Clinical trial NCT04477460: Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
Official title: Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brief Resolved Unexplained Event
Apparent Life Threatening Event
Oropharyngeal Dysphagia
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-07-20
Enrollment: 250
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: This observational study will examine the effects of thickened feeds on clinical outcomes and healthcare utilization in infants with brief resolved unexplained event (BRUE).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Less than 1 year of age
* Admitted to Boston Children's Hospital after experiencing first lifetime brief resolved unexplained event.

Exclusion Criteria:

* Any pre-existing medical diagnoses that exclude brief resolved unexplained event diagnosis including seizure disorders and cyanotic congenital heart disease
* Already receiving thickened liquids for treatment of another condition

Primary outcomes:
measure: Frequency of persistent symptoms and repeat hospitalizations over 6-month follow-up period
timeFrame: 6 months
Secondary outcomes:
measure: Frequency of persistent symptoms and hospitalization risk over the full 12-month follow-up period
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Daniel R Duncan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Rachel Rosen, MD, MPH
role: STUDY_DIRECTOR
affiliation: Nationwide Children's Hospital
name: Sudarshan Jadcherla, MD
role: STUDY_DIRECTOR
affiliation: Flinders University
name: Taher Omari, PhD
role: STUDY_DIRECTOR
affiliation: Boston Children's Hospital
name: Samuel Nurko, MD, MPH
role: STUDY_DIRECTOR
References:
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: 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: 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.