An interventional study of PIONEER Protocol in Deglutition Disorders in Infants and Chronic Tube Feeding in Hospitalized Infants, sponsored by Nationwide Children's Hospital. Not yet recruiting. Open to participants aged 1 Week to 6 Months. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Nationwide Children's Hospital · Not applicable, Interventional, and Treatment
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.
871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.
This study's planned enrollment of 130 is above the median of 60 across 578 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →Nationwide Children's Hospital is the lead sponsor of 233 studies on the registry; 43 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 9 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
EXCLUSION CRITERIA
PIONEER Protocol * Nutritive oral stim with each feed (at least 5mL) * Esophageal stimulation at least 3 times per week * Weekly high resolution pharyngoesophageal manometry with esophageal stimulation * Parent biofeedback/oral feeding participation
Combination Product: PIONEER Protocol
Standard feeding management per primary care team: -Cue based po feeds per the unit 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
Improvement in oral feeding and absence of gastrostomy tube
Will compare successful outcomes of improvement in oral feeding at 4 weeks and absence of gastrostomy at discharge between the control and the intervention group
Time frame: improvement in feeding from prior to initial study to 4 weeks or discharge if sooner, gastrostomy tube at discharge
Compare the change in mechanistic biomarkers between the groups
Will measure the difference in longitudinal change in aerodigestive biomarkers from initial to final HRPEM between the groups from the initial to the final high resolution pharyngoesophageal manometry.
Time frame: after 4 weeks or prior to discharge if sooner
Change in feeding volume at discharge
will measure the % of oral feeds prior to initial study and at discharge
Time frame: at discharge
Length of hospital stay (LOHS) and postmenstrual age (PMA) at discharge
Compare the LOHS and PMA at discharge between the control and the intervention group.
Time frame: at discharge
Growth
Compare weight, length and head circumference growth between groups until 1 year corrected age between the control and the intervention group.
Time frame: until 1 year corrected age
Neurodevelopment
compare available Bayley scores obtained from electronic medical records between the control and the intervention group .
Time frame: at 18-26 months corrected age
Longterm Feeding Outcomes
Compare feeding method during the first year of life between the control and the intervention group.
Time frame: until 1 year corrected age
Pulmonary support at discharge
Compare the respiratory support at discharge between the control and the intervention group
Time frame: at discharge
Parent satisfaction and stress level
Will compare parent surveys done prior to initial study and after final study between the control and the intervention group
Time frame: at 4 weeks or discharge, whichever is sooner
Compare the change in mechanistic biomarkers within the groups
To compare the longitudinal change in esophageal and sphincteric length and region-specific contractile and relaxation integrals (mmHg.cm.sec) amongst feeding success and failure within and between groups.
Time frame: At four weeks or discharge whichever is sooner
No study locations are listed for this record.
Plan to share: Yes — Deidentified data (perinatal, growth and nutrition, comorbidities, respiratory, clinical outcomes and results of pharyngoesophageal manometry analysis) will be stored in one of the NIH repositories, likely either the NIDDK Central Repository (NIDDK-CR R4R) or the NICHD Data and Specimen Hub (DASH).
Supporting information: Clinical study report
Time frame: Data will be shared after completion of study
Access criteria: This data will be available to researchers through a NIH central data repository per their access requirements.
No publications or documents are linked to this record.
Start is estimated for Jul 2027; primary completion for Jun 2031, 47 months later.
Of 288 non-industry interventional studies with no phase under Deglutition Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's planned 47 months is above that.
Counting every sponsor, half of 297 studies reached it within 21 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nationwide Children's Hospital →