Feasibility of a new therapy for feeding disorders in infants
Safety and Feasibility of Aerodigestive Stimulation Therapy in Infants With Complex Feeding Difficulties
This study is testing a new therapy to help infants with feeding disorders improve their swallowing and reduce their need for tube feeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 1 Day to 8 Months |
| Sex | All |
| Sponsor | Nationwide Children's Hospital Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06118697 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety, feasibility, and effectiveness of a novel pharyngo-esophageal stimulation technique designed to improve swallowing and aerodigestive functions in infants at risk for chronic tube feeding. Participants will receive weekly stimulation treatments guided by High Resolution Impedance Manometry (HRIM) for four weeks, alongside oral feeding therapy. The study also includes daily feeding evaluations and parental education to enhance feeding compliance and reduce stress. The goal is to decrease reliance on tube feeding and improve overall feeding satisfaction for both infants and their families.
Who should consider this trial
Good fit: Ideal candidates are NICU infants aged 37 weeks or older who are not taking full oral feeds and have been diagnosed with feeding difficulties.
Not a fit: Patients with potentially lethal chromosomal anomalies, craniofacial malformations, or foregut malformations may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce the need for chronic tube feeding in infants with feeding disorders.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving feeding outcomes in infants with feeding disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * NICU infant ≥37 weeks postmenstrual age not taking full oral feeds * Consult to Neonatal \& Infant Feeding Disorder Program for oral feeding difficulty with diagnostic manometry ordered * Presence of peristaltic and sphincteric reflexes at initial manometry Exclusion Criteria: * Potentially lethal chromosomal anomalies * Craniofacial malformations * Foregut malformations
Where this trial is running
Columbus, Ohio
- Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Sudarshan Jadcherla — Nationwide Children's Hospital
- Study coordinator: Erika K Osborn
- Email: erika.osborn@nationwidechildrens.org
- Phone: 6143556667
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.