Deglutition Disorders in InfantsPIONEERNCT07035912
Parent Implemented Oral Nutrition, Eating, and Esophageal Reflexes Reintegration Protocol: RCT
A study testing PIONEER Protocol in people with Deglutition Disorders in Infants and Chronic Tube Feeding in Hospitalized Infants, run by Nationwide Children's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 week to 6 months
- Conditions the study is for
- Deglutition Disorders in Infants, Chronic Tube Feeding in Hospitalized Infants
- What is being tested?
- PIONEER Protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2027to 30 Jun 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Parent-Implemented Oral Nutrition, Eating, and Esophageal Reflexes Reintegration Program Using Novel Aerodigestive Stimulation in Gastrostomy Risk Infants: RCT on Clinical and Mechanistic Outcomes
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.
Read the detailed description
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.
- Being tested
- PIONEER Protocol
- Keywords
- Neonatal, Deglutition Disorders, NICU infants, Gastrostomy prevention, Chronic tube feeding
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIONEER ProtocolCombination 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: after 4 weeks or prior to discharge if sooner
Secondary outcomes (8)
Change in feeding volume at discharge
will measure the % of oral feeds prior to initial study and at discharge
Measured: 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.
Measured: at discharge
Growth
Compare weight, length and head circumference growth between groups until 1 year corrected age between the control and the intervention group.
Measured: until 1 year corrected age
Neurodevelopment
compare available Bayley scores obtained from electronic medical records between the control and the intervention group .
Measured: 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.
Measured: until 1 year corrected age
Pulmonary support at discharge
Compare the respiratory support at discharge between the control and the intervention group
Measured: 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
Measured: 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.
Measured: At four weeks or discharge whichever is sooner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Jul 2027 (estimated)
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition Disorders in InfantsStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Qualifying consented subjects will be randomized to standard feeding management with cue based feeds (Control) or the PIONEER protocol (Intervention).
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sudarshan Jadcherla, Nationwide Children's Hospital
- Investigators
- Sudarshan Jadcherla, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035912
- Sponsor's protocol ID
- STUDY00004923
- Acronym
- PIONEER
- Status last verified
- Aug 2026
- First submitted
- 9 Apr 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-Implemented Oral Nutrition, Eating, and Esophageal Reflexes Reintegration Program Using Novel Aerodigestive Stimulation in Gastrostomy Risk Infants: RCT on Clinical and Mechanistic Outcomes
- ClinicalTrials.gov ID
- NCT07035912
- Acronym / sponsor ID
- PIONEER / STUDY00004923
- Keywords
- Neonatal, Deglutition Disorders, NICU infants, Gastrostomy prevention, Chronic tube feeding
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Qualifying consented subjects will be randomized to standard feeding management with cue based feeds (Control) or the PIONEER protocol (Intervention).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: PIONEER Protocol | Experimental | Combination Product: PIONEER ProtocolPIONEER 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 |
| Control Group: Standard of care treatment | No intervention | –Standard feeding management per primary care team: -Cue based po feeds per the unit protocol |
Who may qualify
- Ages
- 1 week to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Combination product | Intervention Group: PIONEER Protocol |
Primary outcome
Improvement in oral feeding and absence of gastrostomy tube
Time frame: improvement in feeding from prior to initial study to 4 weeks or discharge if sooner, gastrostomy tube at discharge
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
Compare the change in mechanistic biomarkers between the groups
Time frame: after 4 weeks or prior to discharge if sooner
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.
8 secondary outcomes
Change in feeding volume at discharge
Time frame: at discharge
Length of hospital stay (LOHS) and postmenstrual age (PMA) at discharge
Time frame: at discharge
Growth
Time frame: until 1 year corrected age
Neurodevelopment
Time frame: at 18-26 months corrected age
Longterm Feeding Outcomes
Time frame: until 1 year corrected age
Pulmonary support at discharge
Time frame: at discharge
Parent satisfaction and stress level
Time frame: at 4 weeks or discharge, whichever is sooner
Compare the change in mechanistic biomarkers within the groups
Time frame: At four weeks or discharge whichever is sooner
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sudarshan Jadcherla principal investigator
Nationwide Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing PIONEER Protocol in people with Deglutition Disorders in Infants and Chronic Tube Feeding in Hospitalized Infants, run by Nationwide Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erika K Osborn (6143556667, erika.osborn@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in oral feeding and absence of gastrostomy tube (time frame: improvement in feeding from prior to initial study to 4 weeks or discharge if sooner, gastrostomy tube at discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.