Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 3:52 AM
Study NCT ID:
NCT05857293
Status:
UNKNOWN
Last Update Posted:
2023-05-12
First Post:
2023-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PDA Stent in Neonates With PDA Dependent Pulmonary Circulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2023-05-02', 'studyFirstSubmitQcDate': '2023-05-10', 'lastUpdatePostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Oxygen saturation', 'timeFrame': 'Change in oxygen saturation within 24 hours', 'description': 'Using pulse oximeter to assess oxygen saturation'}, {'measure': 'Evaluation of duct patency', 'timeFrame': '1 month', 'description': 'Using echocardiography assess flow through the duct'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neonatal Cyanosis Due to PDA Dependent Pulmonary Circulation']}, 'descriptionModule': {'briefSummary': "After echocardiography confirmation of PDA dependent pulmonary circulation in cyanotic neonates, catheter-guided PDA stent implantation will be done. Under general Anasthesia and after discontinuation of prostaglandin 4-6 hours before procedure, obtain vascular access and unfractionated heparin is given, then duct is accessed via a cut pig-tail or Judkins right \\[JR\\] catheter, and is crossed by PTCA wire to be carefully placed in the left or right branch pulmonary arteries, choose proper stent diameter and length, place the stent and confirm it's position, NICU admission for the neonate with heparin infusion for 24-48 hrs and acetylsalicylic acid is given then follow up the patient by pulse oximeter and echocardiography"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Months', 'minimumAge': '1 Hour', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNeonates and young infants with duct dependent pulmonary circulation\n\nExclusion Criteria:\n\n* Untreated sepsis.\n* Coagulopathy.\n* PDA dependent systemic circulation.'}, 'identificationModule': {'nctId': 'NCT05857293', 'briefTitle': 'PDA Stent in Neonates With PDA Dependent Pulmonary Circulation', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Outcomes for Patent Ductus Arteriosus Stenting in Neonates With Duct-Dependent Pulmonary Circulation: A Prospective Study at Sohag University Hospital', 'orgStudyIdInfo': {'id': 'Soh-Med-23-04-03MD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cyanotic neonate', 'description': 'Cyanotic neonates with PDA dependent pulmonary circulation will be treated with catheter guided PDA stent implantation to keep duct patency and improve oxygen saturation', 'interventionNames': ['Device: Catheter-guided PDA stent implantation']}], 'interventions': [{'name': 'Catheter-guided PDA stent implantation', 'type': 'DEVICE', 'otherNames': ['PDA stent'], 'description': 'PDA stent is the primary treatment for patients with duct-dependent pulmonary circulation. It serves as a temporary bridge for later surgical repair by keeping the duct patent to improve oxygen saturation', 'armGroupLabels': ['Cyanotic neonate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Somaia S Mahmoud, Master', 'role': 'CONTACT', 'email': 'somaia_sabry922@yahoo.com', 'phone': '201019052097'}], 'facility': 'Sohag University', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Somaia S Mahmoud, Master', 'role': 'CONTACT', 'email': 'somaia_sabry922@yahoo.com', 'phone': '201019052097'}], 'overallOfficials': [{'name': 'Somaia S Mahmoud, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Somia Sabry Mahmoud', 'investigatorAffiliation': 'Sohag University'}}}}