Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-29 @ 3:52 PM
Study NCT ID:
NCT01852461
Status:
COMPLETED
Last Update Posted:
2013-05-13
First Post:
2013-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perfusion Index Variability in Respiratory Distress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C072197', 'term': 'beractant'}, {'id': 'C068291', 'term': 'poractant alfa'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-10', 'studyFirstSubmitDate': '2013-05-07', 'studyFirstSubmitQcDate': '2013-05-10', 'lastUpdatePostDateStruct': {'date': '2013-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mortality', 'timeFrame': '4 weeks', 'description': 'The effects of the two treatment regimens on mortality were compared'}], 'primaryOutcomes': [{'measure': 'perfusion index', 'timeFrame': '1 week', 'description': 'PI and oxygen saturation (SpO2) were measured by "Masimo Rainbow SET Radical-7 pulse oximeter" before and after surfactant. The effects of the two treatment regimens on PI, oxygenation and clinical outcome were compared.'}], 'secondaryOutcomes': [{'measure': 'Duration of mechanical ventilation', 'timeFrame': '4 weeks', 'description': 'The effects of the two treatment regimens on duration of mechanical ventilation were compared'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['natural surfactants; perfusion index'], 'conditions': ['Poor Peripheral Perfusion']}, 'descriptionModule': {'briefSummary': 'Perfusion index may vary according to type of surfactant during the treatment of respiratory distress syndrome.', 'detailedDescription': 'Peripheral tissues of preterm infants are very sensitive for hypoperfusion, but there are rare data in the literature for peripheral perfusion after surfactant treatment. In this study the investigators aimed to compare the perfusion index (PI) variability in premature infants with respiratory distress (RDS) following instillation of one of two different natural surfactant preparations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Days', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* premature infants \\< 32 weeks of gestational age\n\nExclusion Criteria:\n\n* congenital malformation\n* Apgar scores \\<3 at 5 min'}, 'identificationModule': {'nctId': 'NCT01852461', 'briefTitle': 'Perfusion Index Variability in Respiratory Distress Syndrome', 'organization': {'class': 'OTHER', 'fullName': "Dr. Sami Ulus Children's Hospital"}, 'officialTitle': 'Perfusion Index Variability in Preterm Infants Treated With Two Different Natural Surfactants for Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': '685.114A'}, 'secondaryIdInfos': [{'id': 'Surfactant trial', 'type': 'OTHER', 'domain': 'SamiUlusCH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Beractant', 'description': 'Beractant;bovine lung extract; both initial and subsequent dosing is 100 mg/kg (4 mL/kg), which may be given every 6 hours up to four total doses', 'interventionNames': ['Drug: Beractant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Poractant alfa', 'description': 'Poractant alfa; porcine lung extract; initial dosing is 200 mg/kg (2.5 mL/kg) and repeated dosing is given at 100 mg/kg (1.25 mL/kg) every 12 hours, up to maximum of two additional doses when indicated', 'interventionNames': ['Drug: Poractant alfa']}], 'interventions': [{'name': 'Beractant', 'type': 'DRUG', 'otherNames': ['Beractant (Survanta)'], 'description': 'Beractant;both initial and subsequent dosing is 100 mg/kg (4 mL/kg), which may be given every 6 hours up to four total doses', 'armGroupLabels': ['Beractant']}, {'name': 'Poractant alfa', 'type': 'DRUG', 'otherNames': ['Poractant alfa (curosurf)'], 'description': 'porcine lung extract, initial dosing is 200 mg/kg (2.5 mL/kg) and repeated dosing is given at 100 mg/kg (1.25 mL/kg) every 12 hours, up to maximum of two additional doses when indicated', 'armGroupLabels': ['Poractant alfa']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dilek Dilli, Assoc Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sami Ulus CH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Dr. Sami Ulus Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assos Prof', 'investigatorFullName': 'Dilek Dilli', 'investigatorAffiliation': "Dr. Sami Ulus Children's Hospital"}}}}