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Novel PIONEER© Protocol: RCT
Sponsor: Nationwide Children's Hospital
Summary
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.
Official title: Randomized Controlled Trial Evaluating the Impact of a Novel Parent Implemented Oral Nutrition, Eating, and Esophageal Reflexes Reintegration Program on Hospitalized Infants With Feeding Challenges
Key Details
Gender
All
Age Range
1 Week - 6 Months
Study Type
INTERVENTIONAL
Enrollment
134
Start Date
2026-07-01
Completion Date
2032-06-30
Last Updated
2026-01-16
Healthy Volunteers
No
Interventions
PIONEER Protocol
* Oral nutritive stimulus with every feed (minimum 5mL) * Esophageal stimulation with up to 15 stimulations given at least 5 times per week with stimulation catheter * High resolution esophageal manometry as much as weekly if feasible throughout protocol * Parent biofeedback (during manometry studies) and education on at least a weekly basis with focus on their participation in oral feeding