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Body Position for Aspiration in Infants

N/A

Waitlist Available

Led By Sara Burnham

Research Sponsored by Connecticut Children's Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare how safe it is for babies to swallow in an upright vs. side-lying position to protect their airways.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves standard feeding positions and diagnostic imaging, there are minimal expected side effects; however, discomfort from positioning or reactions related to the barium used in MBS may occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Airway invasion outcome

Secondary study objectives

Suck-swallow-breathe (SSwB) coordination outcome

Swallow initiation outcome

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Do I qualify?Apply below to find out