N/A
N=109
Mechanisms and Management of Infant Dysphagia
Dysphagia · Airway Aspiration · Airway Penetration
Bottom Line
View on ClinicalTrials.gov: NCT02583360 ↗Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Number of Participants With Successful Safe Oral Feeding — 51; 31 Participants — p=0.008
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Combined testing (diagnostic VFSS + research HRM) + Parent Preferred Therapy (Diagnostic_test)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sudarshan Jadcherla
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Safe Oral Feeding |
51; 31 | 0.008 sig |
| SECONDARY Weight Growth Velocity in Grams/Day |
27; 26.7 | 0.907 |
| SECONDARY Hospital Length of Stay From Admission to Discharge in Days |
43.6; 49.9 | 0.592 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02583360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.