Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-02-25 @ 11:01 PM
Study NCT ID:
NCT03165305
Status:
COMPLETED
Last Update Posted:
2019-08-13
First Post:
2017-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Sustained Inflation on Short Term Respiratory Outcomes in Term Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012127', 'term': 'Respiratory Distress Syndrome, Newborn'}, {'id': 'D059245', 'term': 'Transient Tachypnea of the Newborn'}], 'ancestors': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D059246', 'term': 'Tachypnea'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2017-05-23', 'studyFirstSubmitQcDate': '2017-05-23', 'lastUpdatePostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory Morbidity', 'timeFrame': '2 hours', 'description': 'RDS, TTN, requirement for supplemental oxygen, intubation or mechanical ventilation support'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Distress Syndrome, Newborn', 'Transient Tachypnea of the Newborn', 'Respiratory Morbidity']}, 'descriptionModule': {'briefSummary': 'Sustained inflation (SI) has been reported to be effective for reducing the need for intubation and/or invasive ventilation in preterm infants. However, it has also an important role to support the initial breaths and liquid removal from the airways. Therefore, the investigators hypothesized that SI performed just after birth may help to facilitate the transitional period and decrease the incidence of early respiratory morbidities such as transient tachypnea in term infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Minutes', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* term newborns\n* parental informed consent\n* inborn infants\n\nExclusion Criteria:\n\n* major congenital/chromosomal abnormalities\n* lack of informed consent\n* outborn infants\n* Premature infants'}, 'identificationModule': {'nctId': 'NCT03165305', 'briefTitle': 'The Role of Sustained Inflation on Short Term Respiratory Outcomes in Term Infants', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'The Role of Sustained Inflation on Short Term Respiratory Outcomes in Term Infants', 'orgStudyIdInfo': {'id': '123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sustained Inflation Group', 'description': 'Includes the infants who administered sustained inflation for 5 seconds with a pressure of 30cm H20 immediately after the delivery.', 'interventionNames': ['Other: Sustained Inflation']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention group', 'description': 'Includes routine neonatal care in the delivery room'}], 'interventions': [{'name': 'Sustained Inflation', 'type': 'OTHER', 'description': 'Administering a pressure of 30 cm H20 by a T-piece resuscitator for 5 seconds immediately after birth.', 'armGroupLabels': ['Sustained Inflation Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni Sultan Suleyman Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Merih Cetinkaya', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, MD,PhD', 'investigatorFullName': 'Merih Cetinkaya', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}