Mechanisms and Management of Infant Dysphagia

NCT02583360 | Completed Results DMC

• 2 other identifiers: 14-00794P01DK068051
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysphagia; Airway Aspiration; Airway Penetration

Keywords

Infant; Feeding difficulties; Dysphagia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Weight Growth Velocity in Grams/Day

  4 weeks

• Hospital Length of Stay From Admission to Discharge in Days

  from hospital admission until discharge

Study Arms (2)

Study

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

Eligible subjects who had VFSS alone with provider recommendations from the same single center.

Interventions

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

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

Study

Eligibility Criteria

• Age: 38 Weeks - 60 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sudarshan Jadcherla: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Ohio State University: collaborator
• Medical College of Wisconsin: collaborator

Study Sites (1)

The Research Institute at Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (4)

• 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.

  PMID: 19179881 BACKGROUND

• 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.

  PMID: 21694638 BACKGROUND

• 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.

  PMID: 18035137 BACKGROUND

• 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.

  PMID: 25279989 BACKGROUND

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Sudarshan Jadcherla MD
• Organization: The Research Institute at Nationwide Children's Hospital

sudarshan.jadcherla@nationwidechildrens.org

614-355-6433

Study Officials

• Sudarshan R Jadcherla, MD

  The Research Institute at Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

• Reza Shaker, MD

  Medical College of Wisconsin

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Eligible consented subjects (study) from a single center will undergo standard of care diagnostic VFSS in combination with the research intervention of utilizing manometry procedures to measure pharyngo-esophageal motility to aid with precise diagnosis, either concurrent or sequential. They will then have parental choice of preferred feeding therapy based on combined testing methods rather than therapy being prescribed by the VFSS results. The controls are those who had VFSS alone (standard of care) with treatment based solely on VFSS guided provider recommendations from the same single center.

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 22, 2015
• Study Start: October 2, 2015
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: August 23, 2021
• Results First Posted: December 16, 2020

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)