NCT05525091

Neoneur Feeding System Functionality in the Clinic

Neoneur Feeding System Functionality in the Clinic - Investigating Assessment of Quantifying Feeding Functionality in Premature and Cardiac Surgery Neonates in Comparison to Dr. Medoff-Cooper's Past Research

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Neoneur LLC · Industry
• Sex: All
• Age: 1 Day – 10 Weeks
• Healthy volunteers: Not accepted

Summary

Prospective data collection using the Neoneur Feeding System to demonstrate device functionality, correlation to historic data, and prepare for a more extensive phase II SBIR trial

Detailed description

The consented infant's assigned Speech Language Pathologist will use the Neoneur Feeding System 2-3 times a week from initiation of oral feeding until discharge, if oral feeding is prescribed. It can be used either as a special consult, or during routine care. The feeding is performed by the Speech Language Pathologist assigned to the infant. There will be no change in the infant's feeding plan. For infants consented to participate in the study, their feeding will include the Neoneur feeding system inserted between the nipple and bottle. When the Neoneur is inserted, it will capture both the suck and swallow changes (oral cavity pressure), and respiration (temperature changes) patterns.

Conditions

• Feeding Patterns
• Feeding; Difficult, Newborn
• Feeding Disorder Neonatal

Interventions

Type	Name	Description
OTHER	Feeding Evaluation	Feeding Evaluation with Device

Timeline

• Start date: 2022-07-14
• Primary completion: 2024-08-14
• Completion: 2024-09-14
• First posted: 2022-09-01
• Last updated: 2023-09-15

Locations

1 site across 1 country: United States