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:
Boston Children's Hospital
Organization:
Study Overview
Official Title:
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| K23DK127251 | NIH | None | https://reporter.nih.gov/quic… | View |