Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 7:26 AM
Study NCT ID:
NCT07315594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-20
First Post:
2025-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Initial Oxygen Concentration at Birth in Late-Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Blinding will not be feasible, as each center will be assigned to each study intervention and then switch to the second intervention group. However, the trial statistician and DSMB will be blinded to group allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This will be a cluster-crossover design, unmasked randomized controlled trial (RCT) comparing two oxygen concentrations at initiation of resuscitation.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1520}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-15', 'studyFirstSubmitDate': '2025-12-18', 'studyFirstSubmitQcDate': '2025-12-18', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need for ongoing respiratory support within the 1st hour after birth', 'timeFrame': 'first 60 minutes after birth', 'description': 'Ongoing respiratory support will be defined as: the need for intubation and mechanical ventilation or the use of any non-invasive respiratory supports (e.g., CPAP, nasal high flow therapy or low flow oxygen) after initial resuscitation'}], 'secondaryOutcomes': [{'measure': 'Mortality in the delivery room', 'timeFrame': 'first 60 minutes after birth', 'description': 'Preterm infants who do not survive the resuscitation at birth'}, {'measure': 'Mortality prior discharge', 'timeFrame': 'up to 100 days after birth', 'description': 'Preterm infants who do not survive during the admission to the neonatal intensive care unit'}, {'measure': 'Duration of hospital stay', 'timeFrame': 'up to 100 days', 'description': 'duration in days the preterm infant will be admitted to the neonatal intensive care unit'}, {'measure': 'Air leak', 'timeFrame': 'first 72 hours after birth', 'description': 'Air leak defined as pneumothorax'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Birth']}, 'descriptionModule': {'briefSummary': "This study is aims to examine the best amount of oxygen to give preterm babies (born between 32 and 35 weeks) right after birth.\n\nIn the past, doctors used high levels of oxygen, but research has shown that using lower levels might help reduce the risk of death in full-term babies without harming brain development. However, investigators don't know the best oxygen level for babies born a little early (32 to 35 weeks). Some early data suggests that giving lower oxygen levels (FiO2 0.3) may not help babies reach healthy oxygen levels by 5 minutes after birth. This study will compare two oxygen levels-FiO2 0.6 and FiO2 0.3 to see which helps babies breathe better and need less ongoing breathing support. Researchers will study over 1,500 babies in hospitals across Alberta, Canada, to find the safest approach for these babies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Minutes', 'minimumAge': '0 Minutes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* i) Infants with gestational age between 32+0-35+6 weeks based on best available obstetrical estimate, requiring respiratory support\n* ii) Infants designated to receive full resuscitation, i.e., no parental request or pre-determined decision to provide only comfort care at birth\n* iii) No known major congenital or chromosomal malformation.\n\nExclusion Criteria:\n\n* i) Infant born outside of study centers and transported to centers after delivery.'}, 'identificationModule': {'nctId': 'NCT07315594', 'acronym': 'OXY-PREEM', 'briefTitle': 'Initial Oxygen Concentration at Birth in Late-Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Cluster Randomized Trial of Initial Oxygen Concentration at Birth in Late-Preterm Infants', 'orgStudyIdInfo': {'id': 'Pro00146615'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Initial use of 60% oxygen during breathing support in the delivery room', 'description': 'Infants randomized to the 60% Oxygen (FiO₂) Group will begin respiratory support with an initial inspired oxygen concentration of 60%. At birth, all infants will receive 60 seconds of delayed cord clamping as standard care. Following cord clamping, a pulse oximeter will be applied to measure peripheral oxygen saturation (SpO₂), with a reliable signal typically available at approximately 3 minutes of age.\n\nAt 3 minutes of age, the clinical team will assess SpO₂. If SpO₂ is \\<85%, the inspired oxygen concentration will be increased by 20% every 60 seconds to achieve an SpO₂ \\>85% by 5 minutes of age. If SpO₂ is \\>95% at or before 5 minutes of age, the inspired oxygen concentration will be decreased stepwise in increments of 10-20% every 60 seconds to maintain an SpO₂ \\>85% between 5 and 10 minutes of age, or an SpO₂ of 90-95% at and beyond 10 minutes of age.', 'interventionNames': ['Drug: 60% Oxygen Group - Infants will start in 60% oxygen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Initial use of 30% oxygen during breathing support in the delivery room', 'description': 'Infants randomized to the 30% Oxygen (FiO₂) Group will begin respiratory support with an initial inspired oxygen concentration of 30%. At birth, all infants will receive 60 seconds of delayed cord clamping as standard care. Following cord clamping, a pulse oximeter will be applied to measure peripheral oxygen saturation (SpO₂), with a reliable signal typically available at approximately 3 minutes of age.\n\nAt 3 minutes of age, the clinical team will assess SpO₂. If SpO₂ is \\<85%, the inspired oxygen concentration will be increased by 20% every 60 seconds to achieve an SpO₂ \\>85% by 5 minutes of age. If SpO₂ is \\>95% at or before 5 minutes of age, the inspired oxygen concentration will be decreased stepwise in increments of 10-20% every 60 seconds to maintain an SpO₂ \\>85% between 5 and 10 minutes of age, or an SpO₂ of 90-95% at and beyond 10 minutes of age.', 'interventionNames': ['Drug: 30% Oxygen Group - Infants will start in 30% oxygen']}], 'interventions': [{'name': '60% Oxygen Group - Infants will start in 60% oxygen', 'type': 'DRUG', 'otherNames': ['60% Oxygen Group'], 'description': 'Infants randomized to the 60% Oxygen (FiO₂) Group will begin respiratory support with an initial inspired oxygen concentration of 60%. At birth, all infants will receive 60 seconds of delayed cord clamping as standard care. Following cord clamping, a pulse oximeter will be applied to measure peripheral oxygen saturation (SpO₂), with a reliable signal typically available at approximately 3 minutes of age.\n\nAt 3 minutes of age, the clinical team will assess SpO₂. If SpO₂ is \\<85%, the inspired oxygen concentration will be increased by 20% every 60 seconds to achieve an SpO₂ \\>85% by 5 minutes of age. If SpO₂ is \\>95% at or before 5 minutes of age, the inspired oxygen concentration will be decreased stepwise in increments of 10-20% every 60 seconds to maintain an SpO₂ \\>85% between 5 and 10 minutes of age, or an SpO₂ of 90-95% at and beyond 10 minutes of age.', 'armGroupLabels': ['Initial use of 60% oxygen during breathing support in the delivery room']}, {'name': '30% Oxygen Group - Infants will start in 30% oxygen', 'type': 'DRUG', 'otherNames': ['30% Oxygen Group'], 'description': 'Infants randomized to the 30% Oxygen (FiO₂) Group will begin respiratory support with an initial inspired oxygen concentration of 30%. At birth, all infants will receive 60 seconds of delayed cord clamping as standard care. Following cord clamping, a pulse oximeter will be applied to measure peripheral oxygen saturation (SpO₂), with a reliable signal typically available at approximately 3 minutes of age.\n\nAt 3 minutes of age, the clinical team will assess SpO₂. If SpO₂ is \\<85%, the inspired oxygen concentration will be increased by 20% every 60 seconds to achieve an SpO₂ \\>85% by 5 minutes of age. If SpO₂ is \\>95% at or before 5 minutes of age, the inspired oxygen concentration will be decreased stepwise in increments of 10-20% every 60 seconds to maintain an SpO₂ \\>85% between 5 and 10 minutes of age, or an SpO₂ of 90-95% at and beyond 10 minutes of age.', 'armGroupLabels': ['Initial use of 30% oxygen during breathing support in the delivery room']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T5H 3V9', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'contacts': [{'name': 'Georg SCHMOLZER', 'role': 'CONTACT', 'email': 'georg.schmoelzer@me.com', 'phone': '7807354647'}, {'name': 'Caroline Fray', 'role': 'CONTACT', 'email': 'caroline.fray@albertahealthservices.ca', 'phone': '7807354647'}, {'name': 'Georg Schmolzer', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Caroline Fray', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Brenda Law', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Royal Alexandra Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'centralContacts': [{'name': 'Caroline Fray', 'role': 'CONTACT', 'email': 'caroline.fray@albertahealthservices.ca', 'phone': '7807354647'}], 'overallOfficials': [{'name': 'Georg Schmolzer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'The Study Protocol and the Statistical Analysis Plan (SAP) will be published during the recruitment phase of the trial.\n\nInformed Consent Form (ICF) and Clinical Study Report (CSR) can be requested from Prof. Georg Schmolzer via schmolze@ualberta.ca', 'ipdSharing': 'YES', 'description': 'there is no current plan, however requests can be send to Prof. Georg Schmolzer via schmolze@ualberta.ca.', 'accessCriteria': 'Requests can be send to Prof. Georg Schmolzer via schmolze@ualberta.ca'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}