<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04477460</url>
  </required_header>
  <id_info>
    <org_study_id>ObservationalBRUE</org_study_id>
    <secondary_id>K23DK127251</secondary_id>
    <nct_id>NCT04477460</nct_id>
  </id_info>
  <brief_title>Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event</brief_title>
  <acronym>BRUE</acronym>
  <official_title>Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This observational study will examine the effects of thickened feeds on clinical outcomes and&#xD;
      healthcare utilization in infants with brief resolved unexplained event (BRUE).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Brief resolved unexplained events (BRUE) are frightening episodes characterized by the&#xD;
      appearance of life-threatening choking, pallor, cyanosis, and limpness in infants. These&#xD;
      common events are resource-intensive and current management approaches inadequately address&#xD;
      persistent symptoms. Infants with BRUE commonly have oropharyngeal dysphagia with aspiration,&#xD;
      which is a modifiable risk factor for persistent symptoms, but there are no studies&#xD;
      determining the mechanism behind this swallowing dysfunction and if swallowing interventions&#xD;
      reduce morbidity. This is a prospective, longitudinal cohort study of infants who experienced&#xD;
      brief resolved unexplained event receiving thickened feedings compared to those not receiving&#xD;
      thickened feedings over 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2021</start_date>
  <completion_date type="Anticipated">August 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of persistent symptoms and repeat hospitalizations over 6-month follow-up period</measure>
    <time_frame>6 months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of persistent symptoms and hospitalization risk over the full 12-month follow-up period</measure>
    <time_frame>12 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Brief Resolved Unexplained Event</condition>
  <condition>Apparent Life Threatening Event</condition>
  <condition>Oropharyngeal Dysphagia</condition>
  <arm_group>
    <arm_group_label>Infants with BRUE receiving thickened feeds</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Infants with BRUE not receiving thickened feeds</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Thickened feeds</intervention_name>
    <description>Thickened feeds directed by medical team</description>
    <arm_group_label>Infants with BRUE receiving thickened feeds</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Non-thickened feeds</intervention_name>
    <description>Non-thickened feeds directed by medical team</description>
    <arm_group_label>Infants with BRUE not receiving thickened feeds</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be eligible for the study if they are less than 1 year of age and&#xD;
        admitted to Boston Children's Hospital after experiencing first lifetime BRUE&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Less than 1 year of age&#xD;
&#xD;
          -  Admitted to Boston Children's Hospital after experiencing first lifetime brief&#xD;
             resolved unexplained event.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any pre-existing medical diagnoses that exclude brief resolved unexplained event&#xD;
             diagnosis including seizure disorders and cyanotic congenital heart disease&#xD;
&#xD;
          -  Already receiving thickened liquids for treatment of another condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Months</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel R Duncan, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rachel Rosen, MD, MPH</last_name>
    <role>Study Director</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sudarshan Jadcherla, MD</last_name>
    <role>Study Director</role>
    <affiliation>Nationwide Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Taher Omari, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Flinders University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Samuel Nurko, MD, MPH</last_name>
    <role>Study Director</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniel R Duncan, MD, MPH</last_name>
    <phone>6173550897</phone>
    <email>daniel.duncan@childrens.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel R Duncan, MD, MPH</last_name>
      <phone>617-355-0897</phone>
      <email>daniel.duncan@childrens.harvard.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>31103259</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>27741062</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>36336644</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>June 20, 2023</last_update_submitted>
  <last_update_submitted_qc>June 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Daniel Duncan</investigator_full_name>
    <investigator_title>Assistant Professor of Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</mesh_term>
    <mesh_term>Brief, Resolved, Unexplained Event</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04477460
org study id: ObservationalBRUE
secondary id: K23DK127251
nct id: NCT04477460
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This observational study will examine the effects of thickened feeds on clinical outcomes and
      healthcare utilization in infants with brief resolved unexplained event (BRUE).
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.
observational model: Cohort
time perspective: Prospective
measure: Frequency of persistent symptoms and repeat hospitalizations over 6-month follow-up period
time frame: 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.
measure: Frequency of persistent symptoms and hospitalization risk over the full 12-month follow-up period
time frame: 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.
arm group label: Infants with BRUE receiving thickened feeds
arm group label: Infants with BRUE not receiving thickened feeds
intervention type: Dietary Supplement
intervention name: Thickened feeds
description: Thickened feeds directed by medical team
arm group label: Infants with BRUE receiving thickened feeds
intervention type: Dietary Supplement
intervention name: Non-thickened feeds
description: Non-thickened feeds directed by medical team
arm group label: Infants with BRUE not receiving thickened feeds
Urine samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 0 Months
maximum age: 12 Months
healthy volunteers: No
last name: Daniel R Duncan, MD, MPH
role: Principal Investigator
affiliation: Boston Children's Hospital
last name: Rachel Rosen, MD, MPH
role: Study Director
affiliation: Boston Children's Hospital
last name: Sudarshan Jadcherla, MD
role: Study Director
affiliation: Nationwide Children's Hospital
last name: Taher Omari, PhD
role: Study Director
affiliation: Flinders University
last name: Samuel Nurko, MD, MPH
role: Study Director
affiliation: Boston Children's Hospital
last name: Daniel R Duncan, MD, MPH
phone: 6173550897
email: daniel.duncan@childrens.harvard.edu
facility: 
status: Recruiting
contact: 
country: United States
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: 31103259
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: 27741062
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.
PMID: 36336644
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Daniel Duncan
investigator title: Assistant Professor of Pediatrics
mesh term: Deglutition Disorders
mesh term: Brief, Resolved, Unexplained Event