Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-28 @ 10:49 PM
Study NCT ID:
NCT06207994
Status:
RECRUITING
Last Update Posted:
2025-03-25
First Post:
2023-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRICO: OPTI Target Range
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001261', 'term': 'Pulmonary Atelectasis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Subjects will be switched between the standard target range, the narrow target range, and the target range with a higher median every 12 hours. The sequence will be randomized differently for each subject, with a balanced block design such that every 3 days each range is evaluated twice.\n\nOnce enrolled, each subject will continue in the study with regular changes in averaging time through the course of their need for A-FiO2 or 30 days, whichever is shorter. All other elements of care will be as routinely used.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2023-12-18', 'studyFirstSubmitQcDate': '2024-01-04', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Associated effects', 'timeFrame': '30 days of intervention if possible', 'description': 'Effects associated with the mode of ventilation and set SpO2 control (based on gestational age) will be explored. The effects will be treated as covariables in a multivariate linear regression model with SpO2 target range compliance as a dependent variable.'}, {'measure': 'Stability', 'timeFrame': '30 days of intervention if possible', 'description': 'Effects associated with infant stability will be explored. The stability will be assessed based on the mean time in the SpO2 target range.'}], 'primaryOutcomes': [{'measure': 'Percent time in the set SpO2 target range', 'timeFrame': '30 days of intervention if possible', 'description': 'Percent time in the set SpO2 target range (compliance). Periods with SpO2 higher than the target range with FiO2 = 0.21 will be included in the target range compliance.'}, {'measure': 'Percent time at SpO2 ≤80% and >98%', 'timeFrame': '30 days of intervention if possible', 'description': 'Percent time at SpO2 ≤80% and \\>98% (safety). Periods with SpO2 higher than 98% with FiO2 = 0.21 will be excluded.'}], 'secondaryOutcomes': [{'measure': 'Percent time above the set SpO2 target range', 'timeFrame': '30 days of intervention if possible', 'description': 'Percent time above the set SpO2 target range. Periods with SpO2 higher than the target range with FiO2 = 0.21 will be excluded from time above the target range.'}, {'measure': 'Percent time below the set SpO2 target range', 'timeFrame': '30 days of intervention if possible', 'description': 'Percent time below the set SpO2 target range.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SpO2 Target Range', 'pulse oximetry', 'automatic oxygen control'], 'conditions': ['Neonatal Respiratory Distress', 'Very Low Birth Weight Infant']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to determine if a narrower SpO2 Target Range setting automated control of FiO2 (A-FiO2) is more effective than a wider SpO2 Target Range', 'detailedDescription': "A-FiO2 systems have consistently proven to be more effective than manual control. Because it is more precise than manual control, studies of some A-FiO2 systems found small differences in the set target range (shift in the median and width) can optimize the relative performance. Similar studies of the A-FiO2 system (PRICO) used in the investigator's NICU have not been conducted.\n\nThe standard of practice in the investigator's NICU is to use 4 different target ranges to balance the risk of hypoxia and hyperoxia based on the gestational age vulnerabilities. Based on the studies of other A-FiO2 systems the investigators believe a slightly narrower width target range would be more effective. Therefore, a small systematic study is needed to determine the optimal set target range to achieve the therapeutic goal."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All VLBW on respiratory support and oxygen requirements after 2 weeks of age in the NICU are eligible after informed consent is obtained.\n\nExclusion Criteria:\n\n* Informed consent is not obtained\n* Recording device for automated control of FiO2 is not available'}, 'identificationModule': {'nctId': 'NCT06207994', 'acronym': 'POSTR', 'briefTitle': 'PRICO: OPTI Target Range', 'organization': {'class': 'OTHER', 'fullName': 'Czech Technical University in Prague'}, 'officialTitle': 'Evaluation of the Impact of a Narrower SpO2 Target Range on Performance of an Automatic FiO2 Control System: a Randomized Study', 'orgStudyIdInfo': {'id': 'PricoOptiTR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Target Range', 'description': 'The SpO2 TR width is set to 5% SpO2, as is routine in the department. The actual TR will vary depending on the GA, as is standard practice in the department.'}, {'type': 'EXPERIMENTAL', 'label': 'Narrow Target Range', 'description': 'The SpO2 TR width is set narrower than the Standard TR. The actual TR will vary depending on the GA, as is standard practice in the department.', 'interventionNames': ['Device: Narrow TR']}, {'type': 'EXPERIMENTAL', 'label': 'Shifted Target Range', 'description': 'The SpO2 TR width is set as the Standard TR. The median of the TR is shifted up compared to the Standard TR. The actual TR will vary depending on the GA, as is standard practice in the department.', 'interventionNames': ['Device: Shifted TR']}], 'interventions': [{'name': 'Narrow TR', 'type': 'DEVICE', 'description': 'The width of the PRICO SpO2 TR is set to 3% SpO2.', 'armGroupLabels': ['Narrow Target Range']}, {'name': 'Shifted TR', 'type': 'DEVICE', 'description': 'The lower and the upper limits of the PRICO SpO2 TR are increased by 1% SpO2.', 'armGroupLabels': ['Shifted Target Range']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15500', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Jan Janota, PhD', 'role': 'CONTACT', 'email': 'jan.janota@fnmotol.cz'}], 'facility': 'Motol University Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'centralContacts': [{'name': 'Jakub Rafl, PhD', 'role': 'CONTACT', 'email': 'rafl@fbmi.cvut.cz', 'phone': '+420728229991'}], 'overallOfficials': [{'name': 'Ekaterina Orlova, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Motol University Hospital Prague, Neonatal Unit'}, {'name': 'Jan Janota, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Motol University Hospital Prague, Neonatal Unit'}, {'name': 'Thomas E Bachman, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Czech Technical University in Prague'}, {'name': 'Jana Dornakova, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Motol University Hospital Prague, Neonatal Unit'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The IPD will be made available upon reasonable request in a deidentified, HIPAA-compliant form.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Czech Technical University in Prague', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Motol', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}