Parent Implemented Oral Nutrition, Eating, and Esophageal Reflexes Reintegration Protocol: RCT

Overview

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.

Survival of neonatal intensive care unit (NICU) infants has improved substantially; however, chronic tube feeding, aerodigestive, and neurodevelopmental morbidities continue to rise. Disorders of Deglutition, characterized by impaired feeding and swallowing function, contribute to poor nutrition, impaired growth, prolonged hospitalization, adverse neurodevelopmental outcomes, and increased reliance on gastrostomy tube (G-tube) feeding. Effective, evidence-based interventions that promote oral feeding competence during critical develop-mental periods are urgently needed to reduce chronic tube feeding and its associated health and socioeconomic burdens. The long-term goal of this research is to improve feeding, aerodigestive and developmental outcomes in high-risk NICU infants through biologically informed interventions. The objective of this application is to determine the efficacy and mechanisms of the Parent-Implemented Oral Nutrition, Eating, and Esophageal Reflexes Reintegration (PIONEER) protocol using feeding and aerodigestive stimulation therapy for infants at risk for G-tube placement. Safety, feasibility, and preliminary efficacy of the intervention have been established. The central hypothesis is that targeted stimulation of aerodigestive reflex pathways during critical develop-mental windows promotes adaptive maturation of feeding-related neural and sensorimotor networks, resulting in improved aerodigestive reflex function, enhanced oral feeding competence, and reduced G-tube need. This hypothesis will be tested in a randomized controlled trial comparing the PIONEER protocol with standard care. Aim 1: Determine the efficacy of PIONEER Protocol in improving oral feeding outcomes and reducing G-tube placement. Primary outcome will be met with improvement in oral feeding by 4 weeks and avoidance of G-tube at discharge. We hypothesize that more infants randomized to the PIONEER protocol will have improvement in oral intakes and avoidance of G-tubes at discharge versus infants receiving standard care. Aim 2: Define the mechanistic biomarkers associated with intervention response. We will test the hypothesis that the PIONEER protocol enhances sensory-motor integration and normalizes aerodigestive reflex function compared with standard care. We will perform longitudinal HRPEM studies to identify treatment-related changes in physiological biomarkers and determine the mechanistic basis of improved feeding outcomes. Primary outcome: change in HRPEM-derived aerodigestive biomarkers from baseline to final study assessment. The expected outcomes and impact of this project are: (1) validation of an effective parent-implemented intervention for infants at risk for chronic tube feeding; (2) identification of mechanistic biomarkers linking physio-logical adaptations to clinically meaningful feeding outcomes; and (3) establishment of a scalable, evidence-based therapy to improve feeding safety, feeding efficiency, growth, and developmental outcomes. Successful completion of this project is expected to reduce G-tube dependence, shorten NICU hospitalization, improve quality of life for infants and families, and lessen the substantial public health burden associated with feeding disorders.