Mechanisms and Management of Infant Dysphagia

Sudarshan Jadcherla

Status: Completed

Conditions: Dysphagia; Airway Aspiration; Airway Penetration

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02583360

P01DK068051 (U.S. NIH Grant/Contract)

14-00794

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 38 to 60 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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109 participants in 2 patient groups

Study

Active Comparator group

Description:

Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy.

Treatment:

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

Control

No Intervention group

Description:

Eligible subjects who had VFSS alone with provider recommendations from the same single center.