Apparent Life Threatening Event, Brief Resolved Unexplained Event, Oropharyngeal Dysphagia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTThickened feeds
Thickened feeds directed by medical team
DIETARY_SUPPLEMENTNon-thickened feeds
Non-thickened feeds directed by medical team
Sponsors
Boston Children's Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Months to 12 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of persistent symptoms and repeat hospitalizations over 6-month follow-up period | 6 months | Frequency of persistent symptoms and repeat hospitalizations over the 6 months after enrollment, with a comparison between those receiving and not receiving thickened feeds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of persistent symptoms and hospitalization risk over the full 12-month follow-up period | 12 months | 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. |
Countries
United States
Contacts
CONTACTDaniel R Duncan, MD, MPH
PRINCIPAL_INVESTIGATORDaniel R Duncan, MD, MPH
Boston Children's Hospital
STUDY_DIRECTORRachel Rosen, MD, MPH
Boston Children's Hospital
STUDY_DIRECTORSudarshan Jadcherla, MD
Nationwide Children's Hospital
STUDY_DIRECTORTaher Omari, PhD
Flinders University
STUDY_DIRECTORSamuel Nurko, MD, MPH
Boston Children's Hospital
Outcome results
None listed