Cardiac Surgery Recovery in Infants Assessed Using Neoneur Feeding System

NCT ID: NCT06569641

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2026-09-30

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.

Conditions

Neonatal Disease; Post-Surgical Complication; Cardiac Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Feeding Assessment

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

Group Type: EXPERIMENTAL

Neoneur Feeding System

Intervention Type: DEVICE

The Neoneur Feeding System is placed between a nipple and a bottle, and used to measure feeding skill patterns.

Interventions

Neoneur Feeding System

The Neoneur Feeding System is placed between a nipple and a bottle, and used to measure feeding skill patterns.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 50 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neoneur LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

C03101

Identifier Type: -

Identifier Source: org_study_id