Cardiac Surgery Recovery in Infants Assessed Using Neoneur Feeding System

Not Applicable

Not yet recruiting

• Conditions: Neonatal Disease; Post-Surgical Complication; Cardiac Disease

• Registration Number: NCT06569641
• Lead Sponsor: Neoneur LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Inclusion Criteria:<br><br> - Complex congenital heart disease requiring cardiac surgery during first month of<br> life<br><br> - Gestational age>=35 weeks at birth<br><br>Exclusion Criteria:<br><br> - No other major non-cardiac congenital anomalies,<br><br> - No history of major neurologic insult<br><br> - Not listed for a heart transplant,<br><br> - Not intubated for >4 weeks post-surgery,<br><br> - Not trisomy 13, 18, and 21<br><br> - No cleft lip/palate.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

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.