The Effect of Body Position on Oropharyngeal Swallow Function in Infants

NCT05874102 | Completed

• 1 other identifier: 22-078
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aspiration

Outcome Measures

Primary Outcomes (1)

• Airway invasion outcome

  This will be measured via the Penetration-Aspiration Scale (Rosenbek et al., 1996). The PAS is an 8-point scale that is a reliable measure of airway invasion in infant bottle-feeders (Gosa \& Suiter, 2011; Martin-Harris et al., 2020). The scale ranges from 1-8, with 1 indicating no airway invasion and an 8 indicating silent aspiration.

  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.

Secondary Outcomes (2)

• Swallow initiation outcome

  Lowest location of bolus (presenting highest risk) will be recorded for each trial for each infant for the entirety of the study, roughly 1 year.

• Suck-swallow-breathe (SSwB) coordination outcome

  number of sucks, swallows, and breaths will be counted for each swallowing trial for each infant for the entirety of the study, roughly 1 year.

Study Arms (2)

Sidelying, then Upright

ACTIVE COMPARATOR

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.

Other: Sidelying; Other: Upright

Upright, then Sidelying

ACTIVE COMPARATOR

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.

Other: Sidelying; Other: Upright

Interventions

Sidelying OTHER

Position sidelying then Upright

Also known as: Upright

Sidelying, then Upright; Upright, then Sidelying

Upright OTHER

Position upright then sidelying

Also known as: Sidelying

Sidelying, then Upright; Upright, then Sidelying

Eligibility Criteria

• Age: 38 Weeks - 56 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The age of the infant at the time of the study must be between 38 to 56 weeks post-menstrual age (PMA) (American Academy of Pediatrics, 2004; Balest et al., 2021, Han et al. 2020; McGratten et al., 2020).
• Infant has been referred for an MBS by their physician based on clinical need (suspected oropharyngeal dysphagia)
• Only infants with confirmed pharyngeal dysphagia, as defined by at least one airway invasion event on their MBS, will be included in final data analysis

You may not qualify if:

• Infants who are deemed not medically stable enough to complete an MBS
• Infants who are deemed unable to maintain a side-lying or upright position for at least 3 minutes

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Interventions

URO protein, Arabidopsis

Study Officials

• Sara Burnham

  Connecticut Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: May 24, 2023
• Study Start: December 20, 2023
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)