NCT05965830 Comparing Electromyography of the Diaphragm With Ultrasound in Neonates and Children With Respiratory Support
| NCT ID | NCT05965830 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leiden University Medical Center |
| Condition | Ultrasound |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-11-25 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2023-11-25 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05965830 clinical trial?
This trial is open to participants of all sexes, aged 0 Months or older, up to 12 Months, studying Ultrasound. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05965830 currently recruiting?
Yes, NCT05965830 is actively recruiting participants. Contact the research team at s.g.j.heisterkamp@lumc.nl for enrollment information.
Where is the NCT05965830 trial being conducted?
This trial is being conducted at Leiden, Netherlands.
Who is sponsoring the NCT05965830 clinical trial?
NCT05965830 is sponsored by Leiden University Medical Center. The trial plans to enroll 50 participants.