Novel PIONEER© Protocol: RCT

Starting soon · Not applicable

Conditions studied: Deglutition Disorders in Infants, Chronic Tube Feeding in Hospitalized Infants

In brief

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.

Key facts

Study ID

NCT07035912

Run by

Nationwide Children's Hospital

People needed

134

Starts

2026-07-01

Expected to finish

2032-06-30

Last updated by the study team

2026-01-16

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

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

Full record on ClinicalTrials.gov

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