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Completed

NCT Number: NCT02583360

Mechanisms and Management of Infant Dysphagia

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.

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Key information

Age range

38 week–60 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Research Institute at Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Diagnostic Test

Addition of research HRM along with diagnostic VFSS with parental choice of therapy

Primary outcomes

  1. Number of Participants With Successful Safe Oral Feeding

    Time frame: 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 outcomes

  1. Weight Growth Velocity in Grams/Day

    Time frame: 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.

  2. Hospital Length of Stay From Admission to Discharge in Days

    Time frame: from hospital admission until discharge

    The investigators will track the subjects length of hospitalization which included their initial study procedure.

Sponsors and collaborators

Lead sponsor

Sudarshan Jadcherla

Other

Collaborators

  • Medical College of Wisconsin
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Ohio State University

Registry information

Official study title

Neonatal Esophagus and Airway Interactions in Health and Disease

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2015
Registry last updated
Aug 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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