Raw JSON
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'SECONDARY', 'title': 'Number of Participants With Emesis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nasogastric Tube (NGT) Feeding', 'description': 'Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.'}, {'id': 'OG001', 'title': 'Nasoduodenal Tube (NDT) Feeding', 'description': 'Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from the time of hospital admission to discharge (about 6 days)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Respiratory Support in Liters Per Minute', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nasogastric Tube (NGT) Feeding', 'description': 'Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.'}, {'id': 'OG001', 'title': 'Nasoduodenal Tube (NDT) Feeding', 'description': 'Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from the time of hospital admission to discharge (about 6 days)', 'unitOfMeasure': 'liters per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Chest X-rays Obtained Among All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 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from the nose to the stomach.'}, {'id': 'OG001', 'title': 'Nasoduodenal Tube (NDT) Feeding', 'description': 'Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days after discharge from hospital', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 in the NGT arm were lost to follow up, and 3 in the NDT arm were lost to follow up; therefore, this data was not collected for these participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Were Readmitted to the Hospital', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nasogastric Tube (NGT) Feeding', 'description': 'Nasogastric tube (NGT) feeding: A 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'Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.'}, {'id': 'OG001', 'title': 'Nasoduodenal Tube (NDT) Feeding', 'description': 'Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days after discharge from initial hospital visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 in the NGT arm were lost to follow up, and 3 in the NDT arm were lost to follow up; therefore, this data was not collected for these 5 participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nasogastric Tube (NGT) Feeding', 'description': 'Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.'}, {'id': 'FG001', 'title': 'Nasoduodenal Tube (NDT) Feeding', 'description': 'Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nasogastric Tube (NGT) Feeding', 'description': 'Nasogastric tube (NGT) feeding: A nasogastric tube goes from the nose to the stomach.'}, {'id': 'BG001', 'title': 'Nasoduodenal Tube (NDT) Feeding', 'description': 'Nasoduodenal tube (NDT) feeding: A nasoduodenal tube goes from the nose to the duodenum.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '165', 'spread': '102', 'groupId': 'BG000'}, {'value': '132', 'spread': '101', 'groupId': 'BG001'}, {'value': '148.5', 'spread': '101.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '6.1', 'spread': '2', 'groupId': 'BG001'}, {'value': '6.45', 'spread': '2.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Participants with Term Gestation', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants with Preterm Gestation', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants with spontaneous vaginal delivery (SVD)', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants with cesarean delivery (CD)', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants with low risk of aspiration', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants with high risk of aspiration', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-26', 'size': 847234, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-06T13:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'whyStopped': 'Loss of equipoise among enrolling clinicians, as well as emergence of external literature showing safety of nasogastric tube (NGT) feeds.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2017-11-14', 'resultsFirstSubmitDate': '2020-03-09', 'studyFirstSubmitQcDate': '2017-11-16', 'lastUpdatePostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-09', 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of Respiratory Supprt', 'timeFrame': 'from the time of hospital admission to discharge (about 6 days)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Emesis', 'timeFrame': 'from the time of hospital admission to discharge (about 6 days)'}, {'measure': 'Peak Respiratory Support in Liters Per Minute', 'timeFrame': 'from the time of hospital admission to discharge (about 6 days)'}, {'measure': 'Number of Chest X-rays Obtained Among All Participants', 'timeFrame': 'from the time of hospital admission to discharge (about 6 days)'}, {'measure': 'Number of Participants Who Revisited the Emergency Room (ER)', 'timeFrame': '7 days after discharge from hospital'}, {'measure': 'Number of Participants Who Revisited the Emergency Room (ER)', 'timeFrame': '30 days after discharge from hospital'}, {'measure': 'Number of Participants Who Were Readmitted to the Hospital', 'timeFrame': '7 days after discharge from initial hospital visit'}, {'measure': 'Number of Participants Who Were Readmitted to the Hospital', 'timeFrame': '30 days after discharge from initial hospital visit'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Enteral Feeding in Bronchiolitis']}, 'referencesModule': {'references': [{'pmid': '31061025', 'type': 'DERIVED', 'citation': 'Parlar-Chun R, Lafferty-Prather M, Gonzalez V, Pedroza C, Gourishankar A. Protocol: randomised trial to compare nasoduodenal tube and nasogastric tube feeding in infants with bronchiolitis on high-flow nasal cannula; Bronchiolitis and High-flow nasal cannula with Enteral Tube feeding Randomised (BHETR) trial. BMJ Open. 2019 May 5;9(5):e025405. doi: 10.1136/bmjopen-2018-025405.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare two ways (nasogastric tube (NGT) and nasoduodenal tube (NDT)) to provide nutrition to infants admitted to the hospital for viral bronchiolitis and who require high flow nasal cannula therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- All admitted patients for bronchiolitis requiring high flow nasal cannula therapy at Children's Memorial Hermann\n\nExclusion Criteria:\n\n* Patients with craniofacial abnormalities that prevent tube placement.\n* Patients requiring CPAP and mechanical ventilation are also excluded from the study.\n* Patients with past surgeries compromising esophageal sphincter tone such as fundoplication or congenital diaphragmatic hernia surgery are excluded.\n* Patients transferred to and from PICU are also excluded from the study."}, 'identificationModule': {'nctId': 'NCT03346850', 'briefTitle': 'Comparison Between Gastric and Post Pyloric Tube Feedings in Children With Bronchiolitis Requiring High Flow Nasal Cannula', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Comparison Between Gastric and Post Pyloric Tube Feedings in Children With Bronchiolitis Requiring High Flow Nasal Cannula', 'orgStudyIdInfo': {'id': 'HSC-MS-17-0725'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'nasogastric tube (NGT) feeding', 'interventionNames': ['Device: Nasogastric tube (NGT) feeding']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'nasoduodenal tube (NDT) feeding', 'interventionNames': ['Device: Nasoduodenal tube (NDT) feeding']}], 'interventions': [{'name': 'Nasogastric tube (NGT) feeding', 'type': 'DEVICE', 'description': 'A nasogastric tube goes from the nose to the stomach.', 'armGroupLabels': ['nasogastric tube (NGT) feeding']}, {'name': 'Nasoduodenal tube (NDT) feeding', 'type': 'DEVICE', 'description': 'A nasoduodenal tube goes from the nose to the duodenum.', 'armGroupLabels': ['nasoduodenal tube (NDT) feeding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Raymond Parlar-Chun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Raymond Parlar-Chun', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}