Ignite Creation Date:
2025-12-24 @ 11:55 AM
Ignite Modification Date:
2026-05-27 @ 11:00 AM
Study NCT ID:
NCT03853161
Status:
UNKNOWN
Last Update Posted:
2021-02-09
First Post:
2019-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Flow Nasal Cannula Versus Nasal Intermittent Positive Pressure (NIPPV) in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-07', 'studyFirstSubmitDate': '2019-02-19', 'studyFirstSubmitQcDate': '2019-02-22', 'lastUpdatePostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of intubation within 7 days of starting the study treatment', 'timeFrame': 'one week', 'description': 'Failure of non invasive support by criteria of pH, blood carbon dioxide level, oxygen requirements or apneas'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Infant']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the effectiveness of Heated Humidified High Flow Nasal Cannula (HHHFNC) versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) in preventing intubation when used as primary respiratory support for Respiratory Distress Syndrome (RDS) or post extubation in preterm infants', 'detailedDescription': 'Patient population will include preterm infants born at 24 - 36+6 weeks of gestation who are candidates for non-invasive respiratory support post extubation or as primary respiratory support after birth. They will be will be randomized to 2 groups: Heated Humidified High Flow Nasal Cannula (HHHFNC) and Nasal Intermittent Positive Pressure Ventilation (NIPPV).\n\nThis will be a prospective unblinded randomized controlled study, designed as a non-inferiority trial.\n\nPrimary outcome: The primary outcome will be rate of treatment failure (need for intubation) within 7 days of starting the study treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants born at 24-27+6 weeks of gestation and up to 28 days of life who are extubated for the first time after birth or immediately after surfactant administration via (intubation-surfactant-extubation) INSURE or (minimally invasive surfactant therapy) MIST procedures.\n* Infants born at 28-36+6 weeks of gestation and up to 28 days of life who are candidates for non-invasive support either as a primary modality after birth or post extubation.\n* Signed parental informed consent by one of the parents\n\nExclusion Criteria:\n\n* Infants who are unlikely to survive the immediate postnatal period or who have significant congenital abnormalities\n* Presence of a pneumothorax prior to enrollment\n* Hemodynamic instability due to sepsis or hemorrhage\n* Inability to obtain parental consent\n* Shortage of suitable equipment\n* Infants who were intubated solely for surgery'}, 'identificationModule': {'nctId': 'NCT03853161', 'acronym': 'VAPORAM', 'briefTitle': 'High Flow Nasal Cannula Versus Nasal Intermittent Positive Pressure (NIPPV) in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Carmel Medical Center'}, 'officialTitle': 'A Multicenter Randomized Controlled Trial Comparing High Flow Nasal Cannula and NIPPV in Preterm Infants', 'orgStudyIdInfo': {'id': 'CMC-17-0131-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vapotherm arm', 'description': 'Preterm infants in this arm will be given respiratory support of heated humidified high flow via Precision Flow Vapotherm, Exeter, USA', 'interventionNames': ['Other: Vapotherm']}, {'type': 'EXPERIMENTAL', 'label': 'NIPPV arm', 'description': 'Preterm infants in this arm will be given respiratory support of Nasal Intermittent Positive Pressure Ventilation via the Leoni Plus neonatal ventilator', 'interventionNames': ['Other: NIPPV']}], 'interventions': [{'name': 'Vapotherm', 'type': 'OTHER', 'otherNames': ['Heated Humidified High Flow Nasal Cannula'], 'description': 'A form of non invasive ventilation used in newborns', 'armGroupLabels': ['Vapotherm arm']}, {'name': 'NIPPV', 'type': 'OTHER', 'otherNames': ['Nasal Intermittent Positive Pressure Ventilation'], 'description': 'A form of non invasive ventilation used in newborns', 'armGroupLabels': ['NIPPV arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ayala Gover, MD', 'role': 'CONTACT', 'email': 'ayalagover@gmail.com', 'phone': '972-52-396948'}], 'facility': 'Carmel Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Ayala Gover, MD', 'role': 'CONTACT', 'email': 'ayalagover@gmail.com', 'phone': '972-528-396948'}], 'overallOfficials': [{'name': 'Ayala Gover, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carmel Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Ayala Gover', 'investigatorAffiliation': 'Carmel Medical Center'}}}}