Comparing diaphragm function measurement techniques in infants on respiratory support

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the relationship between transcutaneous diaphragm electromyography (dEMG) and diaphragm ultrasound (dUS) in infants and children under 12 months receiving invasive respiratory support in the Pediatric Intensive Care Unit (PICU). The study will involve simultaneous monitoring of diaphragm function using both techniques during extubation readiness tests. Clinically stable patients who meet specific inclusion criteria will be enrolled, and measurements will be taken to assess diaphragm muscle function. The goal is to establish a reliable method for evaluating diaphragm performance in this vulnerable population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

• Pediatric Intensive Care Unit
  Leiden, Netherlands Recruiting

Study contacts

• Study coordinator: Sabien Heisterkamp
• Email: s.g.j.heisterkamp@lumc.nl
• Phone: 003171529111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.