Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-01 @ 2:28 AM
Study NCT ID:
NCT01329432
Status:
UNKNOWN
Last Update Posted:
2011-04-06
First Post:
2011-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surfactant Administration During Spontaneous Breathing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011030', 'term': 'Pneumothorax'}, {'id': 'D008478', 'term': 'Mediastinal Emphysema'}, {'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008477', 'term': 'Mediastinal Diseases'}, {'id': 'D013896', 'term': 'Thoracic Diseases'}, {'id': 'D004646', 'term': 'Emphysema'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C096479', 'term': 'Insure Cement'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-05', 'studyFirstSubmitDate': '2011-04-01', 'studyFirstSubmitQcDate': '2011-04-05', 'lastUpdatePostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'nasal cPAP failure and need for mechanical ventilation within 72 hours', 'timeFrame': 'first 72 hours'}], 'secondaryOutcomes': [{'measure': 'incidence of bronchopulmonary dysplasia', 'timeFrame': '8-10 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['surfactant', 'intubation', 'spontaneous breathing', 'bronchopulmonary dysplasia'], 'conditions': ['Pneumothorax', 'Pulmonary Interstitial Emphysema', 'Bronchopulmonary Dysplasia']}, 'referencesModule': {'references': [{'pmid': '20084586', 'type': 'RESULT', 'citation': 'Kribs A, Hartel C, Kattner E, Vochem M, Kuster H, Moller J, Muller D, Segerer H, Wieg C, Gebauer C, Nikischin W, Wense Av, Herting E, Roth B, Gopel W. Surfactant without intubation in preterm infants with respiratory distress: first multi-center data. Klin Padiatr. 2010 Jan-Feb;222(1):13-7. doi: 10.1055/s-0029-1241867. Epub 2010 Jan 18.'}]}, 'descriptionModule': {'briefSummary': 'Spontaneous breathing supported by nasal continuous positive airway pressure (nCPAP) is thought to have some advantages compared with mechanical ventilation in premature infants. In addition, early surfactant administration has been shown to be superior to delayed use. The aim of this pilot study was to describe the feasibility of TAKE CARE (early administration of surfactant in spontaneous breathing) procedure and compare its short-term and long-term results with InSurE procedure.', 'detailedDescription': 'In TAKE CARE procedure all premature infants who suffered from respiratory distress syndrome (RDS) received 100 mg/kg of porcine surfactant preparation via an intratracheal catheter during spontaneous breathing. In the control group infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration. The procedures were compared for short-term efficacy and possible complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '35 Weeks', 'minimumAge': '23 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All infants who presented with clinical anl laboratory signs of RDS\n\nExclusion Criteria:\n\n* infants who required intubation or PPV right after birth'}, 'identificationModule': {'nctId': 'NCT01329432', 'acronym': 'TAKE CARE', 'briefTitle': 'Surfactant Administration During Spontaneous Breathing', 'organization': {'class': 'OTHER', 'fullName': "Zekai Tahir Burak Women's Health Research and Education Hospital"}, 'officialTitle': 'Early Administration of Surfactant in Spontaneous Breathing (TAKE CARE) Versus InSurE (Intubation, Surfactant, Extubation) : A Pilot Study', 'orgStudyIdInfo': {'id': '2011-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'take care', 'description': 'In TAKE CARE procedure all premature infants who suffered from respiratory distress syndrome (RDS) received 100 mg/kg of porcine surfactant preparation via an intratracheal catheter during spontaneous breathing', 'interventionNames': ['Procedure: Take care']}, {'type': 'EXPERIMENTAL', 'label': 'InSurE', 'description': 'infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration', 'interventionNames': ['Procedure: InSurE']}], 'interventions': [{'name': 'Take care', 'type': 'PROCEDURE', 'description': 'In TAKE CARE procedure all premature infants who suffered from respiratory distress syndrome (RDS) received 100 mg/kg of porcine surfactant preparation via an intratracheal catheter during spontaneous breathing.', 'armGroupLabels': ['take care']}, {'name': 'InSurE', 'type': 'PROCEDURE', 'description': 'infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration.', 'armGroupLabels': ['InSurE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Gozde Kanmaz, MD', 'role': 'CONTACT', 'email': 'gzdekanmaz@yahoo.com', 'phone': '+ 90 505 588 11 89'}, {'name': 'Omer Erdeve, MD', 'role': 'CONTACT', 'email': 'omererdeve@yahoo.com', 'phone': '+90 312 306 56 76'}, {'name': 'Gozde Kanmaz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Banu Mutlu, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Zekai tahir Burak Materntiy Teaching Hospital, Neonatal Intensive Care Unit', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Gozde Kanmaz, MD', 'role': 'CONTACT', 'email': 'gzdekanmaz@yahoo.com', 'phone': '+90 505 588 11 89'}, {'name': 'Omer Erdeve, MD', 'role': 'CONTACT', 'email': 'omererdeve@yahoo.com', 'phone': '+90 312 306 56 76'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Zekai Tahir Burak Women's Health Research and Education Hospital", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Gozde Kanmaz, MD', 'oldOrganization': 'Zekai Tahir Burak Maternity Teaching Hospital, Neonatal Intensive care Unit'}}}}