[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transcutaneous-emg\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transcutaneous-emg":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100513466","comparing-electromyography-of-the-diaphragm-with-ultrasound-in-neonates-and-children-with-respiratory-support-100513466",false,"NCT05965830","Comparing Electromyography of the Diaphragm With Ultrasound in Neonates and Children With Respiratory Support","PRospective Observational Study Comparing Electromyography of the Diaphragm With Ultrasound in Neonates and Children With REspiratory Support: the PROCEDURES Study","PROCEDURES","Inclusion Criteria:\n\n* Age between 0 - 12 months of age at the moment of inclusion and born ≥ 37 weeks gestational age.\n* Specific patients cohort PICU:\n\npediatric patients with invasive respiratory support comply with the extubation readiness test (ERT) criteria\n\n* No spontaneous breathing for the duration of the assessment\n* Written parenteral informed consent (IC)\n* A patient can only participate once\n\nExclusion Criteria:\n\n* Unilateral diaphragm paresis diagnosed by ultrasound\n* Congenital malformations not compatible with dEMG\n* Need of cardiac pacing\n* Congenital muscle atrophy disorder\n* Clinical instability requiring frequent interventions by the nursing staff that may interfere with the measurements\n* The attending physician considers the patient to be too vulnerable to participate in the study","ALL","0 Months","12 Months",{"count":21,"type":22},50,"ESTIMATED","1 Day","OBSERVATIONAL","Background of the study:\n\nIncreased 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\u002FPICU). 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).\n\nObjective of the study:\n\nOur objective is to assess the association between transcutaneous diaphragm electromyography (dEMG) and diaphragm ultrasound (dUS) in the PICU population.\n\nStudy design:\n\nSingle center pilot study\n\nStudy population:\n\nThe study population consists of children between 0-12 months, admitted to the PICU of the Leiden University Medical Center, with invasive respiratory support.\n\nPrimary study parameters\u002Foutcome of the study:\n\nPrimary endpoint is to evaluate the association between dEMG and dUS measurements in the PICU population.",[27,28,29,30],"Ultrasound","Transcutaneous EMG","Diaphragm","Neonate","RECRUITING","2025-03-17",{"date":34,"type":35},"2025-03-18","ACTUAL",{"date":37,"type":35},"2023-11-25",{"date":39,"type":22},"2025-11",{"name":41,"class":42},"Leiden University Medical Center","OTHER"]