Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02583360
Other study ID # 14-00794
Secondary ID P01DK068051
Status Completed
Phase N/A
First received
Last updated
Start date October 2, 2015
Est. completion date August 30, 2020

Study information

Verified date August 2021
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Diagnostic Test:
Combined testing (diagnostic VFSS + research HRM) + Parent Preferred Therapy
Addition of research HRM along with diagnostic VFSS with parental choice of therapy

Locations

Country Name City State
United States The Research Institute at Nationwide Children's Hospital Columbus Ohio

Sponsors (4)

Lead Sponsor Collaborator
Sudarshan Jadcherla Medical College of Wisconsin, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Ohio State University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

Outcome

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03711474 - Dysphagia Following Anterior Cervical Spine Surgery; Single Dose Steroid vs Saline (DysDexVSSal) Phase 4
Enrolling by invitation NCT04074356 - Non-invasive Markers of Esophageal Function in Adults N/A
Suspended NCT04349462 - Post Critical Illness Dysphagia in the Intensive Care Unit N/A
Not yet recruiting NCT05982977 - Study on the Effect Mechanism of Acupuncture Combined With Swallowing Training in Oral Dysphagia of Stroke N/A
Recruiting NCT03605381 - MORbidity PRevalence Estimate In StrokE
Active, not recruiting NCT03455608 - PRO-ACTIVE: Prophylactic Swallow Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer N/A
Active, not recruiting NCT03604822 - Music Therapy Protocol to Support Bulbar and Respiratory Functions in ALS N/A
Recruiting NCT03682081 - Interventions for Patients With Alzheimer's Disease and Dysphagia N/A
Completed NCT05700838 - Refining Cough Skill Training in Parkinson's Disease and Dysphagia Phase 1
Not yet recruiting NCT04064333 - Slow-Stream Expiratory Muscle Strength Training for Veterans With Dysphagia Living in Long-term Care N/A
Not yet recruiting NCT02724761 - Prophylactic Racemic Epinephrine in Anterior Cervical Discectomy and Fusion N/A
Completed NCT02927691 - Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial Phase 2
Completed NCT01919112 - Fostering Eating After Stroke With Transcranial Direct Current Stimulation N/A
Completed NCT01370083 - Tongue Pressure Profile Training for Dysphagia Post Stroke Phase 2
Withdrawn NCT01200147 - Effectiveness of Rupture of Schatzki's Ring Using Biopsy Forceps Versus SIngle Dilation N/A
Completed NCT01723358 - Neuromuscular Electrical Stimulation (NMES) Treatment Technique Therapy in the Management of Young Infants With Severe Dysphagia Phase 2
Completed NCT00570557 - Development of a Web-Based Course to Maintain Skills in Nurses Trained to Screen for Dysphagia N/A
Recruiting NCT00166751 - Sonographic Assessment of Laryngeal Elevation N/A
Completed NCT01476241 - Percutaneous Endoscopic Gastrostomy Tube Placement by Otorhinolaryngologist N/A
Completed NCT00717028 - Functional Endoscopic Evaluation of Swallowing N/A