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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Airway invasion outcome

Secondary outcome measures

Suck-swallow-breathe (SSwB) coordination outcome

Swallow initiation outcome

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

Find a Location

Who is running the clinical trial?

Connecticut Children's Medical CenterLead Sponsor

71 Previous Clinical Trials

31,474 Total Patients Enrolled

Sara BurnhamPrincipal InvestigatorConnecticut Children's Medical Center

Media Library

Sidelying Clinical Trial Eligibility Overview. Trial Name: NCT05874102 — N/A

Aspiration Research Study Groups: Sidelying, then Upright, Upright, then Sidelying

Aspiration Clinical Trial 2023: Sidelying Highlights & Side Effects. Trial Name: NCT05874102 — N/A

Sidelying 2023 Treatment Timeline for Medical Study. Trial Name: NCT05874102 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any particular individuals who would be ideal candidates for this trial?

"Patients aspiring to be enrolled in this clinical trial should be 38-56 weeks old. As of now, 40 participants have yet to join the study."

Answered by AI

Is this study including geriatric patients?

"This trial accepts patients who meet the requirements of being between 38 and 56 weeks old. Additionally, there are 3 studies dedicated to those under 18 years of age and 4 for senior citizens above 65."

Answered by AI

Are any new participants being welcomed to join this trial currently?

"According to clinicaltrials.gov, the search for participants in this trial has been halted since May 16th 2023. However, there are 7 other trials actively enrolling patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effect of Body Position on Oropharyngeal Swallow Function in Infants

2023. "The Effect of Body Position on Oropharyngeal Swallow Function in Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05874102.