Overseen bySara Burnham
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Waitlist Available
Sponsor: Connecticut Children's Medical Center
No Placebo Group
Trial Summary
What is the purpose of this trial?Infants are typically fed in a cradled, upright position, however feeding specialists/SLPs often position infants in a side-lying position to promote safe, quality, and neurodevelopmentally protective feeding which is supported by currently available literature. Side-lying position is often recommended by feeding specialists to reduce the risk for aspiration and improve other components of infant swallow function. However, there is no literature directly assessing airway protection during the swallow with the infant in the side-lying versus upright positions. The goal of this study is to conduct an instrumental assessment (Modified Barium Swallow/Videofluoroscopic Swallow Study) in these different positions (upright versus side-lying) to determine if there is a difference in airway compromise. The target population are infants between post-menstrual ages of 38-56 weeks who are referred for a modified barium swallow study.
Eligibility Criteria
This trial is for infants aged 38-56 weeks post-menstrual who have been referred for a Modified Barium Swallow (MBS) study due to suspected oropharyngeal dysphagia. Only those confirmed with pharyngeal dysphagia will be included in the final analysis. Infants must be medically stable and able to maintain side-lying or upright positions for at least 3 minutes.Treatment Details
The study tests whether feeding infants in a side-lying position, as opposed to the typical upright position, affects their risk of aspiration and overall swallow function. It involves an instrumental assessment using MBS to compare airway protection between these two positions.
2Treatment groups
Active Control
Group I: Sidelying, then UprightActive Control2 Interventions
Positioning in sidelying on radiology table for assessment, then will be positioned upright in tumbleform. Same bottle and liquid viscosities will be assessed in both positions.
Group II: Upright, then SidelyingActive Control2 Interventions
Positioned upright in tumbleform, then will be positioned sidelying on radiology table for assessment. Same bottle and liquid viscosities will be assessed in both positions.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Connecticut Children's Medical CenterHartford, CT
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Who is running the clinical trial?
Connecticut Children's Medical CenterLead Sponsor