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Comparing Electromyography of the Diaphragm With Ultrasound in Neonates and Children With Respiratory Support

NCT05965830 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-03-18

No results posted yet for this study

Summary

Background of the study:

Increased work of breathing, potentially leading to respiratory insufficiency, resulting in the need of (non-) invasive respiratory support is the most common observed problem in the neonatal - and pediatric intensive care unit (NICU/PICU). The diaphragm is the main respiratory muscle. Currently there is not an established technique accessible to observe the (clinical) function of the diaphragm and its role in respiratory insufficiency. New non-invasive modalities are promising, such as transcutaneous diaphragm electromyography (dEMG) and diaphragm ultrasound (dUS).

Objective of the study:

Our objective is to assess the association between transcutaneous diaphragm electromyography (dEMG) and diaphragm ultrasound (dUS) in the PICU population.

Study design:

Single center pilot study

Study population:

The study population consists of children between 0-12 months, admitted to the PICU of the Leiden University Medical Center, with invasive respiratory support.

Primary study parameters/outcome of the study:

Primary endpoint is to evaluate the association between dEMG and dUS measurements in the PICU population.

Conditions

  • Ultrasound
  • Transcutaneous EMG
  • Diaphragm
  • Neonate

Interventions

DEVICE

Diaphragm ultrasound

A single, simultaneous assessment of the diaphragm muscle functioning through dEMG and dUS at the time of spontaneous breathing.

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Eligibility

Min Age
0 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-25
Primary Completion
2025-10-31
Completion
2025-11-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05965830 on ClinicalTrials.gov