Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 12:41 AM
Study NCT ID:
NCT04477460
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2020-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057768', 'term': 'Brief, Resolved, Unexplained Event'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D003490', 'term': 'Cyanosis'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2020-07-15', 'studyFirstSubmitQcDate': '2020-07-15', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of persistent symptoms and repeat hospitalizations over 6-month follow-up period', 'timeFrame': '6 months', 'description': 'Frequency of persistent symptoms and repeat hospitalizations over the 6 months after enrollment, with a comparison between those receiving and not receiving thickened feeds.'}], 'secondaryOutcomes': [{'measure': 'Frequency of persistent symptoms and hospitalization risk over the full 12-month follow-up period', 'timeFrame': '12 months', 'description': "Symptoms and hospitalization risk over the full 12-month follow-up period, optimal period of time needed for thickening, parent-reported anxiety levels, cost of care at Boston Children's Hospital, potential adverse effects of thickening, and urine arsenic levels, all compared between subjects receiving and not receiving thickened feeds."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brief Resolved Unexplained Event', 'Apparent Life Threatening Event', 'Oropharyngeal Dysphagia']}, 'referencesModule': {'references': [{'pmid': '31103259', 'type': 'BACKGROUND', 'citation': 'Duncan DR, Growdon AS, Liu E, Larson K, Gonzalez M, Norris K, Rosen RL. The Impact of the American Academy of Pediatrics Brief Resolved Unexplained Event Guidelines on Gastrointestinal Testing and Prescribing Practices. J Pediatr. 2019 Aug;211:112-119.e4. doi: 10.1016/j.jpeds.2019.04.007. Epub 2019 May 15.'}, {'pmid': '27741062', 'type': 'BACKGROUND', 'citation': 'Duncan DR, Amirault J, Mitchell PD, Larson K, Rosen RL. Oropharyngeal Dysphagia Is Strongly Correlated With Apparent Life-Threatening Events. J Pediatr Gastroenterol Nutr. 2017 Aug;65(2):168-172. doi: 10.1097/MPG.0000000000001439.'}, {'pmid': '36336644', 'type': 'BACKGROUND', 'citation': 'Duncan DR, Liu E, Growdon AS, Larson K, Rosen RL. A Prospective Study of Brief Resolved Unexplained Events: Risk Factors for Persistent Symptoms. Hosp Pediatr. 2022 Dec 1;12(12):1030-1043. doi: 10.1542/hpeds.2022-006550.'}]}, 'descriptionModule': {'briefSummary': 'This observational study will examine the effects of thickened feeds on clinical outcomes and healthcare utilization in infants with brief resolved unexplained event (BRUE).', 'detailedDescription': 'Brief resolved unexplained events (BRUE) are frightening episodes characterized by the appearance of life-threatening choking, pallor, cyanosis, and limpness in infants. These common events are resource-intensive and current management approaches inadequately address persistent symptoms. Infants with BRUE commonly have oropharyngeal dysphagia with aspiration, which is a modifiable risk factor for persistent symptoms, but there are no studies determining the mechanism behind this swallowing dysfunction and if swallowing interventions reduce morbidity. This is a prospective, longitudinal cohort study of infants who experienced brief resolved unexplained event receiving thickened feedings compared to those not receiving thickened feedings over 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '0 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Participants will be eligible for the study if they are less than 1 year of age and admitted to Boston Children's Hospital after experiencing first lifetime BRUE", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Less than 1 year of age\n* Admitted to Boston Children's Hospital after experiencing first lifetime brief resolved unexplained event.\n\nExclusion Criteria:\n\n* Any pre-existing medical diagnoses that exclude brief resolved unexplained event diagnosis including seizure disorders and cyanotic congenital heart disease\n* Already receiving thickened liquids for treatment of another condition"}, 'identificationModule': {'nctId': 'NCT04477460', 'acronym': 'BRUE', 'briefTitle': 'Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event', 'orgStudyIdInfo': {'id': 'IRB-P00038785'}, 'secondaryIdInfos': [{'id': 'K23DK127251', 'link': 'https://reporter.nih.gov/quickSearch/K23DK127251', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infants with BRUE receiving thickened feeds', 'interventionNames': ['Dietary Supplement: Thickened feeds']}, {'label': 'Infants with BRUE not receiving thickened feeds', 'interventionNames': ['Dietary Supplement: Non-thickened feeds']}], 'interventions': [{'name': 'Thickened feeds', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Thickened feeds directed by medical team', 'armGroupLabels': ['Infants with BRUE receiving thickened feeds']}, {'name': 'Non-thickened feeds', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Non-thickened feeds directed by medical team', 'armGroupLabels': ['Infants with BRUE not receiving thickened feeds']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel R Duncan, MD, MPH', 'role': 'CONTACT', 'email': 'daniel.duncan@childrens.harvard.edu', 'phone': '6173550897'}], 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Daniel R Duncan, MD, MPH', 'role': 'CONTACT', 'email': 'daniel.duncan@childrens.harvard.edu', 'phone': '6173550897'}], 'overallOfficials': [{'name': 'Daniel R Duncan, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}, {'name': 'Rachel Rosen, MD, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': "Boston Children's Hospital"}, {'name': 'Sudarshan Jadcherla, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Nationwide Children's Hospital"}, {'name': 'Taher Omari, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Flinders University'}, {'name': 'Samuel Nurko, MD, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': "Boston Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Daniel Duncan', 'investigatorAffiliation': "Boston Children's Hospital"}}}}