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

NCT07035912 | Not Yet Recruiting DMC

• 1 other identifier: STUDY00004923
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Deglutition Disorders in Infants; Chronic Tube Feeding in Hospitalized Infants

Keywords

Neonatal; Deglutition Disorders; NICU infants; Gastrostomy prevention; Chronic tube feeding

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  after 4 weeks or prior to discharge if sooner

Secondary Outcomes (8)

• Change in feeding volume at discharge

  at discharge

• Length of hospital stay (LOHS) and postmenstrual age (PMA) at discharge

  at discharge

• Growth

  until 1 year corrected age

• Neurodevelopment

  at 18-26 months corrected age

• Longterm Feeding Outcomes

  until 1 year corrected age

Study Arms (2)

Intervention Group: PIONEER Protocol

EXPERIMENTAL

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

Control Group: Standard of care treatment

NO INTERVENTION

Standard feeding management per primary care team: -Cue based po feeds per the unit protocol

Interventions

PIONEER Protocol COMBINATION_PRODUCT

* 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

Intervention Group: PIONEER Protocol

Eligibility Criteria

• Age: 1 Week - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Nasogastric tube fed infants on full enteral feeds
• ≥37 and ≤46 weeks postmenstrual age at initial study
• Presence of aerodigestive reflexes on initial pharyngoesophageal manometry.

You may not qualify if:

• Potentially lethal congenital or chromosomal anomalies
• Severe Neuropathology
• Craniofacial defects (cleft lip or palate)
• History of GI surgery, ENT surgery, or neurosurgery
• Need for supplemental respiratory support of \>2 LPM

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Sudarshan Jadcherla

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erika K Osborn

CONTACT

6143556667; erika.osborn@nationwidechildrens.org

Patty Luzader

CONTACT

6143556697; patty.luzader@nationwidechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician - Neonatology Central Campus

Model Details: Qualifying consented subjects will be randomized to standard feeding management with cue based feeds (Control) or the PIONEER protocol (Intervention).

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: June 25, 2025
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2032
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• 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.