Neoneur Feeding System Functionality in the Clinic (NN200)

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

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

Study Overview

• Status: Recruiting
• Conditions: Feeding Patterns; Feeding; Difficult, Newborn; Feeding Disorder Neonatal
• Intervention / Treatment: Other: Feeding Evaluation

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline Hoedemaker, BS/MBA; Phone Number: 9084004096; Email: choedemaker@neoneur.com
• Study Contact Backup: Name: Karen Heart; Email: choedemaker-pi@neoneur.com

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 08534
      • Recruiting
      • Children's Hospital of Philadelphia
      • Contact: Barbara Medoff-Cooper, PhD MSN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 months (Child)
• Accepts Healthy Volunteers: No

Study Population

High risk neonatal infants in Level IV NICU or CICU

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Feeding Assessment; Feeding assessment of High-risk premature infants	Other: Feeding Evaluation; Feeding Evaluation with Device; Other Names: Neoneur 200

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory	The evaluation of Neoneur 200's respiratory sensor to collect accurate data	6 months

Collaborators and Investigators

• Sponsor: Neoneur LLC
• Collaborators: Children's Hospital of Philadelphia; National Institute of Nursing Research (NINR); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Barbara Medoff-Cooper, MSN, PhD, Children's Hospital of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2022
• Primary Completion (Estimated): August 14, 2024
• Study Completion (Estimated): September 14, 2024

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Feeding and Eating Disorders
• Other Study ID Numbers: NN2022-01; 1R44NR020275-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: the results will be available and we will seek publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No