Cardiac Surgery Recovery in Infants Assessed Using Neoneur Feeding System

NCT06569641 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: C03101
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neonatal Disease; Post-Surgical Complication; Cardiac Disease

Keywords

Recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Feeding Assessment

EXPERIMENTAL

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

Device: Neoneur Feeding System

Interventions

Neoneur Feeding System DEVICE

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

Feeding Assessment

Eligibility Criteria

• Age: 1 Day - 50 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neoneur LLC: lead

MeSH Terms

Conditions

Infant, Newborn, Diseases; Heart Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Infant feeding patterns during standard care. The Neoneur Feeding System captures data such the changes in these feeding patterns can be measured. This study is capturing longitudinal changes over a short period of time, to see if they reflect infant recovery from surgery.

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 26, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share