Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:48 AM
Study NCT ID:
NCT07418502
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pressure Targeting During High Flow Therapy in Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001261', 'term': 'Pulmonary Atelectasis'}, {'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Failure of Support', 'timeFrame': '24 hours', 'description': 'Failure of respiratory support as defined by increase in fraction of inspired oxygen (FiO2) of ≥0.10, a pH of ≤7.2 with a CO2 ≥60 mm Hg, an increase in transcutaneous CO2 of ≥15mmHg above baseline or ≥2 episodes of apnea requiring positive-pressure ventilation'}], 'secondaryOutcomes': [{'measure': 'Oxygenation', 'timeFrame': '24 hours', 'description': 'ratio of mean SpO2 to FiO2'}, {'measure': 'Respiratory Rate', 'timeFrame': '24 hours', 'description': 'Mean respiratory rate'}, {'measure': 'Infant comfort - NIPE', 'timeFrame': '24 hours', 'description': 'Newborn Infant Parasympathetic Evaluation'}, {'measure': 'Infant Comfort - Parent', 'timeFrame': '24 hours', 'description': 'Parental Questionnaire'}, {'measure': 'Resource Use', 'timeFrame': '24 hours', 'description': 'Number of handling/repositioning episodes by nurse/respiratory therapist'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preterm', 'CPAP', 'High Flow'], 'conditions': ['Preterm Infants', 'Respiratory Distress Syndrome (Neonatal)', 'BPD - Bronchopulmonary Dysplasia']}, 'descriptionModule': {'briefSummary': "The goal of this study is to see if a new approach to breathing support ('Pressure Targeted High Flow') is as effective as standard of care ('Continuous Positive Airway Pressure') in prematurely born infants. It will also learn about the effect of these types of breathing support on infant comfort and impact on staffing. The main question it aims to answer is:\n\nDoes Pressure Targeted High Flow provide enough support in premature infants?\n\nParticipants will:\n\nTake spend 24 hours supported by Pressure Targeted High Flow and 24 hours supported by CPAP. During this time their breathing rate, oxygen requirement and other markers of comfort will be monitored."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '40 Weeks', 'minimumAge': '7 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Delivery at \\>24+0 weeks and ≤32+6 weeks of gestation\n* Postnatal age \\>7 days but \\< 6 weeks old\n* Weight ≥1,000grams at the time of study\n* Receiving clinically prescribed CPAP at pressures of 5-8cm H2O\n* Requiring an FiO2 of ≤0.60\n\nExclusion Criteria:\n\n* Chromosomal disorder (aneuploidy)\n* Presence of major congenital birth defect including airway anomalies, congenital diaphragmatic hernia or cardiac defects (other than patent foramen ovale and patent ductus arteriosus)\n* Prior pneumothorax\n* Infants in whom chance of survival is uncertain'}, 'identificationModule': {'nctId': 'NCT07418502', 'acronym': 'NeoMATCH', 'briefTitle': 'Pressure Targeting During High Flow Therapy in Premature Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'A Phase 2 Crossover Trial of Pressure Targeted High Flow Therapy in Premature Infants', 'orgStudyIdInfo': {'id': 'FP00010928'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PTHF First', 'description': 'PTHF prior to CPAP', 'interventionNames': ['Procedure: Pressure Targeted High Flow']}, {'type': 'OTHER', 'label': 'CPAP First', 'description': 'CPAP prior to PTHF', 'interventionNames': ['Procedure: CPAP']}], 'interventions': [{'name': 'Pressure Targeted High Flow', 'type': 'PROCEDURE', 'description': 'High Flow Nasal Cannula therapy with Pressure monitoring to match delivered CPAP pressure', 'armGroupLabels': ['PTHF First']}, {'name': 'CPAP', 'type': 'PROCEDURE', 'description': 'Standard of care CPAP therapy', 'armGroupLabels': ['CPAP First']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Anup Katheria', 'role': 'CONTACT', 'email': 'anup.katheria@sharp.com', 'phone': '858-939-3400'}], 'facility': 'Sharp Mary Birch Hospital for Women & Newborns', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Alan Groves', 'role': 'CONTACT', 'email': 'alan.groves@austin.utexas.edu', 'phone': '512 324 1085'}], 'facility': 'Ascension Seton Medical Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'centralContacts': [{'name': 'Alan Groves', 'role': 'CONTACT', 'email': 'alan.groves@austin.utexas.edu', 'phone': '512 324 1085'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Happy to share IPD if a need arises'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sharp Mary Birch Hospital for Women & Newborns', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Alan Groves', 'investigatorAffiliation': 'University of Texas at Austin'}}}}