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The Effect of Body Position on Oropharyngeal Swallow Function in Infants

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Lead sponsor: Connecticut Children's Medical Center to Connecticut Children's Medical Center Show 5 more changesShow less
    • Trial status changed: Enrolling by Invitation → Active, Not Recruiting
    • Study completion pushed from Aug 15, 2026 to Jul 15, 2027
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Site details revised
  2. Trial status: Completed to Enrolling by Invitation
    • Study completion date: Dec 20, 2024 to Aug 15, 2026
    v4
  3. Start date: Jan 13, 2023 to Dec 20, 2023
    • Trial status: Enrolling by Invitation to Completed
    • Primary and study completion dates changed from estimate of Dec 2024 to Dec 20, 2024
    v3
  4. Primary and study completion dates: Dec 2023 to Dec 2024v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05874102
Lead Sponsor Connecticut Children's Medical Center
Conditions
(from sponsor)		 Aspiration
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov