Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT06171867
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2023-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PNEUMACRIT Device for Neonatal Cardio Respiratory Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001261', 'term': 'Pulmonary Atelectasis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The device feasibility will be assessed in clinical environment with feedback from both the patient parents and nurses in NICU/PICU.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2023-11-23', 'studyFirstSubmitQcDate': '2023-12-06', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion (%) of recording time with high quality EIT-signal', 'timeFrame': '6-24 hours', 'description': 'Proportion of time that the collected EIT signal is accurate enough for reliable image reconstruction and observations of changes in lung aeration'}], 'secondaryOutcomes': [{'measure': 'Staff and parent questionnaires', 'timeFrame': '48 hours', 'description': 'After the study period, the patient parents and nurses will give feedback on the device and its feasibility with a structured questionnaire including also free text fields'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Electrical impedance tomography, neonate'], 'conditions': ['Neonatal Respiratory Distress']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.pneumacrit.com/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The usability of a new PNEUMACRIT system is studied in clinical environment in this feasibility study.', 'detailedDescription': 'Electrical impedance tomography is a noninvasive monitoring tool for neonatal lung aeration and breathing. This feasibility study will assess the usability of a new PNEUMACRIT electrode belt in clinical environment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '12 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatient at Oulu University Hospital PICU or NICU\n* Gestational age at birth over 32 weeks\n* Weight 2000-5000g\n* Postnatal age \\> 12 hours\n* Written informed consent from the parents of legal representative\n* Non-invasive monitoring of oxygen saturation and ECG\n\nExclusion Criteria:\n\n* Postmenstrual age \\< 32 weeks\n* Weight at time of the study \\< 2000g or \\> 5000g\n* Chest skin lesion preventing safe use of the electrode belt\n* Recent chest surgery within the past 7 days (e.g. thoracotomy)'}, 'identificationModule': {'nctId': 'NCT06171867', 'acronym': 'PNEUMACRIT', 'briefTitle': 'PNEUMACRIT Device for Neonatal Cardio Respiratory Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'Preterm Neonate/ Neonatal Embedded Universal Microelectronic Wearable Acquisition for Cardio Respiratory Intensive Therapy. Clinical Assessment of Device Usability and Reliability', 'orgStudyIdInfo': {'id': 'EETTMK: 73/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Feasibility of the PNEUMACRIT belt', 'description': 'Neonates will be monitored with a PNEUMACRIT electrode belt for 6 to 24 hours. After the study period, patient parents and nurses will give feedback.', 'interventionNames': ['Device: PNEUMACRIT']}], 'interventions': [{'name': 'PNEUMACRIT', 'type': 'DEVICE', 'description': 'Monitoring of breathing', 'armGroupLabels': ['Feasibility of the PNEUMACRIT belt']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oulu', 'country': 'Finland', 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oulu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Middlesex University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Principal investigator, Associate professor of pediatrics', 'investigatorFullName': 'Merja Kallio', 'investigatorAffiliation': 'University of Oulu'}}}}