The Effect of Body Position on Oropharyngeal Swallow Function in Infants

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Connecticut Children's Medical Center
Study ID
NCT05874102
Status
Enrolling By Invitation

Conditions

  • Aspiration

Eligibility Criteria

Sex
ALL
Age
38 Weeks - 56 Weeks
Healthy Volunteers
Accepted

Interventions

  • Sidelying — OTHER
    Position sidelying then Upright
  • Upright — OTHER
    Position upright then sidelying

Study Details

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.

Key Dates

Start date
Dec 20, 2023
Status verified
May 2026
Primary completion
Dec 20, 2024
Completion
Aug 15, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Sidelying, then Upright
    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.
  • Active Comparator: Upright, then Sidelying
    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.

Primary Outcome Measure

Airway invasion outcome [ Time Frame: Highest rating on the Penetration-Aspiration Scale will be recorded for each trial for each infant for the entirety of the study, roughly 1 year. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Connecticut Children's Medical CenterHartfordConnecticut06106-

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Connecticut Children's Medical Center· Hartford, CT

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