Novel PIONEER© Protocol: RCT

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorNationwide Children's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • PIONEER Protocol

Treatment groups

134 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators