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

Recruiting now

Conditions studied: Ultrasound, Transcutaneous EMG, Diaphragm, Neonate

In brief

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.

Key facts

Study ID

NCT05965830

Run by

Leiden University Medical Center

People needed

50

Starts

2023-11-25

Expected to finish

2025-11-01

Last updated by the study team

2025-03-18

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 0 - 12 months of age at the moment of inclusion and born ≥ 37 weeks gestational age.
• Specific patients cohort PICU:
• pediatric patients with invasive respiratory support comply with the extubation readiness test (ERT) criteria
• No spontaneous breathing for the duration of the assessment
• Written parenteral informed consent (IC)
• A patient can only participate once

You may not qualify if…

• Unilateral diaphragm paresis diagnosed by ultrasound
• Congenital malformations not compatible with dEMG
• Need of cardiac pacing
• Congenital muscle atrophy disorder
• Clinical instability requiring frequent interventions by the nursing staff that may interfere with the measurements
• The attending physician considers the patient to be too vulnerable to participate in the study

Where it is running

• Pediatric Intensive Care Unit — Leiden, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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