Mechanisms and Management of Infant Dysphagia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Neonatal Esophagus and Airway Interactions in Health and Disease

Conditions
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Dysphagia, Airway Aspiration, Airway Penetration

Intervention / Treatment
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* Diagnostic Test: Combined testing (diagnostic VFSS + research HRM) + Parent Preferred Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants with feeding-related aero-digestive symptoms ≤60 weeks PMA (both pre-term and full term) History of orally feeding ≥ 25% of least 50% of prescribed feeding volume Room air or supplemental oxygen of ≤1liter/minute (LPM) Exclusion Criteria: Direct breast feeding exclusively Known genetic, metabolic or syndromic disease Neurological diseases such as Grade 3 or 4 intraventricular hemorrhage (IVH) or intracranial hemorrhage (ICH), moderate to severe perinatal asphyxia or stroke Craniofacial, airway or foregut malformations History of craniofacial, foregut, ears, nose and throat (ENT) or neurosurgery

Ages Eligible for Study
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Minimum Age: 38 Weeks
Maximum Age: 60 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study<br>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<br>* Addition of research HRM along with diagnostic VFSS with parental choice of therapy<br>|
| No Intervention: Control<br>Eligible subjects who had VFSS alone with provider recommendations from the same single center. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | The investigators will track the subjects length of hospitalization which included their initial study procedure. | from hospital admission until discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant, Feeding difficulties, Dysphagia