Feasibility of a new therapy for feeding disorders in infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Probiotic supplementation for extremely preterm infants in Scandinavia

  This study is testing if giving probiotics mixed with breastmilk can help extremely preterm infants avoid serious gut problems and reduce the risk of dying.

  Recruiting Region Stockholm · Solna, Stockholm County · NCT05604846

• Eating Disorder Dynamic Intervention

  A digital program is tested to help adults with eating disorders by sending real-time, personalized coping tips based on smartphone surveys and sensor data.

  Recruiting Trustees of Dartmouth College · Lebanon, New Hampshire · NCT07600671

• Long-term observation of severe eating disorders

  This study is tracking adolescents and adults with severe eating disorders over many years to see what factors affect their health and recovery.

  Recruiting Uppsala University Hospital · Uppsala · NCT06752304

• New treatment program for adolescents with eating disorders

  This study is testing a new treatment program for teenagers with serious eating disorders to see if it helps them feel better and recover over about 16 to 20 weeks.

  Recruiting Fundació Sant Joan de Déu · Barcelona · NCT06431854

• D-TAP Parental Questionnaire for Early Screening of Pediatric Feeding Disorder in Hospitalized Infants

  This study tests whether the D-TAP parental questionnaire can reliably screen for pediatric feeding disorder in hospitalized children aged 8 to 18 months.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07895914

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.