Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04504227
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2020-08-05
Brief Title:
Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Effect of Thickened Feeds on Swallow Physiology in Children With Dysphagia
Status:
RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
This study will examine the effects of varying liquid viscosity on swallow physiology in infants with oropharyngeal dysphagia and brief resolved unexplained event BRUE and other children with dysphagia that would be at risk for symptoms of swallow dysfunction
Detailed Description:
Infants with oropharyngeal dysphagia and in particular brief resolved unexplained events BRUE are a significant driver of pediatric health care expenditure since the mechanism for their swallow dysfunction is incompletely understood and therefore frequently goes unrecognized and untreated We hypothesize that infants with oropharyngeal dysphagia and BRUE have measurable differences in swallowing physiology to explain their symptoms of cyanotic choking spells that these differences can be quantified using pharyngeal high resolution impedance-manometry compared to videofluoroscopic swallow study results and that this swallowing dysfunction can be safely corrected with a change of formula viscosity Through this research project we will systematically investigate the effects of thickened feedings on swallow function in infants with dysphagia and BRUE and perform detailed physiology studies on pharyngeal and esophageal motility as critical mediators of improved outcomes
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23DK127251 | NIH | None | httpsreporternihgovquickSearchK23DK127251 |