Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-01-02 @ 2:50 AM
Study NCT ID:
NCT03942757
Status:
COMPLETED
Last Update Posted:
2020-03-23
First Post:
2019-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D007567', 'term': 'Jaundice, Neonatal'}, {'id': 'D007565', 'term': 'Jaundice'}], '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': 'D051556', 'term': 'Hyperbilirubinemia, Neonatal'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006932', 'term': 'Hyperbilirubinemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010789', 'term': 'Phototherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-20', 'studyFirstSubmitDate': '2019-05-02', 'studyFirstSubmitQcDate': '2019-05-07', 'lastUpdatePostDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in bilirubin serum level (μmol/L/h)', 'timeFrame': 'before and 24 hours after start of phototherapy treatment', 'description': 'Change in bilirubin serum level (μmol/L/h) = (end bilirubin (μmol/L) - start bilirubin (μmol/L)) / delay between the 2 measurements (h)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preterm infant', 'jaundice', 'bilirubin', 'phototherapy', 'educational program'], 'conditions': ['Preterm Infant', 'Jaundice, Neonatal', 'Phototherapy']}, 'descriptionModule': {'briefSummary': 'Phototherapy is routinely used in neonatal intensive care units for the treatment of jaundice. Guidelines focus mainly on bilirubin serum levels to start the phototherapy. Only few data are available about clinical management of phototherapy devices and subsequently the impact on bilirubin serum decrease. Especially there are no strong recommendations about phototherapy duration, irradiance measurements, incubator temperature and humidity settings. Various factors can influence irradiance and thus the preterm infant bilirubin serum decrease. This study aims at evaluating the impact of an educational program on the use and efficacy of phototherapy in a neonatal intensive care unit.', 'detailedDescription': 'Only few data are available about clinical management of phototherapy devices for the treatment of jaundice in the preterm infant.\n\nThis study is a prospective, monocentric, observational study. Preterm infant \\< 35 weeks of gestation with a jaundice requiring phototherapy according to NICE guidelines can be included for the duration of the phototherapy treatment.\n\nThe decrease in bilirubin serum level before and after phototherapy treatment will be measured.\n\nThis decrease in bilirubin serum level will be assessed for two consecutive periods before and after an educational program on jaundice management of the preterm infant.\n\nThe investigators aim at demonstrating that an educational program could improve phototherapy management and result in a higher decrease in bilirubin serum during treatment of the preterm infant with jaundice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prospective, monocentric, observational study. All the preterm infant with a jaundice requiring a treatment with phototherapy could been screened for eligibility criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preterm infant less than 35 weeks gestation\n* preterm infant hospitalized in the neonatal intensive care unit of CHU Amiens-Picardie\n* preterm infant placed in an incubator\n* preterm infant with a jaundice requiring treatment according to NICE guidelines\n* preterm infant with a no hemolytic disease\n* preterm infant with informed written consent from the parents\n\nExclusion Criteria:\n\n* preterm infant more than 35 weeks of gestation\n* preterm infant with hemolytic disease\n* preterm infant with Jaundice related to a cholestasis\n* Jaundice requiring exchange transfusion'}, 'identificationModule': {'nctId': 'NCT03942757', 'acronym': 'BLUE', 'briefTitle': 'BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator', 'orgStudyIdInfo': {'id': 'PI2018_843_0021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'observation before educational program', 'description': '100 preterm infant medical records will be studied in a first part of this observational study', 'interventionNames': ['Other: bilirubin serum level determination', 'Other: Phototherapy']}, {'label': 'Observation after educational program', 'description': 'An educational program will be implemented in the unit after this first period. 100 preterm infant will be included in a second part of this observational study.', 'interventionNames': ['Other: bilirubin serum level determination', 'Other: Phototherapy']}], 'interventions': [{'name': 'bilirubin serum level determination', 'type': 'OTHER', 'description': 'bilirubin serum level before and after phototherapy treatment will be measured', 'armGroupLabels': ['Observation after educational program', 'observation before educational program']}, {'name': 'Phototherapy', 'type': 'OTHER', 'description': 'Preterm infant \\< 35 weeks of gestation with a jaundice requiring phototherapy according to NICE guidelines can be included for the duration of the phototherapy treatment.', 'armGroupLabels': ['Observation after educational program', 'observation before educational program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80480', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}