Neoneur Feeding System Functionality in the Clinic

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Other: Feeding Evaluation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 10 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feeding Assessment<br>Feeding assessment of High-risk premature infants | Other: Feeding Evaluation<br>* Feeding Evaluation with Device<br>* Other names: Neoneur 200;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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