NCT02583360

Mechanisms and Management of Infant Dysphagia

Neonatal Esophagus and Airway Interactions in Health and Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Sudarshan Jadcherla · Academic / Other
• Sex: All
• Age: 38 Weeks – 60 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Dysphagia
• Airway Aspiration
• Airway Penetration

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Combined testing (diagnostic VFSS + research HRM) + Parent Preferred Therapy	Addition of research HRM along with diagnostic VFSS with parental choice of therapy

Timeline

• Start date: 2015-10-02
• Primary completion: 2020-08-30
• Completion: 2020-08-30
• First posted: 2015-10-22
• Last updated: 2021-08-23
• Results posted: 2020-12-16

Locations

1 site across 1 country: United States