Mechanisms and Management of Infant Dysphagia
Condition: Dysphagia; Airway Aspiration; Airway Penetration
MeSH terms: Deglutition Disorders
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Combined testing (diagnostic VFSS + research HRM) + Parent Preferred Therapy
Intervention type(s): Diagnostic Test
Intervention description(s): Addition of research HRM along with diagnostic VFSS with parental choice of therapy
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention 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)
Primary purpose: Diagnostic
Keywords: Infant; Feeding difficulties; Dysphagia