Evaluating the Impact of a Novel PIONEER Program

Launched by NATIONWIDE CHILDREN'S HOSPITAL · Jun 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new program called PIONEER that aims to help infants who have trouble swallowing and eating by mouth after staying in the neonatal intensive care unit (NICU). Many of these babies need feeding tubes because they struggle with swallowing and related digestive issues, which can lead to longer hospital stays, delays in development, and stress for families. The PIONEER program involves parents in helping their babies improve oral feeding and swallowing reflexes, with the goal of reducing the need for feeding tubes and improving overall feeding skills.

Babies who might be eligible for this study are those between about 7 weeks and 6 months old who are stable and fully fed through a tube, but still require evaluations for feeding tube planning. To join, infants need to show certain swallowing reflexes during testing and must not have serious congenital conditions, cleft lip or palate, previous major surgeries, or need strong breathing support. Participants will be part of a randomized trial, meaning some families will receive the new PIONEER program while others will receive standard care, and researchers will compare the outcomes. This study is not yet recruiting but aims to find better ways to support infants and families facing feeding challenges after NICU care.

Gender

ALL

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