An interventional study of Combined testing (diagnostic VFSS + research HRM) + Parent Preferred Therapy in Dysphagia, Airway Aspiration and Airway Penetration, sponsored by Sudarshan Jadcherla. Completed at 1 site in United States. Open to participants aged 38 Weeks to 60 Weeks. Per ClinicalTrials.gov, last updated 2021-08-23.
Sponsored by Sudarshan Jadcherla · Not applicable, Interventional, and Diagnostic
The purpose of the investigator's study is to evaluate the causes of feeding difficulty in infants. New treatments can be possible only if the cause is known. In this study, the investigator plans to evaluate the movement of the muscles in an infant's mouth, throat (pharynx) and food pipe (esophagus) that are responsible for moving the food down into the stomach and that help protect an infants airway.
Infants with chronic feeding difficulties exhibit inadequacy of suck-swallow and breathe coordination, regurgitation or vomiting, gastroesophageal reflux disease, and airway aspiration. Often these infants must rely on feeding tubes, either inserted through the nose or surgically placed, to meet their nutrition and hydration needs until they are able to orally feed safely, effectively, and efficiently. The process of assessment and treatment of swallowing disorders is often stressful for the infants and their providers, including parents. The goal of this study is to combine two commonly used diagnostic techniques (video fluoroscopy swallow studies and esophageal manometry) to more comprehensively evaluate feeding from the mouth to the stomach in infants. The hope is that by doing so treatment strategies can be improved.
: Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy. The data is from single center prospective observational study. The controls are those who had VFSS alone with provider recommendations from the same single center.
In addition, we are also embarking on alternate strategies to achieve the original stated aims: 1) Mechanisms of dysphagia is ascertained by studying concurrent recordings of VFSS and manometry. 2) Feeding outcomes of Dysphagic infants are ascertained by evaluating the discharge outcomes and 1-year feeding outcomes among those that had evaluation of dysphagia using VFSS. 3) Dysphagic infants that had sequential VFSS and manometry studies are evaluated to test which method is a better predictor of stated outcomes.
710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.
This study's enrollment of 109 is above the median of 60 across 471 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →Sudarshan Jadcherla is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy.
Diagnostic Test: Combined testing (diagnostic VFSS + research HRM) + Parent Preferred Therapy
Eligible subjects who had VFSS alone with provider recommendations from the same single center.
Addition of research HRM along with diagnostic VFSS with parental choice of therapy
Number of Participants With Successful Safe Oral Feeding
The primary endpoint is the feeding success defined as full oral feeding (no tube feeds feeds) without symptoms that require interventions
Time frame: Up to 4 weeks after enrollment
Weight Growth Velocity in Grams/Day
The investigators will measure and track growth velocity (grams/day) during this time period. This will be completed through chart reviews of weight from subsequent clinic visits and parent interviews.
Time frame: 4 weeks
Hospital Length of Stay From Admission to Discharge in Days
The investigators will track the subjects length of hospitalization which included their initial study procedure.
Time frame: from hospital admission until discharge
| Milestone | Study | Control |
|---|---|---|
| Started | 60 | 49 |
| Completed | 60 | 49 |
| Not completed | 0 | 0 |
The primary endpoint is the feeding success defined as full oral feeding (no tube feeds feeds) without symptoms that require interventions
| Participants | Study | Control |
|---|---|---|
| Number of Participants With Successful Safe Oral Feeding | 51 | 31 |
The investigators will measure and track growth velocity (grams/day) during this time period. This will be completed through chart reviews of weight from subsequent clinic visits and parent interviews.
| grams/day | Study | Control |
|---|---|---|
| Weight Growth Velocity in Grams/Day | 27 ± 11.1 | 26.7 ± 11.5 |
The investigators will track the subjects length of hospitalization which included their initial study procedure.
| days | Study | Control |
|---|---|---|
| Hospital Length of Stay From Admission to Discharge in Days | 43.6 ± 49.7 | 49.9 ± 58.4 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
| Control | 0/49 (0%) | 0/49 (0%) | 0/49 (0%) |
| Age, Categorical(Participants) | Study | Control | Total |
|---|---|---|---|
| <=18 years | 60 | 49 | 109 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(weeks) | Study | Control | Total |
|---|---|---|---|
| Mean | 45.7 (36.4 to 60.7) | 45.7 (38.4 to 57) | 45.7 (36.4 to 60.7) |
| Sex: Female, Male(Participants) | Study | Control | Total |
|---|---|---|---|
| Female | 26 | 30 | 56 |
| Male | 34 | 19 | 53 |
| Race (NIH/OMB)(Participants) | Study | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 9 | 15 | 24 |
| White | 50 | 31 | 81 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Study | Control | Total |
|---|---|---|---|
| United States | 60 | 49 | 109 |
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Plan to share: No
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Sudarshan Jadcherla