Mechanisms and Management of Infant Dysphagia

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.

Study Overview

• Status: Completed
• Conditions: Dysphagia; Airway Aspiration; Airway Penetration
• Intervention / Treatment: Diagnostic test: Combined testing (diagnostic VFSS + research HRM) + Parent Preferred Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • The Research Institute at Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study; Eligible subjects (study) will undergo diagnostic VFSS in combination with manometry, either concurrent or sequential. They will have parental choice of preferred feeding therapy.	Diagnostic test: Combined testing (diagnostic VFSS + research HRM) + Parent Preferred Therapy; Addition of research HRM along with diagnostic VFSS with parental choice of therapy
No Intervention: Control; Eligible subjects who had VFSS alone with provider recommendations from the same single center.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sudarshan Jadcherla
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Medical College of Wisconsin; Ohio State University
• Investigators: Principal Investigator: Sudarshan R Jadcherla, MD, The Research Institute at Nationwide Children's Hospital; Study Chair: Reza Shaker, MD, Medical College of Wisconsin

Publications and helpful links

General Publications

• Jadcherla SR, Stoner E, Gupta A, Bates DG, Fernandez S, Di Lorenzo C, Linscheid T. Evaluation and management of neonatal dysphagia: impact of pharyngoesophageal motility studies and multidisciplinary feeding strategy. J Pediatr Gastroenterol Nutr. 2009 Feb;48(2):186-92. doi: 10.1097/MPG.0b013e3181752ce7.
• Jadcherla SR, Peng J, Moore R, Saavedra J, Shepherd E, Fernandez S, Erdman SH, DiLorenzo C. Impact of personalized feeding program in 100 NICU infants: pathophysiology-based approach for better outcomes. J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):62-70. doi: 10.1097/MPG.0b013e3182288766.
• Jadcherla SR, Gupta A, Stoner E, Fernandez S, Shaker R. Pharyngeal swallowing: defining pharyngeal and upper esophageal sphincter relationships in human neonates. J Pediatr. 2007 Dec;151(6):597-603. doi: 10.1016/j.jpeds.2007.04.042. Epub 2007 Aug 23.
• Jadcherla SR, Shubert TR, Gulati IK, Jensen PS, Wei L, Shaker R. Upper and lower esophageal sphincter kinetics are modified during maturation: effect of pharyngeal stimulus in premature infants. Pediatr Res. 2015 Jan;77(1-1):99-106. doi: 10.1038/pr.2014.147. Epub 2014 Oct 3.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2015
• Primary Completion (Actual): August 30, 2020
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: October 20, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (Estimate): October 22, 2015

Study Record Updates

• Last Update Posted (Actual): August 23, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Dysphagia; Infant; Feeding difficulties
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 14-00794; P01DK068051 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No