

-Patients requiring defibrillation. The device should be removed prior to start
of defibrillation -Patients with implanted electronic devices of any kind,
including cardiac pace-makers or similar assistive devices, electronic infusion
pumps and implanted stimulators
-Patients with irritated skin or open wounds or with allergies to Silver . In
case skin irritation or discomfort occurs, use of device must be discontinued.
-Patients requiring diagnostic imaging (X-thorax, MRI, cardiac ultrasonography)
during the study
-Unsuitability for an informed consent conversation; e.g. timewise or
attention-wise too much of a burden for parents
-Patients with parents who do not speak and/or read the native language or
English

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>To collect sufficient reference data of dEMG in neonates, in a representative<br /><br>population and for specific routine caregiving scenarios, to use for testing<br /><br>and optimizaton of the Bambi Belt B.V. algorithm. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>