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Parent Implemented Oral Nutrition, Eating, and Esophageal Reflexes Reintegration Protocol: RCT
Sponsor: Nationwide Children's Hospital
Summary
Feeding dysfunction remains a major unmet challenge among neonatal ICU survivors, frequently leading to prolonged tube feeding or gastrostomy at discharge, increased healthcare utilization, substantial socioeconomic burden, and adverse neurodevelopmental outcomes. This randomized controlled trial will evaluate the innovative Parent-Implemented Oral Nutrition, Eating, and Esophageal Reflexes Reintegration (PIONEER) protocol to advance understanding of swallowing physiology and establish a safe, effective, family-centered feeding intervention. Successful completion of this study has the potential to reduce gastrostomy dependence, improve long-term health and quality of life, and transform standards of neonatal feeding care in alignment with NIH missions and priorities.
Official title: Parent-Implemented Oral Nutrition, Eating, and Esophageal Reflexes Reintegration Program Using Novel Aerodigestive Stimulation in Gastrostomy Risk Infants: RCT on Clinical and Mechanistic Outcomes
Key Details
Gender
All
Age Range
1 Week - 6 Months
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2027-07-01
Completion Date
2032-06-30
Last Updated
2026-08-28
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