Mechanisms and Management of Infant Dysphagia

Not Applicable

Completed

Conditions: Dysphagia
Airway Penetration
Airway Aspiration

Interventions: Diagnostic Test: Combined testing (diagnostic VFSS + research HRM) + Parent Preferred Therapy

Registration Number: NCT02583360

Lead Sponsor: Sudarshan Jadcherla

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 109

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study	Combined testing (diagnostic VFSS + research HRM) + Parent Preferred Therapy	Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Successful Safe Oral Feeding	Up to 4 weeks after enrollment	The primary endpoint is the feeding success defined as full oral feeding (no tube feeds feeds) without symptoms that require interventions

Secondary Outcome Measures

Name	Time	Method
Hospital Length of Stay From Admission to Discharge in Days	from hospital admission until discharge	The investigators will track the subjects length of hospitalization which included their initial study procedure.
Weight Growth Velocity in Grams/Day	4 weeks	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.