Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:13 PM
Study NCT ID:
NCT04890158
Status:
TERMINATED
Last Update Posted:
2024-09-05
First Post:
2021-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Prone Versus Supine Positioning and the Impact on Bronchopulmonary Dysplasia in Very Low Birth Weight Infants.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}], 'ancestors': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016684', 'term': 'Prone Position'}], 'ancestors': [{'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alethomp@montefiore.org', 'phone': '718-904-4105', 'title': 'Dr. Alecia Thompson-Branch', 'organization': 'Montefiore Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Collected until the infant reaches 36 weeks preconceptional age or is discharged from the NICU, or is on 21% FiO2 (i.e., room air) without any respiratory interface, whichever is earlier.', 'description': "There was no enrollment into the 'Usual Positioning' arm of the study.", 'eventGroups': [{'id': 'EG000', 'title': 'Prone Positioning for a Total of 6 Hours Daily by Study Protocol', 'description': 'Patients will be positioned prone for 3 hours then placed supine for 3 hours then prone again for 3 additional hours. The change in position from prone to supine and back is to more reliably document possible changes in ventilation, oxygenation, other vital signs and respiratory support required.\n\nProne positioning for a total of 6 hours daily: Prone positioning for 6 hours daily', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Positioning', 'description': 'Patients in the newborn intensive care unit are physically handled usually every 3-4 hours. Those study participants who are randomly assigned to "usual position" may rest in a variety of positions in any order based on nursing or perceived patient preference. Positions may include supine, right lateral, left lateral, and prone as well.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Moderate (Grade 2) or Severe (Grade 3) Bronchopulmonary Dysplasia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prone Positioning for a Total of 6 Hours Daily by Study Protocol', 'description': 'Patients will be positioned prone for 3 hours then placed supine for 3 hours then prone again for 3 additional hours. The change in position from prone to supine and back is to more reliably document possible changes in ventilation, oxygenation, other vital signs and respiratory support required.\n\nProne positioning for a total of 6 hours daily: Prone positioning for 6 hours daily'}, {'id': 'OG001', 'title': 'Usual Positioning', 'description': 'Patients in the newborn intensive care unit are physically handled usually every 3-4 hours. Those study participants who are randomly assigned to "usual position" may rest in a variety of positions in any order based on nursing or perceived patient preference. Positions may include supine, right lateral, left lateral, and prone as well.'}], 'timeFrame': 'as determined by respiratory support requirements at 36 weeks postconceptional age', 'description': 'The number of infants with either Moderate or Severe Bronchopulmonary Dysplasia (BPD) will be determined per study arm. Moderate and Severe BPD will be defined as follows:\n\nModerate (Grade 2) BPD: If an infant requires nCPAP, NIPPV, HFNC, or NC \\> 2 liters per minute flow and receiving \\> 21% FiO2.\n\nSevere (Grade 3) BPD: If an infant requires invasive positive pressure ventilation via an endotracheal or tracheostomy irrespective of the amount of FiO2.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated early and Primary Outcome Measure data was not collected and/or analyzed for this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prone Positioning for a Total of 6 Hours Daily by Study Protocol', 'description': 'Patients will be positioned prone for 3 hours then placed supine for 3 hours then prone again for 3 additional hours. The change in position from prone to supine and back is to more reliably document possible changes in ventilation, oxygenation, other vital signs and respiratory support required.\n\nProne positioning for a total of 6 hours daily: Prone positioning for 6 hours daily'}, {'id': 'FG001', 'title': 'Usual Positioning', 'description': 'Patients in the newborn intensive care unit are physically handled usually every 3-4 hours. Those study participants who are randomly assigned to "usual position" may rest in a variety of positions in any order based on nursing or perceived patient preference. Positions may include supine, right lateral, left lateral, and prone as well.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Prone Positioning for a Total of 6 Hours Daily by Study Protocol', 'description': 'Patients will be positioned prone for 3 hours then placed supine for 3 hours then prone again for 3 additional hours. The change in position from prone to supine and back is to more reliably document possible changes in ventilation, oxygenation, other vital signs and respiratory support required.\n\nProne positioning for a total of 6 hours daily: Prone positioning for 6 hours daily'}, {'id': 'BG001', 'title': 'Usual Positioning', 'description': 'Patients in the newborn intensive care unit are physically handled usually every 3-4 hours. Those study participants who are randomly assigned to "usual position" may rest in a variety of positions in any order based on nursing or perceived patient preference. Positions may include supine, right lateral, left lateral, and prone as well.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Approximately 27 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Only 1 infant was enrolled (gestational age \\~27 weeks), into the Prone Positioning Arm, due to early termination of the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-27', 'size': 2884488, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-27T11:33', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'A list of study participants identified only study number, will be provided to a blinded outcomes assessor at 36 weeks post conceptional age. The respiratory support parameters of study participants will determine the primary outcome of moderate (Grade 2) or severe (Grade 3) BPD.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Protocol review had expired and the study had previously been Suspended. There was no funding to continue the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-30', 'studyFirstSubmitDate': '2021-05-12', 'resultsFirstSubmitDate': '2024-03-27', 'studyFirstSubmitQcDate': '2021-05-12', 'lastUpdatePostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-30', 'studyFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Moderate (Grade 2) or Severe (Grade 3) Bronchopulmonary Dysplasia', 'timeFrame': 'as determined by respiratory support requirements at 36 weeks postconceptional age', 'description': 'The number of infants with either Moderate or Severe Bronchopulmonary Dysplasia (BPD) will be determined per study arm. Moderate and Severe BPD will be defined as follows:\n\nModerate (Grade 2) BPD: If an infant requires nCPAP, NIPPV, HFNC, or NC \\> 2 liters per minute flow and receiving \\> 21% FiO2.\n\nSevere (Grade 3) BPD: If an infant requires invasive positive pressure ventilation via an endotracheal or tracheostomy irrespective of the amount of FiO2.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prone positioning', 'bronchopulmonary dysplasia'], 'conditions': ['Prone Positioning', 'Bronchopulmonary Dysplasia']}, 'descriptionModule': {'briefSummary': 'In this pilot study, the investigator team aims to evaluate whether standardized prone positioning compared to usual positioning improves moderate to severe bronchopulmonary dysplasia (BPD) rates as assessed at 36 weeks post conceptional age in very low birth weight preterm infants with bronchopulmonary dysplasia.', 'detailedDescription': 'The investigator team aims to enroll and randomize infants born at less than 1500 grams at birth, who remain on positive pressure support for at least 7 days after birth AND/OR on any other respiratory device such as nasal cannula with flow rates greater than 2 liters per minute (LPM) receiving supplemental oxygen of greater than 21% for at least 7 days after birth.\n\nPatients whose families consent to participation will be assigned via block randomization to\n\n1. usual care in which positioning and duration in each position is random per usual nursing routine OR\n2. Receive standardized scheduled daily prone positioning starting on day of life 7.\n\nAs part of normal developmental care, most infants are evaluated and have care rendered (touch-time), if stable, and repositioned at set three-hour intervals to permit uninterrupted sleep and/or rest. The hands-off interval will be maintained throughout the study interval. Infants randomized to the standardized scheduled daily prone positioning will be placed in prone body position for a total of 6 hours daily, that is prone position for 3 hours, followed by supine positioning for 3 hrs, then placed in prone position for another 3-hour interval. Both infants randomized to standardized prone positioning and usual positioning will have a bedside card identifying that the infant is a study participant and will serve as a way to document the number of times any infant enrolled in the study is placed in prone positioning even if not randomized to standardized prone positioning.\n\nStandardized daily positioning will occur for randomized patients until 36 weeks or discharge whichever is first. The primary outcome of moderate or severe BPD will be assigned by blinded study personnel based on respiratory support parameters on the day the infant is 36 weeks postconceptional age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Weeks', 'minimumAge': '7 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infants born at less than 1500 grams at birth, who remain on positive pressure support for at least 7 days after birth AND/OR on any other respiratory device such as nasal cannula with flow rates greater than 2LPM receiving supplemental oxygen of greater than 21% for at least 7 days after birth. Positive pressure for the purposes of this study is defined as nasal cannula delivering a flow of 2 LPM or higher, continuous positive airway pressure (CPAP), non-invasive positive pressure ventilation or non-invasive mechanical ventilation (NIPPV/NIMV), as well infants who are intubated or have a tracheostomy for oxygenation and ventilation related to their lung disease, irrespective of the mode of ventilation.\n\nExclusion Criteria:\n\n* infants who were previously on room air without a respiratory device who were intubated for the purposes of surgery and were not receiving respiratory support as defined above prior, those intubated for other airway issues such as tracheal stenosis, broncheo- or tracheomalacia, etc and not for the management of BPD. Additional patients to be excluded include those with suspected or proven genetic or other major congenital anomalies that may impact cardiac and lung function including cardiac and lung anomalies, as well as those at the time of enrollment who require surgeries that will impact their ability to be placed in prone positioning (eg gastroschisis, omphalocele, etc).'}, 'identificationModule': {'nctId': 'NCT04890158', 'briefTitle': 'Prone Versus Supine Positioning and the Impact on Bronchopulmonary Dysplasia in Very Low Birth Weight Infants.', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Standardized Prone Positioning Compared to Usual Positioning of Very Low Birth Weight Infants Receiving Respiratory Support and the Effect on Bronchopulmonary Dysplasia', 'orgStudyIdInfo': {'id': '2021-13059'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prone positioning for a total of 6 hours daily by study protocol', 'description': 'Patients will be positioned prone for 3 hours then placed supine for 3 hours then prone again for 3 additional hours. The change in position from prone to supine and back is to more reliably document possible changes in ventilation, oxygenation, other vital signs and respiratory support required.', 'interventionNames': ['Other: Prone positioning for a total of 6 hours daily']}, {'type': 'NO_INTERVENTION', 'label': 'usual positioning', 'description': 'Patients in the newborn intensive care unit are physically handled usually every 3-4 hours. Those study participants who are randomly assigned to "usual position" may rest in a variety of positions in any order based on nursing or perceived patient preference. Positions may include supine, right lateral, left lateral, and prone as well.'}], 'interventions': [{'name': 'Prone positioning for a total of 6 hours daily', 'type': 'OTHER', 'description': 'Prone positioning for 6 hours daily', 'armGroupLabels': ['Prone positioning for a total of 6 hours daily by study protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Alecia Thompson-Branch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}