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NCT07035912

Novel PIONEER© Protocol: RCT

Not yet recruiting NA Last updated 16 January 2026
What this trial tests

NA trial testing PIONEER Protocol in Deglutition Disorders in Infants in 134 participants. Not yet recruiting.

Timeline
1 July 2026
Primary endpoint
30 June 2031
30 June 2032

Quick facts

Lead sponsorNationwide Children's Hospital
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment134
Start date1 July 2026
Primary completion30 June 2031
Estimated completion30 June 2032

Drugs / interventions tested

Conditions studied

Sponsor

Nationwide Children's Hospital

Who can join

Adults 1 Week to 6 Months, any sex, with Deglutition Disorders in Infants or Chronic Tube Feeding in Hospitalized Infants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Nationwide Children's Hospital trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07035912.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing