Novel PIONEER© Protocol: RCT

Neonatal ICU survivors often face challenges with oral eating, swallowing difficulties, and various aerodigestive issues, and commonly need chronic nasogastric tube feeding or gastrostomy feeding, which escalates socioeconomic burdens, hospital stays, neurodevelopmental delays, and parental suffering. This proposal addresses a vital need in neonatal gastroenterology by studying unique swallowing mechanisms and defining the basis for preventative and corrective therapies through new translational research initiatives via a randomized controlled trial using the novel intervention initiative- Parent Implemented Oral Nutrition, Eating, and Esophageal reflexes Reintegration (PIONEER©) protocol.

NCT Number	NCT07035912
Lead Sponsor	Nationwide Children's Hospital
Conditions	Deglutition Disorders in Infants, Chronic Tube Feeding in Hospitalized Infants
Enrollment	134 participants
Start Date	2026-07-01
Primary Completion	2031-06-30 (estimated)
Study Completion	2032-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-16