Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2025-12-27 @ 9:10 PM
Study NCT ID:
NCT01439295
Status:
COMPLETED
Last Update Posted:
2015-11-18
First Post:
2011-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D012178', 'term': 'Retinopathy of Prematurity'}, {'id': 'D004374', 'term': 'Ductus Arteriosus, Patent'}, {'id': 'D007969', 'term': 'Leukomalacia, Periventricular'}], 'ancestors': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye 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': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004678', 'term': 'Encephalomalacia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Urine sample (650 µl) Blood sample (500 µl)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-17', 'studyFirstSubmitDate': '2011-09-16', 'studyFirstSubmitQcDate': '2011-09-22', 'lastUpdatePostDateStruct': {'date': '2015-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bronchopulmonary Dysplasia', 'timeFrame': '4 Months', 'description': 'To correlate the level of urinary Ascorbyl peroxide and BPD. Full diagnosis and classification (to mild, moderate or severe) is at 36 weeks of corrected age; so even for most premature infants (like 23 weeks of gestation) there will be a need for follow up for less than 4 month to have the final diagnosis at 36 weeks'}], 'secondaryOutcomes': [{'measure': 'The redox status (in blood)', 'timeFrame': 'First week of life (week 1) and 36 semaines CA', 'description': 'Testing the correlation between the urinary level of ascorbyl peroxide and the redox status in the blood at 5 to 7 days of life. Measuring the Redox potential at 36 weeks corrected age to investigate long term effect of early oxidative stress.'}, {'measure': 'Major neonatal outcomes (NEC, ROP, PDA, IVH, PVL)', 'timeFrame': '4 Months', 'description': 'These outcomes are the major neonatal outcomes for preterm infants, we would test the correlation between ascorbyl peroxide (as marker of oxidative stress) and like Necrotising enterocolotis (NEC), Retinopathy of prematurity (ROP),patent ductus arteriosis(PDA), intraventricular hemorrhage (IVH) and periventricular leucomalacia (PVL).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ascorbyl peroxide', 'Bronchopulmonary dysplasia', 'Redox status', 'Necrotising entercolitis', 'Retinopathy of prematurity', 'Patent ductus arteriosus', 'Intraventricular hemorrhage', 'Periventricular leucomalacia'], 'conditions': ['Bronchopulmonary Dysplasia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://journals.lww.com/pedresearch/Fulltext/2010/09000/Neonatal_Exposure_to_Oxidants_Induces_Later_in.2.aspx', 'label': 'Neonatal Exposure to Oxidants Induces Later in Life a Metabolic Response Associated to a Phenotype of Energy Deficiency in an Animal Model of Total Parenteral Nutrition'}, {'url': 'http://www.pediatricsdigest.mobi/content/99/3/e6.full', 'label': 'Admixture of a Multivitamin Preparation to Parenteral Nutrition: The Major Contributor to In Vitro Generation of Peroxides'}, {'url': 'http://journals.lww.com/pedresearch/pages/articleviewer.aspx?year=1998&issue=05000&article=00007&type=abstract', 'label': 'Paradoxical Role of Ascorbic Acid and Riboflavin in Solutions of Total Parenteral Nutrition: Implication in Photoinduced Peroxide Generation'}]}, 'descriptionModule': {'briefSummary': 'Urinary ascorbyl peroxide level in the first week of life will be a good predictor of Bronchopulmonary dysplasia (BPD) in preterm infants less than 33 weeks of gestation.', 'detailedDescription': "This study uses ascorbyl peroxide as representative of oxidative stress in premature infants on parenteral nutrition and aims to test the correlation of this metabolite and the different major neonatal outcomes 'mainly bronchopulmonary dysplasia)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '32 Weeks', 'minimumAge': '23 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm infants less than 33 weeks of getation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants less than 33 weeks of gestation\\<\n* Admission to CHU Sainte-JUstien neonatal intensive care unit\n* Receiving Parenteral nutrition during the first week of life\n* Parental consent\n\nExclusion Criteria:\n\n* Major congenital anomalies\n* Sever perinatal asphyxia'}, 'identificationModule': {'nctId': 'NCT01439295', 'briefTitle': 'Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia', 'organization': {'class': 'OTHER', 'fullName': "St. Justine's Hospital"}, 'officialTitle': 'Urinary Ascorbyl Peroxide as an Early Biological Marker of Bronchopulmonary Dysplasia in Preterm Infants Less Than 33 Weeks of Gestation', 'orgStudyIdInfo': {'id': 'University of Montreal'}, 'secondaryIdInfos': [{'id': 'CIHR246505', 'type': 'OTHER_GRANT', 'domain': 'Canadain Institute of Health Research (CIHR)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preterm less than 33 weeks', 'description': 'This cohort will be composed of premature infants born before 33 weeks of gestational age, admitted to the neonatal intensive care unit at Sainte-Justine hospital and receiving parenteral nutrition (PN) during their first week of life.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'University of Montreal, Sainte-Justine Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Ibrahim Mohamed, Mb CHB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Montreal, Sainte Justine Hospital'}, {'name': 'Jean-claude Lavoie, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Montreal, Sainte-Justine hospital research center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Justine's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct professor of peditarics, division of neonatology', 'investigatorFullName': 'Ibrahim Mohamed', 'investigatorAffiliation': "St. Justine's Hospital"}}}}