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Novel PIONEER© Protocol: RCT

NCT07035912 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2026-01-16

No results posted yet for this study

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.

Conditions

  • Deglutition Disorders in Infants
  • Chronic Tube Feeding in Hospitalized Infants

Interventions

COMBINATION_PRODUCT

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

Sponsors & Collaborators

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Sudarshan Jadcherla · Nationwide Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Week
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2031-06-30
Completion
2032-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07035912 on ClinicalTrials.gov