Monitoring fetal-to-neonatal pulmonary transition after birth with transcutaneous electromyography of the diaphragm

Completed

• Conditions: Pulmonary transition; respiratory distress; 10028971

• Registration Number: NL-OMON48881
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

-Infants who are born,older than 26 weeks, and need monitoring of the pulmonary
transition
-Written parental informed consent acquired antenatal or deferred.

Exclusion Criteria

- Major congenital anomaly that prevents placement of EMG electrodes
- Patients for whom life support will be witheld or withdrawn at birth will not
be included

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>The feasibility of dEMG - recording in the delivery room (Signal quality of<br /><br>dEMG) during pulmonary transition expressed as the accuracy in heart rate and<br /><br>respiratory rate. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are:<br /><br>- Description of changes in electrical activity (peak, amplitude, tonic<br /><br>activity, etc.) of the diaphragm during the transition.<br /><br>- Comparison in timing of heart rate detection acquired by EMG, compared to CI<br /><br>and PO, in order to find out which method is the fastest in detecting heart rate<br /><br>- Besides heart rate monitoring and breathing monitoring, other parameters from<br /><br>the standard-of-care respiratory function monitor (RFM) are studied as well in<br /><br>order to investigate the effect of respiratory support on diaphragmatic<br /><br>activity.</p><br>