Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT01517958
Status:
COMPLETED
Last Update Posted:
2016-03-25
First Post:
2012-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059245', 'term': 'Transient Tachypnea of the Newborn'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D012127', 'term': 'Respiratory Distress Syndrome, Newborn'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D059246', 'term': 'Tachypnea'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-24', 'studyFirstSubmitDate': '2012-01-20', 'studyFirstSubmitQcDate': '2012-01-24', 'lastUpdatePostDateStruct': {'date': '2016-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lung ultrasound', 'timeFrame': 'within first 24 hours of life.', 'description': 'The primary endpoint is to determine whether lung ultrasound is comparable or superior to chest radiography: (1) in making the diagnosis of RDS and TTN and (2) in differentiating between RDS and TTN.\n\nDisease-specific lung ultrasound findings: (1) Double lung point in TTN and (2) lung white-out in RDS.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Transient tachypnea of the newborn', 'Respiratory Distress Syndrome', 'Lung Ultrasound', 'Neonates'], 'conditions': ['Transient Tachypnea of the Newborn', 'TTN', 'Respiratory Distress Syndrome', 'RDS']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that ultrasonography of the newborn lung can be used as an effective diagnostic tool in neonates ≥ 28 weeks gestation with early symptoms of respiratory distress.', 'detailedDescription': 'Respiratory distress is a common reason for admission to the neonatal intensive care unit (NICU) for both preterm and full term newborns. TTN and RDS are the two most common diagnoses associated with respiratory distress. Due to their similar clinical presentations, it is often difficult to differentiate the two diseases clinically. Currently chest radiography is used to differentiate between TTN and RDS, however, radiographic findings are not always definitively diagnostic.\n\nIn preliminary studies, lung ultrasonography has been shown to be a useful tool in diagnosing both TTN and RDS. However, no one has looked at the use of lung ultrasonography in differentiating TTN from RDS in the neonatal population. We propose to do so in this study.\n\nPatients will be enrolled from neonatal admissions to the NICU with respiratory distress. Lung ultrasound will be performed on all enrolled subjects, looking for specific findings suggestive of either TTN or RDS. Data will be collected on gestational age, physical exam findings and level of respiratory support. Diagnoses will be recorded based on ultrasound findings. Accuracy of lung ultrasound diagnosis will be compared to that using radiographic chest radiography findings to evaluate if lung ultrasound is equivalent, or better than chest radiography in order to diagnose TTN versus RDS in this patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '28 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Neonatal patients admitted to Mount Sinai NICU of gestational age greater than or equal to 28 weeks.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gestational age ≥ 28 weeks\n* symptoms of respiratory distress defined as:\n* tachypnea (respiratory rate \\> 60 breaths per minute)\n* FiO2 requirement \\>21%\n* intercostal/subcostal retractions\n* grunting and/or nasal flaring\n* If clinically warranted, a chest x-ray will be done as part of the workup for respiratory distress; these patients with CXR will be included in the study.\n* Inclusion criteria for the control group will be gestational age ≥ 28 weeks with no symptoms of respiratory distress (defined above).\n\nExclusion Criteria:\n\n* neonates with prenatally diagnosed structural cardiac disease\n* major multiple congenital anomalies\n* other causes of respiratory distress that are not RDS or TTN (e.g. pneumothorax, CCAM or pneumonia).'}, 'identificationModule': {'nctId': 'NCT01517958', 'briefTitle': 'Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'The Use of Lung Ultrasound to Diagnose RDS vs. TTN in Neonates Greater Than or Equal to 28 Weeks Gestation', 'orgStudyIdInfo': {'id': 'GCO 11-0598'}, 'secondaryIdInfos': [{'id': 'IF#1289354'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Respiratory Distress Group', 'description': 'Neonates 28 weeks GA or greater with respiratory distress', 'interventionNames': ['Other: Respiratory Distress Group']}, {'label': 'Control Group', 'description': 'Neonates 28 weeks GA or greater without respiratory distress.', 'interventionNames': ['Other: Control Group']}], 'interventions': [{'name': 'Respiratory Distress Group', 'type': 'OTHER', 'otherNames': ['Diagnostic lung ultrasound.'], 'description': 'Diagnostic lung ultrasound.', 'armGroupLabels': ['Respiratory Distress Group']}, {'name': 'Control Group', 'type': 'OTHER', 'description': 'Lung ultrasound', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Ian Holzman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}