Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT00431418
Status:
COMPLETED
Last Update Posted:
2015-09-23
First Post:
2007-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-21', 'studyFirstSubmitDate': '2007-02-02', 'studyFirstSubmitQcDate': '2007-02-02', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of ventilation', 'timeFrame': '12 months after completion of study'}], 'secondaryOutcomes': [{'measure': 'Bronchopulmonary Dysplasia (BPD)', 'timeFrame': '12 months after completion of study'}]}, 'conditionsModule': {'conditions': ['Lung Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to investigate in a randomised double-blind trial whether treatment with Sildenafil reduces duration of ventilatory support in preterm infants born at 28 weeks of gestation or less.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborn babies born \\<28 weeks of gestation who still need ventilatory support via endotracheal tube or have been re-ventilated at day 7 of life.\n\nExclusion Criteria:\n\n* Congenital heart defects\n* Suspected inborn error of metabolism\n* Inhaled Nitric Oxide treatment during assessment'}, 'identificationModule': {'nctId': 'NCT00431418', 'briefTitle': 'The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease', 'organization': {'class': 'OTHER', 'fullName': 'Mercy Hospital for Women, Australia'}, 'officialTitle': 'The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease (SPICE Trial): a Pilot Study', 'orgStudyIdInfo': {'id': 'R 06/34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Sildenafil oral solution.', 'interventionNames': ['Drug: Sildenafil']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo oral solution.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sildenafil', 'type': 'DRUG', 'otherNames': ['Revatio(R)'], 'description': 'Sildenafil oral solution', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo solution', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3084', 'city': 'Heidelburg', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Mercy Hospital for Women'}], 'overallOfficials': [{'name': 'Kai König, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mercy Hospital for Women'}, {'name': 'Charles P Barfield, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mercy Hospital for Women'}, {'name': 'Chad C Andersen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mercy Hospital for Women'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mercy Hospital for Women, Australia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Neonatologist', 'investigatorFullName': 'Dr. Kai Konig', 'investigatorAffiliation': 'Mercy Hospital for Women, Australia'}}}}