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NCT04477460 · ClinicalTrials.gov registry record
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
A clinical trial of Oropharyngeal Dysphagia and Brief Resolved Unexplained Event, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- 250
- Enrollment target
- 1
- Study location
NCT04477460: Recruiting study of Oropharyngeal Dysphagia and Brief Resolved Unexplained Event, sponsored by Boston Children's Hospital.
NCT04477460 is a study of Oropharyngeal Dysphagia and Brief Resolved Unexplained Event that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 250 participants, above the 75-participant average among 7 other Oropharyngeal Dysphagia trials with a reported enrollment target (233% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04477460, a study of Oropharyngeal Dysphagia and Brief Resolved Unexplained Event, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- 250 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
Frequency of persistent symptoms and repeat hospitalizations over the 6 months after enrollment, with a comparison between those receiving and not receiving thickened feeds.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Thickened feeds
- DIETARY_SUPPLEMENT Non-thickened feeds
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2026-08-31 |
What NCT04477460 shows while recruiting
NCT04477460 is an observational study that tracks outcomes without assigning an intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 75-participant average among 7 other Oropharyngeal Dysphagia trials with a reported enrollment target (233% higher).
The record links to 3 conditions, with Oropharyngeal Dysphagia appearing as the primary indexed condition, and to 2 interventions - of which Thickened feeds is the first listed.
NCT04477460 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04477460 about?
NCT04477460 is a clinical study titled "Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event". This observational study will examine the effects of thickened feeds on clinical outcomes and healthcare utilization in infants with brief resolved unexplained event (BRUE).
What is the current status of trial NCT04477460?
This trial is currently recruiting. The enrollment target is 250 participants. The study started on 2021-04-01. Estimated completion is 2026-08-31.
What conditions does trial NCT04477460 study?
This clinical trial studies the following conditions: Oropharyngeal Dysphagia, Brief Resolved Unexplained Event, Apparent Life Threatening Event.
What interventions are being tested in trial NCT04477460?
The interventions under investigation include: Thickened feeds (DIETARY_SUPPLEMENT), Non-thickened feeds (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04477460?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04477460 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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