Cardiac Surgery Recovery in Infants Assessed Using Neoneur Feeding System

Not Applicable

Not yet recruiting

• Conditions: Post-Surgical Complication; Neonatal Disease; Cardiac Disease
• Interventions: Device: Neoneur Feeding System

• Registration Number: NCT06569641
• Lead Sponsor: Neoneur LLC

Brief Summary

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.

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 Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-21
• Last Update Submitted: 2024-08-21
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26
• Study Start: 2024-09
• Primary Completion: 2025-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Feeding Assessment	Neoneur Feeding System	While Feeding, use Neoneur Feeding System to measure feeding patterns (suck, swallow, and breathing)

Primary Outcome Measures

Name	Time	Method
To test the validity in use of feeding parameters to measure recovery progress for infants with complex CHD	12 months	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.

Secondary Outcome Measures

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