Novel PIONEER© Protocol: RCT

NCT ID: NCT07035912

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-07-01
• Study Completion Date: 2032-06-30

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.

Detailed Description

Survival rates after neonatal ICU (NICU) care are increasing along with the prevalence of Disorders of Deglutition (DD) among these survivors. DD includes impairments in eating, dysfunctional swallowing, and aerodigestive symptoms which lead to chronic nutritional-, growth- and neurodevelopmental issues. Early, effective, and simple crib-side diagnostic methods and therapies that normalize feeding difficulties during critical development periods are needed to avoid reliance on chronic nasogastric (NG) or gastrostomy tube (g-tube) feeding. These critical diagnostic and rehabilitative challenges are addressed through a randomized controlled trial (RCT) to improve aerodigestive and neurodevelopmental milestones in infants at risk for g-tube use, ultimately reducing public health burden throughout the child's life, which is the long-term goal.

The overarching aim is to implement the Parent-Implemented Oral Nutrition, Eating- and Esophageal rhythms Reintegration (PIONEER) program initiatives to examine the Jadcherla hypothesis. The Jadcherla Hypothesis states that engaging the enteric and central nervous system reflexes early, persistently, and safely in tube-fed infants will result in consistent programmed activation of the deglutition process, swallowing-airway interactions, peristaltic reflexes, and autonomic regulation that will advance neuroplasticity, learning and memory.

The central hypothesis is that the activatable aerodigestive reflex mechanisms are vital in managing oral eating skills, and the independent feeding outcomes (i.e., without a G-tube) depend on intervention strategies.

The rationale is that identifying successful outcomes that are scientifically driven will lay the foundation for scalable protocols. In this RCT, the effect of Parent Implemented Oral Nutrition, Eating, Esophageal reflexes Reintegration (PIONEER©) protocol on clinical and mechanistic outcomes will be examined. Therefore, the impact of the PIONEER© protocol will be tested against the standard of care by completing two specific aims: 1) Compare the efficacy of the randomized intervention by examining the hypothesis that the PIONEER© approach is more effective at achieving the primary outcome of successful oral feeding without requiring a G-tube at NICU discharge. 2) Determine and compare the longitudinal pathophysiological mechanisms in assessing the superiority in achieving the primary outcome by testing the hypothesis that infants who follow the PIONEER© protocol will have more effective mechanisms for restoring and adapting their aerodigestive reflexes.

High-resolution manometry will be used to identify differences between the two study arms concerning the sensory-motor characteristics of aerodigestive reflexes.Completion of the proposed aims will provide opportunities for scalable and generalizable approaches to improve feeding safety and efficiency, while helping infants achieve essential developmental milestones and reducing the socioeconomic burden.

RELEVANCE: This proposal addresses a critical gap for infants who require chronic tube feeding. Completing the proposed aims will result in paradigm shifting methods to optimize oral intake while decreasing the duration of chronic NG tube feeding or preventing g-tube feeding. New evidence-based standardized guidelines will emerge from this study that have the potential for scalability, improving infant feeding-intake methods, growth, and maturation, thereby, alleviating chronic eating difficulties, delayed neurodevelopmental consequences, and public health burden.

Conditions

Deglutition Disorders in Infants; Chronic Tube Feeding in Hospitalized Infants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group: PIONEER Protocol

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

Group Type: EXPERIMENTAL

PIONEER Protocol

Intervention Type: 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

Control Group: Standard of care treatment

Standard of care feeding:

Cue based po feeds done per the unit protocol

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. Nasogastric tube fed infants referred for diagnostic manometry and Gastrostomy tube planning evaluations.

2. Physiologically stable convalescing infants on full enteral feeds at greater than or equal to 37.0 weeks and less than 46 weeks postmenstrual age.

3. Presence of aerodigestive reflexes on diagnostic manometry.

Exclusion Criteria

1. Potentially lethal congenital or chromosomal anomalies

2. Craniofacial defects (cleft lip or palate)

3. History of GI surgery, ENT surgery, or neurosurgery

4. Need for supplemental respiratory support of >2 LPM

• Minimum Eligible Age: 1 Week
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nationwide Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sudarshan Jadcherla

Physician - Neonatology Central Campus

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sudarshan Jadcherla

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Central Contacts

Erika K Osborn

Role: CONTACT

erika.osborn@nationwidechildrens.org

6143556667

Patty Luzader

Role: CONTACT

patty.luzader@nationwidechildrens.org

6143556697

Other Identifiers

STUDY00004923

Identifier Type: -

Identifier Source: org_study_id