Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-28 @ 7:11 PM
Study NCT ID:
NCT02962505
Status:
COMPLETED
Last Update Posted:
2019-03-21
First Post:
2016-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Regional Analysis Device for Neonate Lung
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Greece']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001261', 'term': 'Pulmonary Atelectasis'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-19', 'studyFirstSubmitDate': '2016-11-03', 'studyFirstSubmitQcDate': '2016-11-08', 'lastUpdatePostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in aggregate measure of ventilation homogeneity (coefficient of variation and global inhomogeneity index of regional tidal volume) by > 10% compared with baseline', 'timeFrame': '72 hours'}, {'measure': 'Change in right-to-left and/or anteroposterior ventilation distribution by >10% compared with baseline', 'timeFrame': '72 hours'}, {'measure': 'Time and duration of right-to-left or left-to-right ventilation ratio >2:1', 'timeFrame': '72 hours'}, {'measure': 'Percentage of EIT examination time with at least 26 out of 32 sensors exhibiting skin contact impedance of < 700 Ohm', 'timeFrame': '72 hours', 'description': 'Skin contact impedance will be monitored continuously by the EIT device. If more than 6 sensors exhibit skin contact impedance \\> 700 Ohm, the examination is no longer suitable for analyzing. To assess the percentage of EIT measurements suitable for analyzing, we will calculate the percentage of EIT examination time with at least 26 out of 32 sensors exhibiting skin contact impedance of less than 700 Ohm.'}], 'secondaryOutcomes': [{'measure': 'Relationship between time of onset/end of non-invasive respiratory support and EIT findings', 'timeFrame': '72 hours'}, {'measure': 'Relationship between time of intubation/extubation and EIT findings', 'timeFrame': '72 hours'}, {'measure': 'Relationship between time of suctioning and EIT findings', 'timeFrame': '72 hours'}, {'measure': 'Relationship between time and type of posture change and EIT findings', 'timeFrame': '72 hours'}, {'measure': 'Relationship between time of surfactant administration and EIT findings', 'timeFrame': '72 hours'}, {'measure': 'Relationship between time of clinically indicated radiological examination and EIT findings', 'timeFrame': '72 hours'}, {'measure': 'Relationship between time of recruitment manoeuvre and EIT findings', 'timeFrame': '72 hours'}, {'measure': 'Relationship between time of confirmed pneumothorax and EIT findings', 'timeFrame': '72 hours'}, {'measure': 'Relationship between time of confirmed endotracheal tube malposition and EIT findings', 'timeFrame': '72 hours'}, {'measure': 'Relationship between primary cause of respiratory failure and EIT findings', 'timeFrame': '72 hours'}, {'measure': 'Relationship between fraction of inspired oxygen over time and EIT findings', 'timeFrame': '72 hours'}, {'measure': 'Relationship between saturation of peripheral oxygen over time and EIT findings', 'timeFrame': '72 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infant Respiratory Distress Syndrome', 'Acute Bronchiolitis', 'Acute Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '34898392', 'type': 'DERIVED', 'citation': 'Becher TH, Miedema M, Kallio M, Papadouri T, Karaoli C, Sophocleous L, Rahtu M, van Leuteren RW, Waldmann AD, Strodthoff C, Yerworth R, Dupre A, Benissa MR, Nordebo S, Khodadad D, Bayford R, Vliegenthart R, Rimensberger PC, van Kaam AH, Frerichs I. Prolonged Continuous Monitoring of Regional Lung Function in Infants with Respiratory Failure. Ann Am Thorac Soc. 2022 Jun;19(6):991-999. doi: 10.1513/AnnalsATS.202005-562OC.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess whether Electrical Impedance Tomography (EIT) has the potential to optimize the ventilator therapy, validate the effectiveness, efficacy and safety of nursing and medical interventions (endotracheal suctioning, posture changes, surfactant therapy, recruitment manoeuvres, etc.) and for early recognition of complications like pneumothorax and endotracheal tube misplacement. The study design is purely observational.', 'detailedDescription': 'EIT data will be recorded during 72 hours of routine clinical treatment. To prevent any decisions based on EIT information, the clinicians will be blinded to the EIT findings during the study period. Data on clinical interventions and clinical findings will be recorded using a specially adapted graphical user interface on the EIT device in combination with a paper-based case report form (CRF). EIT data analysis will be performed off-line.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study specifically focuses on the EIT monitoring of preterm and term neonates, small infants and children up to the age of 7 years treated in NICU and PICU as this is the population where the need for regional lung function monitoring tools is most urgently needed to optimize the ventilator therapy, validate the effectiveness, efficacy and safety of nursing and medical interventions (endotracheal suctioning, posture changes, surfactant therapy, alveolar recruitment, etc.) and prevent/minimize the occurrence of acute (pneumothorax, endotracheal tube misplacement) and chronic (chronic lung disease or bronchopulmonary dysplasia) adverse effects.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written, informed consent of both parents or legal representative\n* Admission in the NICU or PICU\n* Patients with or at high risk of developing respiratory failure needing respiratory support.\n\n o i.e. (oxygen need (FiO2\\>25%) AND noninvasive or invasive respiratory support) AND/OR repeated apnea with desaturations\n* Age from birth to 7 years o Initial focus will be on neonates up to 6 kg and 12 months age. Infants of higher weight up to 7 years age will be included as EIT belts for this age group become available.\n\nExclusion Criteria:\n\n* Post menstrual age less than 25 weeks\n* Body weight \\< 600 g\n* Electrically active implants\n* Thorax skin lesions\n* Prior participation for the same diagnosis of lung disease'}, 'identificationModule': {'nctId': 'NCT02962505', 'acronym': 'CRADL', 'briefTitle': 'Continuous Regional Analysis Device for Neonate Lung', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Schleswig-Holstein'}, 'officialTitle': 'Continuous Regional Analysis Device for Neonate Lung', 'orgStudyIdInfo': {'id': '668259'}}, 'contactsLocationsModule': {'locations': [{'city': 'Nicosia', 'country': 'Cyprus', 'facility': 'Archbishop Makarios III Hospital', 'geoPoint': {'lat': 35.17284, 'lon': 33.35397}}, {'city': 'Oulu', 'country': 'Finland', 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VU University Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Inez Frerichs, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Medical Center SH, Kiel , Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Schleswig-Holstein', 'class': 'OTHER'}, 'collaborators': [{'name': 'Middlesex University London', 'class': 'UNKNOWN'}, {'name': 'University College, London', 'class': 'OTHER'}, {'name': 'NICU of Makarios III Hospital-The Ministry of Health for the Republic of Cyprus', 'class': 'UNKNOWN'}, {'name': 'Bio-Medical Research Foundation', 'class': 'UNKNOWN'}, {'name': 'University of Geneva', 'class': 'UNKNOWN'}, {'name': 'Linneuniversitetet', 'class': 'UNKNOWN'}, {'name': 'SWISSTOM AG', 'class': 'UNKNOWN'}, {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, {'name': 'Studio Fifield', 'class': 'UNKNOWN'}, {'name': 'Panaxea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Inéz Frerichs', 'investigatorFullName': 'Inez Frerichs', 'investigatorAffiliation': 'University Hospital Schleswig-Holstein'}}}}