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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48881

Enrollment

Registered

2018-06-08

Start date

2018-07-27

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Pulmonary transition respiratory distress

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

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

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Major congenital anomaly that prevents placement of EMG electrodes - Patients for whom life support will be witheld or withdrawn at birth will not be included

Design outcomes

Primary

Measure	Time frame
The feasibility of dEMG - recording in the delivery room (Signal quality of dEMG) during pulmonary transition expressed as the accuracy in heart rate and respiratory rate.	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results