Mechanisms and Management of Infant Dysphagia

Therapuetic Areas:Gastroenterology
Age Range:Any
Start Date:March 2015
End Date:August 2019
Contact:Rebecca Moore, MACPR, BSN

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Neonatal Esophagus and Airway Interactions in Health and Disease

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.

Feeding difficulties are complex conditions. Simple solitary therapies are not feasible, and
compliance is difficult as day-to-day modifications are practiced based on clinical
relevance. Therefore, to improve recruitment and compliance to feeding therapies (flow
regulated or thickener use), we have now adopted Parent Preferred Therapy for the feeding
modification. The treatment arms will still be the same at initiation. Subsequent changes to
therapies will be measured.

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.

Inclusion Criteria:

- Infants that display laryngeal penetration and/or aspiration on Video Fluoroscopic
Swallow Study (VFSS)

- Gestational Age ≤ 42 weeks

- Orally feeding ≥ 50% of prescribed feeding volume

- Room air or supplemental oxygen of ≤1liter/minute (LPM)

Exclusion Criteria:

- Direct breast feeding ≥ 50% of daily feeding occurrences

- Known genetic, metabolic or syndromic disease

- Neurological diseases such as Grade 3 or 4 intraventricular hemorrhage (IVH) or
intracranial hemorrhage (ICH), perinatal asphyxia or stroke

- Craniofacial, airway or foregut malformations

- History of craniofacial, foregut, ears, nose and throat (ENT) or neurosurgery
We found this trial at
Columbus, OH
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