Neoneur Feeding System Functionality in the Clinic

Feeding Patterns Clinical Trial

— NN200  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05525091
• Other study ID #: NN2022-01
• Secondary ID: 1R44NR020275-01
• Status: Recruiting
• Phase: N/A
• Start date: July 14, 2022
• Est. completion date: September 14, 2024

Study information

• Verified date: September 2023
• Source: Neoneur LLC
• Contact: Caroline Hoedemaker, BS/MBA
• Phone: 9084004096
• Email: choedemaker[@]neoneur.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 14, 2024
• Est. primary completion date: August 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 10 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Feeding and Eating Disorders
• Feeding Disorder Neonatal
• Feeding Patterns
• Feeding; Difficult, Newborn

Intervention

Other:
• Feeding Evaluation
Feeding Evaluation with Device

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Neoneur LLC	Children's Hospital of Philadelphia, National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maturation	Neoneur 200 measures are corelated to infant maturation in gestational age	6 weeks of data collection
Primary	Telehealth functionality	Evaluation of Sending Neoneur 200 data from the bedside to the cloud for used in the hospital and home	6 months
Secondary	Respiratory	The evaluation of Neoneur 200's respiratory sensor to collect accurate data	6 months