Cardiac Surgery Recovery in Infants Assessed Using Neoneur Feeding System

A prospective non-randomized longitudinal design of 30-40 infants from initiation of oral feeding until discharge to track feeding changes as a potential indicator of surgical recovery.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Disease; Neonatal Disease; Post-Surgical Complication
• Intervention / Treatment: Device: Neoneur Feeding System

Detailed Description

Safe oral feeding is a challenge for infants born with complex congenital heart disease (CHD). These infants are likely to require tube-assisted feeding at the initiation of enteral feeding and struggle to transition to full oral feeding. Infant post-surgery recovery includes a safe transition to oral feeding without respiratory risk. Neoneur Feeding System, consists of a novel hand-held, mobile phone application, and a cloud based computation, which innovatively measures patterns of oral cavity pressure synchronized with respiration, providing a quantitative assessment of feeding patterns. Yet there has been no quantitative means of measuring this recovery process. The concept of post-surgical recovery model is not new. The adult literature is replete with physiologic and behavioral indicators of recovery. More recently Roy and colleagues introduced a recovery model for post-surgical CHD children to adults using a component metrics of physiologic parameters. We are proposing to develop an infant specific recovery model using feeding patterns using data generated by the Neoneur device. The model, using the lens of behavioral organization, will include feeding measurements from initiation of oral feeding to discharge.

This study will evaluate the association between feeding recovery and clinical assessment of infant behaviors as measured in a brief survey to assess irritability, ability to be soothed, alertness, non-nutritive sucking, and muscle tone. Forty infants will be recruited from the PCICU-CSD at MUSC to capture thirty usable infant sets of Neoneur data from the PCICU-CSD at MUSC. This data will be assessed using the Neoneur Feeding System to create a model of feeding recovery.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Complex congenital heart disease requiring cardiac surgery during first month of life
• Gestational age>=35 weeks at birth

Exclusion Criteria:

• No other major non-cardiac congenital anomalies,
• No history of major neurologic insult
• Not listed for a heart transplant,
• Not intubated for >4 weeks post-surgery,
• Not trisomy 13, 18, and 21
• No cleft lip/palate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• 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; While Feeding, use Neoneur Feeding System to measure feeding patterns (suck, swallow, and breathing)	Device: Neoneur Feeding System; The Neoneur Feeding System is placed between a nipple and a bottle, and used to measure feeding skill patterns.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To test the validity in use of feeding parameters to measure recovery progress for infants with complex CHD	A comparison of feeding patterns (oral cavity pressure changes in suck and swallow, and respiratory patterns) and changes as an infant recovers and determination if there is a greater than 60% concordance with behavioral survey measuring recovery.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Neoneur Feeding system measurements seen in post surgical infants, to match clinical observation of suck, swallow, and breathing during oral feeding.	70% concordance between Neoneur Feeding Trace, and clinical observation	12 months

Collaborators and Investigators

• Sponsor: Neoneur LLC

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Recovery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Infant, Newborn, Diseases
• Other Study ID Numbers: C03101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All Protocol, Inform Consent, and Final data will be shared with the research sites for their use in publications, and as required by the NIH.

Drug and device information, study documents

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