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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