Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2026-03-09 @ 4:05 AM
Study NCT ID:
NCT06622902
Status:
RECRUITING
Last Update Posted:
2025-11-28
First Post:
2024-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2024-06-26', 'studyFirstSubmitQcDate': '2024-10-01', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delta CO2', 'timeFrame': '3 hours after flow change', 'description': 'the change in TcCO2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Respiratory distress syndrome', 'prematurity', 'HIGH FLOW', 'CO2', 'VENTILATION'], 'conditions': ['Respiratory Distress Syndrome', 'Prematurity', 'Non Invasive Ventilation']}, 'descriptionModule': {'briefSummary': "Background Preterm infants often need respiratory support. HFNV is a non-invasive method with benefits over CPAP, such as reduced nasal trauma and improved feeding.\n\nAim Study the impact of low (2 LPM) vs. high (6 LPM) HFNV flow rates on CO2 levels in preterm infants.\n\nMethods Design: Prospective, crossover observational study. Participants: Preterm newborns (24-33.6 weeks' gestation) on HFNV. Procedure: Randomized flow rate adjustments, monitoring tcCO2 and other respiratory parameters over three hours.\n\nOutcomes Primary: Change in tcCO2. Secondary: Study terminations due to unsafe CO2 levels and changes in other respiratory metrics.\n\nStatistical Analysis Sample size: 45 infants. Analysis: Paired and unpaired t-tests for comparison within and between groups.", 'detailedDescription': "Background:\n\nPreterm Births: About 10% of births are preterm, with infants at risk for respiratory distress.\n\nRespiratory Support: Endotracheal ventilation has improved survival but increased the risk of bronchopulmonary dysplasia.\n\nNon-Invasive Support: Nasal CPAP minimizes complications. Heated, humidified high-flow nasal ventilation (HFNV) is an alternative, providing advantages like reduced nasal trauma and improved oral feeding.\n\nAim:\n\nPrimary Goal: Examine changes in transcutaneous CO2 (tcCO2) levels in preterm infants when using HFNV at low (2 LPM) versus high (6 LPM) flow rates.\n\nHypothesis: Different HFNV flow rates will show minimal change in tcCO2 (≤5 mmHg).\n\nMethods:\n\nDesign: Prospective, crossover observational study in Rambam NICU. Participants: Preterm newborns (24-33.6 weeks' gestation) needing HFNV. Inclusion Criteria: Stabilized HFNP settings and tcCO2, parental consent. Exclusion Criteria: Specific flow and CO2 levels, unstable conditions, or congenital malformations.\n\nProcedure: Randomize infants into two groups starting with 2 or 6 LPM flow rates, monitoring tcCO2 over three consecutive hours with alternating flow rates.\n\nMeasurements:\n\nPrimary Outcome: Change in tcCO2 levels. Secondary Outcomes: Number of study terminations due to pCO2/TcCO2 out of safety range, changes in respiratory parameters, and episodes of desaturation or bradycardia.\n\nStatistical Analysis:\n\nSample Size: 45 infants needed to detect no difference with 90% power and 5% significance level.\n\nData Analysis: Use paired and unpaired Student's t-tests to compare results within and between groups.\n\nSafety Protocol: The study will terminate if significant desaturation, bradycardia, or pCO2 levels outside the safety range occur."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Gestational age 240 to 336.\n* At least 6 hours of stabilized HFNP settings, i.e. minor changes in settings (FiO2 ≤0.10, no change in flow).\n* At least 6 hours of stabilized tcCO2, i.e. ≤5 mmHg variation.\n* At least 6 hours from surfactant administration.\n* Parental consent\n\nExclusion criteria:\n\n* If flow is \\<3 and tcCO2 related pCO2 is\\<40mmHg.\n* If Flow is ≥5 bpm and tcCO2 related pCO2 is\\>60mmHg.\n* Unstable infants due to acute conditions (sepsis. IVH), or congenital malformations.'}, 'identificationModule': {'nctId': 'NCT06622902', 'briefTitle': 'Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Influence of Flow Rate Change on CO2 Levels During High Flow Nasal Ventilation (HFNV) in Preterm Infants.', 'orgStudyIdInfo': {'id': 'RMB059422'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'start with 2LPM', 'description': 'start with 2LPM', 'interventionNames': ['Other: change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours', 'Other: change flow from 2 to 6 LPM. Follow TcCO2 for 3h']}, {'type': 'EXPERIMENTAL', 'label': 'start with 6LPM0', 'description': 'start with 6LPM', 'interventionNames': ['Other: change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours', 'Other: change flow from 2 to 6 LPM. Follow TcCO2 for 3h']}], 'interventions': [{'name': 'change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours', 'type': 'OTHER', 'description': 'change flow from 6 to 2 LPM. Follow TcCO2 for 3 hours', 'armGroupLabels': ['start with 2LPM', 'start with 6LPM0']}, {'name': 'change flow from 2 to 6 LPM. Follow TcCO2 for 3h', 'type': 'OTHER', 'description': 'change flow from 2 to 6 LPM. Follow TcCO2 for 3h', 'armGroupLabels': ['start with 2LPM', 'start with 6LPM0']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ori Hochwald, MD', 'role': 'CONTACT', 'email': 'o_hochwald@rambam.health.gov.il', 'phone': '972-4-7774111'}], 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Ori Hochwald, MD', 'role': 'CONTACT', 'email': 'ORI.HOCHWALD@GMAIL.COM', 'phone': '972502062110'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, NICU', 'investigatorFullName': 'Ori Hochwald , MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}