Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT04295395
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2020-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Brain and Renal Regional Oxygenation Using NIRS in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D004374', 'term': 'Ductus Arteriosus, Patent'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-03', 'studyFirstSubmitDate': '2020-02-19', 'studyFirstSubmitQcDate': '2020-03-03', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences of the mean values of regional oxygenation of the brain and renal', 'timeFrame': 'from Day 4 of live up to 36 weeks', 'description': 'Cerebral and renal regional tissue oxygen saturation monitoring on the day after echocardiography was done'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['near-infrared spectroscopy', 'preterm infant', 'echocardiography'], 'conditions': ['Pre-Term', 'Persistent Ductus Arteriosus']}, 'referencesModule': {'references': [{'pmid': '34886825', 'type': 'DERIVED', 'citation': 'Navikiene J, Virsilas E, Vankeviciene R, Liubsys A, Jankauskiene A. Brain and renal oxygenation measured by NIRS related to patent ductus arteriosus in preterm infants: a prospective observational study. BMC Pediatr. 2021 Dec 9;21(1):559. doi: 10.1186/s12887-021-03036-w.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the brain and renal oxygenation using near infrared spectroscopy in preterm infants with persistent ductus arteriosus', 'detailedDescription': 'Patent ductus arteriosus (PDA) is common in preterm infants. In the presence of a large PDA, significant systemic to pulmonary shunting occurs, which may result in pulmonary hyperperfusion and systemic hypoperfusion.\n\nThe evidence on PDA effect on brain and renal tissue oxygenation, measured by Near Infrared Spectroscopy is still controversial.\n\nThis study aims to evaluate the brain and renal oxygenation using near infrared spectroscopy (NONIN SenSmart model X-100) in 3 groups of preterm infants: 1) closed ductus arteriosus, 2) persistent ductus arteriosus, 3) hemodynamicaly significant ductus arteriosus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '32 Weeks', 'minimumAge': '22 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm infants with gestation age of \\< 32 weeks, birth weight \\< 1500g, \\> 72 hours of age, will have NIRS monitors placed to measure cerebral and renal regional tissue oxygenation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preterm infants with gestation age of \\< 32 weeks\n* birth weight \\< 1500g\n* \\> 72 hours of age.\n\nExclusion Criteria:\n\n* cardiovascular, renal, cerebral congenital defects,\n* confirmed sepsis,\n* no parental consent'}, 'identificationModule': {'nctId': 'NCT04295395', 'briefTitle': 'Evaluation of the Brain and Renal Regional Oxygenation Using NIRS in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Vilnius University'}, 'officialTitle': 'Evaluation of the Brain and Renal Regional Oxygenation Using Near Infrared Spectroscopy (NIRS) Method in Very Low Birth Weight (<1500 g) Infants', 'orgStudyIdInfo': {'id': 'AIRS-2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group1', 'description': 'preterm infant with closed ductus arteriosus, \\<32 weeks birth weight \\< 1500g, and \\> 72 hours of age', 'interventionNames': ['Device: NONIN SenSmart model X-100 near- infrared spectrometer']}, {'label': 'group2', 'description': 'preterm infant with PDA \\< 32 weeks, birth weight \\< 1500g, and \\> 72 hours of age', 'interventionNames': ['Device: NONIN SenSmart model X-100 near- infrared spectrometer']}, {'label': 'group3', 'description': 'preterm infant with hemodynamically significant PDA \\< 32 weeks, birth weight \\< 1500g, and \\> 72 hours of age', 'interventionNames': ['Device: NONIN SenSmart model X-100 near- infrared spectrometer']}], 'interventions': [{'name': 'NONIN SenSmart model X-100 near- infrared spectrometer', 'type': 'DEVICE', 'otherNames': ['GE LOGIQ S8 XDclear 2.0 ultrasoud'], 'description': 'for to measure cerebral (cSO2) and renal (rSO2 ) regional tissue oxygen saturation on the day after echocardiography was done. The sensors were placed on the right/left forehead and the right/left lateral posterior flank', 'armGroupLabels': ['group1', 'group2', 'group3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08406', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Vilnius University Santaros Klinikos Neonatology Center', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}], 'overallOfficials': [{'name': 'Augustina Jankauskiene, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vilnius University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vilnius University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}