Cardiac Surgery Recovery in Infants Assessed Using Neoneur Feeding System
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-50
SponsorNeoneur LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Complex congenital heart disease requiring cardiac surgery during first month of life
Gestational age>=35 weeks at birth
Disqualifiers
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,
Trial design
Design model
Single group
Treatments tested in this trial
Neoneur Feeding System
DeviceThe Neoneur Feeding System is placed between a nipple and a bottle, and used to measure feeding skill patterns.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Feeding AssessmentExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
12 monthsSecondary 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.
70% concordance between Neoneur Feeding Trace, and clinical observation
Time frame
12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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