Columbus, Ohio 43205


Purpose:

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 summary:

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.


Criteria:

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


NCT ID:

NCT02583360


Primary Contact:

Principal Investigator
Sudarshan R Jadcherla, MD
The Research Institute at Nationwide Children's Hospital

Rebecca Moore, MACPR, BSN
Phone: 6143556635
Email: Rebecca.Moore@nationwidechildrens.org


Backup Contact:

Email: erika.osborn@nationwidechildrens.org
Erika Osborn, MSN, NNP
Phone: 614 355-6643


Location Contact:

Columbus, Ohio 43205
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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