Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-02 @ 10:39 AM
Study NCT ID:
NCT02396004
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2015-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NIRS in PDA VLBW Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-09', 'studyFirstSubmitDate': '2015-03-18', 'studyFirstSubmitQcDate': '2015-03-23', 'lastUpdatePostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cerebral oximetry', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'renal oximetry', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['PDA']}, 'descriptionModule': {'briefSummary': 'Aim of study:\n\nTo conduct an observational study to collect cerebral and renal perfusion data through NIRS before and after treatment of PDA by medication or by PDA ligation. The data post treatment would form the basis for normative baseline data in VLBW preterm newborn babies, particularly in the Asian population.\n\nStudy population/inclusion criteria:\n\nVLBW newborn babies with hemodynamically significant PDA by echocardiography.\n\nExclusion criteria:\n\nMajor malformations Moribund patients', 'detailedDescription': 'Aim of study:\n\nTo conduct an observational study to collect cerebral and renal perfusion data through NIRS before and after treatment of PDA by medication or by PDA ligation. The data post treatment would form the basis for normative baseline data in VLBW preterm newborn babies, particularly in the Asian population.\n\nStudy population/inclusion criteria:\n\nVLBW newborn babies with hemodynamically significant PDA by echocardiography.\n\nExclusion criteria:\n\nMajor malformations Moribund patients\n\nProtocol:\n\nConsent will be obtained from parents of eligible newborns before treatment of hemodynamic significant PDA. To attach cerebral and renal oximeter by NIRS to these VLBW infants with PDAs for until 24 hours post closure of PDA. Doppler ultrasound will be performed on anterior cerebral artery (ACA) and/or middle cerebral artery (MCA) artery and/or renal artery(RA) before PDA treatment and/or 24hours after PDA closure.This study aims to use one of the more popular neonatal/paediatrics NIRS machine, which is the INVOS cerebral/somatic oximeter\n\nThe same patient will hence form its own control after treatment. Echocardiographic follow-up or clinical assessment for closure of the PDA will be performed 24-48 hours after the course of medication or surgical closure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'VLBW (defined as birthweight less than 1500g) infants with hemodynamically significant PDA (patent ductus arteriosus) requiring treatment, either medical or surgical', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* VLBW infants with hemodynamically significant PDA by echocardiography\n\nExclusion Criteria:\n\n* Major malformation\n* Moribund'}, 'identificationModule': {'nctId': 'NCT02396004', 'briefTitle': 'NIRS in PDA VLBW Infants', 'organization': {'class': 'OTHER', 'fullName': 'Singapore General Hospital'}, 'officialTitle': 'Near-Infrared Red Spectroscopy (NIRS) to Measure Cerebral Perfusion During and After Patent Ductus Arteriosus (PDA) Treatment in Very Low Birth Weight (VLBW) Infants', 'orgStudyIdInfo': {'id': 'CIRB 2013/379/E'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Near Infrared Red Spectroscopy (NIRS)', 'type': 'DEVICE', 'description': 'NIRS using INVOS cerebral/somatic oximeter'}]}, 'contactsLocationsModule': {'locations': [{'zip': '169608', 'city': 'Singapore', 'state': 'Singapore', 'country': 'Singapore', 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Woei Bing Poon, MRCPCH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Singapore General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singapore General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}