Status:

NOT_YET_RECRUITING

Cardiac Surgery Recovery in Infants Assessed Using Neoneur Feeding System

Lead Sponsor:

Neoneur LLC

Conditions:

Neonatal Disease

Post-Surgical Complication

Eligibility:

All Genders

1-50 years

Phase:

NA

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 strugg...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

September 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2026

Estimated Enrollment :

35 Patients enrolled

Trial Details

Trial ID

NCT06569641

Start Date

September 1 2024

End Date

September 1 2026

Last Update

August 26 2024

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