Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT06372951
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2023-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lung Ultrasound in Neonatal Intensive Care Units
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2023-11-29', 'studyFirstSubmitQcDate': '2024-04-16', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identifying causes of neonatal respiratory distress', 'timeFrame': 'Baseline', 'description': '\\- To evaluate lung ultrasound accuracy and reliability in diagnosing pulmonary disease in neonates in comparison to x rays'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neonatal Respiratory Distress']}, 'descriptionModule': {'briefSummary': 'Identification of lung diseases causing neonatal respiratory distress by lung ultrasound as a tool that can replace x-ray .', 'detailedDescription': '* Lung disease is the most common cause of neonatal respiratory distress.\n* It can result in respiratory failure and death in severe cases.\n* The mortality rate is approximately 11%:32%.\n* Identification of the etiology of lung disease is important for neonatologists.\n* Traditionally, chest X-ray has been considered as the most valuable imaging modality for the diagnosis of lung diseases, but it unavoidably causes radiation damage to the patient.\n* Neonates are susceptible to radiation because they have rapidly dividing cells that cannot repair mutated DNA.\n* The risk of cancer induction in infants receiving a single small dose of radiation is 2-3 times higher than the average population and 6-9 times higher than the risk from an exposure of a 60-year-old patient.\n* New imaging modalities have been introduced in clinical practice in recent years such as lung ultrasound.\n* One of the most common causes of neonatal respiratory distress that can be diagnosed by ultrasound is :Respiratory Distress Syndrome:\n\n * Respiratory distress syndrome.. is a major cause of neonatal mortality.\n * It mainly occur in preterm infants due to structural and functional lung immaturity.\n * Pulmonary surfactant insufficiency is an important pathogenesis in respiratory distress syndrome.\n * The ultrasonic features of respiratory distress syndrome are: Compact B-Lines, white lung appearance, abnormality in pleural line (thick and irregular),lung consolidation.\n* Lung ultrasound has the advantages of :\n\n * Non-ionizing.\n * Easy to operate.\n * Low coast.\n * Portable for bedside use.\n * The imaging is performed in real-time.\n* Thus making it as a potential tool to be used in neonatal intensive care units.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Nenates in the neonatal intensive care units who suffering from respiratory distress.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neonates in neonatal intensive care units\n\nExclusion Criteria:\n\n* Patients with poor-quality of lung ultrasound image.\n* Subcutaneous emphysema.'}, 'identificationModule': {'nctId': 'NCT06372951', 'briefTitle': 'Lung Ultrasound in Neonatal Intensive Care Units', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Role of Lung Ultrasound in Assessment of Neonatal Respiratory Distress', 'orgStudyIdInfo': {'id': 'Lung ultrasound in neonate'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasound', 'type': 'DEVICE', 'description': 'A device that use ultrasonic waves as a way to image the internal organs and tissues of the body in order to diagnose the different diseases.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Esraa Talat Fawzy, Master', 'role': 'CONTACT', 'email': 'esraatalat883@gmail.com', 'phone': '01061846361'}], 'overallOfficials': [{'name': 'Ihab Mansour Mohamed, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Kawsar Abdel Halim Mohamed, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Azhar Arabi Mohammed, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': ': Assistant Lecturer', 'investigatorFullName': 'Esraa Talat Fawzy', 'investigatorAffiliation': 'Assiut University'}}}}