NCT07035912

Novel PIONEER© Protocol: RCT

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Nationwide Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Week – 6 Months
• Healthy volunteers: Not accepted

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.

Detailed description

Survival rates after neonatal ICU (NICU) care are increasing along with the prevalence of Disorders of Deglutition (DD) among these survivors. DD includes impairments in eating, dysfunctional swallowing, and aerodigestive symptoms which lead to chronic nutritional-, growth- and neurodevelopmental issues. Early, effective, and simple crib-side diagnostic methods and therapies that normalize feeding difficulties during critical development periods are needed to avoid reliance on chronic nasogastric (NG) or gastrostomy tube (g-tube) feeding. These critical diagnostic and rehabilitative challenges are addressed through a randomized controlled trial (RCT) to improve aerodigestive and neurodevelopmental milestones in infants at risk for g-tube use, ultimately reducing public health burden throughout the child's life, which is the long-term goal. The overarching aim is to implement the Parent-Implemented Oral Nutrition, Eating- and Esophageal rhythms Reintegration (PIONEER) program initiatives to examine the Jadcherla hypothesis. The Jadcherla Hypothesis states that engaging the enteric and central nervous system reflexes early, persistently, and safely in tube-fed infants will result in consistent programmed activation of the deglutition process, swallowing-airway interactions, peristaltic reflexes, and autonomic regulation that will advance neuroplasticity, learning and memory. The central hypothesis is that the activatable aerodigestive reflex mechanisms are vital in managing oral eating skills, and the independent feeding outcomes (i.e., without a G-tube) depend on intervention strategies. The rationale is that identifying successful outcomes that are scientifically driven will lay the foundation for scalable protocols. In this RCT, the effect of Parent Implemented Oral Nutrition, Eating, Esophageal reflexes Reintegration (PIONEER©) protocol on clinical and mechanistic outcomes will be examined. Therefore, the impact of the PIONEER© protocol will be tested against the standard of care by completing two specific aims: 1) Compare the efficacy of the randomized intervention by examining the hypothesis that the PIONEER© approach is more effective at achieving the primary outcome of successful oral feeding without requiring a G-tube at NICU discharge. 2) Determine and compare the longitudinal pathophysiological mechanisms in assessing the superiority in achieving the primary outcome by testing the hypothesis that infants who follow the PIONEER© protocol will have more effective mechanisms for restoring and adapting their aerodigestive reflexes. High-resolution manometry will be used to identify differences between the two study arms concerning the sensory-motor characteristics of aerodigestive reflexes.Completion of the proposed aims will provide opportunities for scalable and generalizable approaches to improve feeding safety and efficiency, while helping infants achieve essential developmental milestones and reducing the socioeconomic burden. RELEVANCE: This proposal addresses a critical gap for infants who require chronic tube feeding. Completing the proposed aims will result in paradigm shifting methods to optimize oral intake while decreasing the duration of chronic NG tube feeding or preventing g-tube feeding. New evidence-based standardized guidelines will emerge from this study that have the potential for scalability, improving infant feeding-intake methods, growth, and maturation, thereby, alleviating chronic eating difficulties, delayed neurodevelopmental consequences, and public health burden.

Conditions

• Deglutition Disorders in Infants
• Chronic Tube Feeding in Hospitalized Infants

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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

Timeline

• Start date: 2026-07-01
• Primary completion: 2031-06-30
• Completion: 2032-06-30
• First posted: 2025-06-25
• Last updated: 2026-01-16