Neoneur Feeding System Functionality in the Clinic

Not Applicable

Recruiting

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

• Registration Number: NCT05525091
• Lead Sponsor: Neoneur LLC

Brief 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.

Study Timeline

• Study Start: 2022-07-14
• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-08-30
• Study First Posted: 2022-09-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-15
• Primary Completion: 2024-08-14
• Study Completion: 2024-09-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Preterm infants: requiring tube assisted feeding while in the NICU, gestational age at birth =<34 week, extubated by term
• Infants with CHD: requiring surgery during the first month of life, gestational age > 37 weeks

Exclusion Criteria

• Premature infants: craniofacial anomalies, infants with grade IV intraventricular hemorrhage, apgar < 5 at 5 minutes, short gut syndrome, history of NEC
• Infants with CHD: no other congenital anomalies, no history of major neurologic insult , listed for heart transplant, history of ECMO, intubated for > 4 weeks, requiring additional surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Maturation	6 weeks of data collection	Neoneur 200 measures are corelated to infant maturation in gestational age
Telehealth functionality	6 months	Evaluation of Sending Neoneur 200 data from the bedside to the cloud for used in the hospital and home

Secondary Outcome Measures

Name	Time	Method
Respiratory	6 months	The evaluation of Neoneur 200's respiratory sensor to collect accurate data

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States