Dysphagia Clinical Trial
Official title:
Neonatal Esophagus and Airway Interactions in Health and Disease
Verified date | August 2021 |
Source | Nationwide Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 109 |
Est. completion date | August 30, 2020 |
Est. primary completion date | August 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 38 Weeks to 60 Weeks |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | The Research Institute at Nationwide Children's Hospital | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Sudarshan Jadcherla | Medical College of Wisconsin, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Ohio State University |
United States,
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. Epub 2007 Aug 23. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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