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
1 other identifier
interventional
134
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2026
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2025
CompletedFirst Posted
Study publicly available on registry
June 25, 2025
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2031
Study Completion
Last participant's last visit for all outcomes
June 30, 2032
January 16, 2026
January 1, 2026
5 years
April 9, 2025
January 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Presence or Absence of Gastrostomy Tube
Primary outcome is successful oral feeding without G-tube measured at the Primary Endpoint of discharge. This determination allows us to test the effect of interventions during a 4 week-period, continued residual effects after 4 weeks, and parental comfort with the collaborative decision of feeding method at discharge.
around 4 weeks after initial diagnostic study or until discharge (can be sooner)
Change in Aerodigestive Reflexes
Primary outcome is the change in the recruitment of sensory-motor characteristics, and magnitude of aerodigestive reflexes at rest and upon stimulation that are assessed at the repeat manometry study at \~4 weeks, and compared among and between the two arms, testing the effects of intervention protocol.
around 4 weeks after initial diagnostic study
Secondary Outcomes (5)
Parent reported stress and comfort level
up to 1 year
Length of Hospital Stay
at discharge
Growth Metrics
until 1 year corrected age
Neurodevelopment
1-2 years
Longterm Feeding Outcomes
until 1 year corrected age
Study Arms (2)
Intervention Group: PIONEER Protocol
EXPERIMENTALPIONEER© 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
Control Group: Standard of care treatment
NO INTERVENTIONStandard of care feeding: Cue based po feeds done per the unit protocol
Interventions
* 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
Eligibility Criteria
You may qualify if:
- Nasogastric tube fed infants referred for diagnostic manometry and Gastrostomy tube planning evaluations.
- Physiologically stable convalescing infants on full enteral feeds at greater than or equal to 37.0 weeks and less than 46 weeks postmenstrual age.
- Presence of aerodigestive reflexes on diagnostic manometry.
You may not qualify if:
- Potentially lethal congenital or chromosomal anomalies
- Craniofacial defects (cleft lip or palate)
- History of GI surgery, ENT surgery, or neurosurgery
- Need for supplemental respiratory support of \>2 LPM
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sudarshan Jadcherla
Nationwide Children's Hospital
Central Study Contacts
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
Study Record Dates
First Submitted
April 9, 2025
First Posted
June 25, 2025
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
June 30, 2031
Study Completion (Estimated)
June 30, 2032
Last Updated
January 16, 2026
Record last verified: 2026-01
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 the NIDDK central data repository per their access requirements.
* To ensure the privacy of infant participants, we will only preserve and share de-identified data in compliance with ethical and legal guidelines, including the 1996 HIPAA regulations. This data will be available to researchers through the NIDDK central data repository. The information shared will include demographic details, medical history, daily feeding data, outcome data, and manometry data, all of which will be verified before sharing. * Raw data of manometry tracings with videos of individual subjects will not be shared to limit the risk to participant privacy. They will be stored in password-protected files at Nationwide Children's Hospital.