Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-27 @ 4:10 PM
Study NCT ID:
NCT05036161
Status:
UNKNOWN
Last Update Posted:
2021-09-24
First Post:
2021-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ROX Index and ROX Vector to Predict Nasal High Flow / Continuous Positive Airway Pressure Failure in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-19', 'studyFirstSubmitDate': '2021-08-09', 'studyFirstSubmitQcDate': '2021-08-30', 'lastUpdatePostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants requiring escalation of treatment', 'timeFrame': '72 hours', 'description': 'Treatment failure criteria is reached once an infant is receiving maximal therapy for their treatment (NHF 8 L/min) or CPAP 7 cm H2O plus at least one of:\n\n1. Sustained increase in oxygen requirement above ≥50% to maintain peripheral oxygen saturation (SpO2) 90%-94%.\n2. Any infant requiring urgent intubation and the subsequent mechanical ventilation, as determined by the physician.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with death', 'timeFrame': 'Monitored for the entire stay in hospital, until discharge, up to 6 months', 'description': 'Death before discharge from the hospital'}, {'measure': 'Number of participants with pneumothorax', 'timeFrame': 'Monitored for the entire stay in hospital, until discharge, up to 6 months', 'description': 'Pneumothorax determined by chest radiograph'}, {'measure': 'Number of participants with Necrotizing enterocolitis stage II-III', 'timeFrame': 'Monitored for the entire stay in hospital, until discharge, up to 6 months', 'description': 'Necrotizing enterocolitis determined by abdominal radiograph'}, {'measure': 'Number of participants with Intra-ventricular hemorrhage', 'timeFrame': 'Monitored for the entire stay in hospital, until discharge, up to 6 months', 'description': 'Intra ventricular hemorrhage confirmed by head ultrasound'}, {'measure': 'Number of participants with Bronchopulmonary dysplasia', 'timeFrame': 'through study completion, up to 6 months', 'description': 'Bronchopulmonary dysplasia'}, {'measure': 'Number of participants with Cystic Periventricular Leukomalacia', 'timeFrame': 'Monitored for the entire stay in hospital, until discharge, up to 6 months', 'description': 'Cystic Periventricular Leukomalacia confirmed by ultrasound'}, {'measure': 'Number of participants with PDA needed surgical treatment', 'timeFrame': 'Monitored for the entire stay in hospital, until discharge, up to 6 months', 'description': 'Patent ductus arteriosus'}, {'measure': 'Number of participants with ROP needing laser treatment', 'timeFrame': 'Monitored for the entire stay in hospital, until discharge, up to 6 months', 'description': 'Retinopathy of prematurity needing laser treatment'}, {'measure': 'Number of participants requiring blood transfusion', 'timeFrame': 'Monitored for the entire stay in hospital, until discharge, up to 6 months', 'description': 'Blood transfusion'}, {'measure': 'total number of days on O2 / noninvasive ventilation', 'timeFrame': 'Monitored for the entire stay in hospital, until discharge, up to 6 months', 'description': 'total number of days on O2 / noninvasive ventilation'}, {'measure': 'Total number days in the hospital', 'timeFrame': 'Monitored for the entire stay in hospital, until discharge, up to 6 months', 'description': 'Total number days in the hospital'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nasal high flow', 'NHF', 'CPAP', 'ROX', 'neonatal', 'newborn', 'respiratory distress', 'treatment failure'], 'conditions': ['Predictive Value of Tests']}, 'referencesModule': {'references': [{'pmid': '21278432', 'type': 'BACKGROUND', 'citation': 'Fuchs H, Lindner W, Leiprecht A, Mendler MR, Hummler HD. Predictors of early nasal CPAP failure and effects of various intubation criteria on the rate of mechanical ventilation in preterm infants of <29 weeks gestational age. Arch Dis Child Fetal Neonatal Ed. 2011 Sep;96(5):F343-7. doi: 10.1136/adc.2010.205898. Epub 2011 Jan 30.'}, {'pmid': '27481760', 'type': 'BACKGROUND', 'citation': 'Roca O, Messika J, Caralt B, Garcia-de-Acilu M, Sztrymf B, Ricard JD, Masclans JR. Predicting success of high-flow nasal cannula in pneumonia patients with hypoxemic respiratory failure: The utility of the ROX index. J Crit Care. 2016 Oct;35:200-5. doi: 10.1016/j.jcrc.2016.05.022. Epub 2016 May 31.'}, {'pmid': '30576221', 'type': 'BACKGROUND', 'citation': 'Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernandez G, Garcia-de-Acilu M, Frat JP, Masclans JR, Ricard JD. An Index Combining Respiratory Rate and Oxygenation to Predict Outcome of Nasal High-Flow Therapy. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1368-1376. doi: 10.1164/rccm.201803-0589OC.'}, {'pmid': '30896967', 'type': 'BACKGROUND', 'citation': 'Tatkov S. Nasal High-Flow Therapy: Role of FiO2 in the ROX Index. Am J Respir Crit Care Med. 2019 Jul 1;200(1):115-116. doi: 10.1164/rccm.201902-0376LE. No abstract available.'}, {'pmid': '31635954', 'type': 'BACKGROUND', 'citation': 'Tatkov S. ROX vector to complement ROX index during nasal high flow therapy of hypoxemic patients. J Crit Care. 2020 Aug;58:129. doi: 10.1016/j.jcrc.2019.08.012. Epub 2019 Oct 18. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Nasal continuous positive airway pressure (CPAP) and Nasal High Flow (NHF) therapy are two primary therapies for the treatment of respiratory distress in newborns. However, a considerable number of infants, who are initially treated with CPAP and NHF, will develop worsening respiratory failure and eventually require intubation for mechanical ventilation and the administration of surfactant. Infants who fail noninvasive respiratory therapy may suffer the consequences of delayed intubation, surfactant administration and other adverse outcomes. The most challenging decisions in the management of respiratory distress after birth is to decide when to move from a noninvasive respiratory support to invasive mechanical ventilation and give surfactant to decrease pulmonary damage and improve outcomes. There are no clinically adequate predictors of early CPAP failure at the time of admission to the neonatal intensive care unit. Many measurements have been investigated for their ability to predict CPAP failure in infants such as fraction of inspired oxygen (FiO2), partial pressure of oxygen (PaO2), PaO2/FiO2 and the stable micro bubble test as soon as possible after birth. Roca and colleagues first established the ROX index to predict the success of NHF therapy in adults with pneumonia. The ROX index combines three common measurements: FiO2, peripheral oxygen saturation (SpO2) and respiratory rate. Combining the ROX values with the change in the respiratory rate and FiO2 can indicate whether escalation is required. It was proposed that XY plot of the key components of ROX may show the direction of changes in vector form.\n\nThe investigators hypothesized that the ROX index and ROX vector can be used for predicting the failure of CPAP and NHF in neonates.', 'detailedDescription': 'The objective is to explore the usefulness of ROX index to predict treatment failure of NHF and CPAP therapies in neonates.\n\nThe primary outcome is treatment failure within 72 h after start of the therapy with NHF or CPAP\n\nTreatment failure criteria is reached once an infant is receiving maximal therapy for their treatment (NHF 8 L/min) or CPAP 7 cm H2O plus at least one of:\n\n1. Sustained increase in oxygen requirement ≥50% to maintain peripheral oxygen saturation (SpO2) 90%-94%.\n2. Any infant requiring urgent intubation and the subsequent mechanical ventilation, as determined by the physician.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Hours', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'neonates with respiratory distress', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* They are admitted to a NICU when \\<24 h old, AND\n* The decision has been made by the attending clinician, to commence or continue (from stabilization at birth) non-invasive respiratory support (this does not include the provision of supplemental oxygen alone), AND\n* They have not previously been intubated or received surfactant\n\nExclusion criteria:\n\n* They immediately require intubation and ventilation (determined by attending clinician), OR\n* They already satisfy 'treatment failure' criteria, OR\n* They have a known major congenital anomaly or air leak"}, 'identificationModule': {'nctId': 'NCT05036161', 'briefTitle': 'ROX Index and ROX Vector to Predict Nasal High Flow / Continuous Positive Airway Pressure Failure in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Erebouni Medical Center'}, 'officialTitle': 'ROX Index and ROX Vector to Predict Nasal High Flow / Continuous Positive Airway Pressure Failure in Neonates', 'orgStudyIdInfo': {'id': 'N 6-2/2, 2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Predicting treatment failure of Nasal High Flow in newborns', 'description': 'newborns with respiratory distress treated with NHF', 'interventionNames': ['Other: Nasal high flow']}, {'label': 'Predicting treatment failure of Continuous Positive Airway Pressure in newborns', 'description': 'newborns with respiratory distress treated with CPAP', 'interventionNames': ['Other: Continuous Positive Airway Pressure']}], 'interventions': [{'name': 'Nasal high flow', 'type': 'OTHER', 'description': 'Newborns with respiratory distress treated with NHF.', 'armGroupLabels': ['Predicting treatment failure of Nasal High Flow in newborns']}, {'name': 'Continuous Positive Airway Pressure', 'type': 'OTHER', 'description': 'Newborns with respiratory distress treated with CPAP.', 'armGroupLabels': ['Predicting treatment failure of Continuous Positive Airway Pressure in newborns']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yerevan', 'status': 'RECRUITING', 'country': 'Armenia', 'contacts': [{'name': 'Pavel Mazmanyan, Prof', 'role': 'CONTACT', 'email': 'pavelart@gmail.com', 'phone': '+37410472340'}], 'facility': 'Erebouni Medical Centre, NICU', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}, {'city': 'Yerevan', 'status': 'NOT_YET_RECRUITING', 'country': 'Armenia', 'contacts': [{'name': 'Serine Meliksetyan, MD, PhD', 'role': 'CONTACT', 'email': 'serinemn@yahoo.com'}], 'facility': 'Republican Institute of Reproductive Health, NICU', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}, {'city': 'Yerevan', 'status': 'NOT_YET_RECRUITING', 'country': 'Armenia', 'contacts': [{'name': 'Anaida Asatryan, MD', 'role': 'CONTACT', 'email': 'asatryanan@yahoo.com'}], 'facility': 'Research Center of Maternal and Child Health Protection NICU', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}], 'centralContacts': [{'name': 'Pavel Mazmanyan, Prof', 'role': 'CONTACT', 'email': 'pavelart@gmail.com', 'phone': '+374 10 47 23 40'}, {'name': 'Ella Mirzoyan, MD', 'role': 'CONTACT', 'email': 'ellamirzoyan@gmail.com'}], 'overallOfficials': [{'name': 'Pavel Mazmanyan, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of Department of Neonatology YSMU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erebouni Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fisher and Paykel Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pavel Mazmanyan', 'investigatorAffiliation': 'Erebouni Medical Center'}}}}