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| ID | Type | Description | Link |
|---|---|---|---|
| P01DK068051 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Ohio State University | OTHER |
| Medical College of Wisconsin | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study | Active Comparator | Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy. |
|
| Control | No Intervention | Eligible subjects who had VFSS alone with provider recommendations from the same single center. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined testing (diagnostic VFSS + research HRM) + Parent Preferred Therapy | Diagnostic Test | Addition of research HRM along with diagnostic VFSS with parental choice of therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 4 weeks after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Hospital Length of Stay From Admission to Discharge in Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sudarshan R Jadcherla, MD | Nationwide Children's Hospital | Principal Investigator |
| Reza Shaker, MD | Medical College of Wisconsin | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Research Institute at Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19179881 | Background | Jadcherla SR, Stoner E, Gupta A, Bates DG, Fernandez S, Di Lorenzo C, Linscheid T. Evaluation and management of neonatal dysphagia: impact of pharyngoesophageal motility studies and multidisciplinary feeding strategy. J Pediatr Gastroenterol Nutr. 2009 Feb;48(2):186-92. doi: 10.1097/MPG.0b013e3181752ce7. | |
| 21694638 | Background | Jadcherla SR, Peng J, Moore R, Saavedra J, Shepherd E, Fernandez S, Erdman SH, DiLorenzo C. Impact of personalized feeding program in 100 NICU infants: pathophysiology-based approach for better outcomes. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):62-70. doi: 10.1097/MPG.0b013e3182288766. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study | Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy. Combined Diagnostic testing (VFSS + HRM) + Parent Preferred Therapy: HRM along with diagnostic VFSS with parental choice of therapy |
| FG001 | Control | Eligible subjects who had VFSS alone with provider recommendations from the same single center. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study | Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy. Combined Diagnostic testing (VFSS + HRM) + Parent Preferred Therapy: HRM along with diagnostic VFSS with parental choice of therapy |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Up to 4 weeks after enrollment |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study | Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy. Combined Diagnostic testing (VFSS + HRM) + Parent Preferred Therapy: HRM along with diagnostic VFSS with parental choice of therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sudarshan Jadcherla MD | The Research Institute at Nationwide Children's Hospital | 614-355-6433 | sudarshan.jadcherla@nationwidechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 2, 2020 | Oct 25, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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Eligible consented subjects (study) from a single center will undergo standard of care diagnostic VFSS in combination with the research intervention of utilizing manometry procedures to measure pharyngo-esophageal motility to aid with precise diagnosis, either concurrent or sequential. They will then have parental choice of preferred feeding therapy based on combined testing methods rather than therapy being prescribed by the VFSS results. The controls are those who had VFSS alone (standard of care) with treatment based solely on VFSS guided provider recommendations from the same single center.
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The investigators will track the subjects length of hospitalization which included their initial study procedure. |
| from hospital admission until discharge |
| 18035137 | Background | Jadcherla SR, Gupta A, Stoner E, Fernandez S, Shaker R. Pharyngeal swallowing: defining pharyngeal and upper esophageal sphincter relationships in human neonates. J Pediatr. 2007 Dec;151(6):597-603. doi: 10.1016/j.jpeds.2007.04.042. Epub 2007 Aug 23. |
| 25279989 | Background | Jadcherla SR, Shubert TR, Gulati IK, Jensen PS, Wei L, Shaker R. Upper and lower esophageal sphincter kinetics are modified during maturation: effect of pharyngeal stimulus in premature infants. Pediatr Res. 2015 Jan;77(1-1):99-106. doi: 10.1038/pr.2014.147. Epub 2014 Oct 3. |
| Control |
Eligible subjects who had VFSS alone with provider recommendations from the same single center. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Postmenstrual age at time of study | Mean | Full Range | weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Unable to get growth velocity on all patients as they were not all hospitalized or weight at 4 weeks after study | Posted | Mean | Standard Deviation | grams/day | 4 weeks |
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|
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| Secondary | 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. | Some patients in study group were outpatient | Posted | Mean | Standard Deviation | days | from hospital admission until discharge |
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|
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| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Control | Eligible subjects who had VFSS alone with provider recommendations from the same single center. | 0 | 49 | 0 | 49 | 0 | 49 |
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| D010038 | Otorhinolaryngologic Diseases |