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NCT03045757 · ClinicalTrials.gov registry record
Evaluating Dysphagia in Neonates With CHD
A clinical trial, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- 60
- Enrollment target
NCT03045757: Clinical Trial study, sponsored by Wake Forest University Health Sciences.
NCT03045757 is a clinical trial that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03045757 was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- 60 participants
- Enrollment target
Study Summary
The overall goal of this study is to describe the oral motor skills of neonates born with congenital heart defects, both before and after cardiac surgery, and to evaluate current measures of feeding motor skills and feeding readiness in this population using the Neonatal Oral Motor Assessment Scale (NOMAS) and the Infant Driven Feeding Scale. The specific aims are to: 1. Describe the oral motor skills of infants with CHD before surgery as compared with normal full-term newborn (\>37 weeks) using the NOMAS 2. Describe the oral motor skills of infants with CHD after surgery as compared with those same infants before surgery using the NOMAS. 3. Determine if the current Infant Driven Feeding Readiness Scale appropriately identifies which children with CHD are ready for oral feeding. (A. Feeding Readiness Scale, B. Quality of Nippling Scale at the 1st post- operative feeding evaluation) 4. Describe the unique characteristics of oral motor skills in infants with CHD (ie. Wide jaw excursions, poor latch, etc.) Our hypothesis is that infants with CHD will have dysfunctional sucking patterns before surgical repair as compared to normal newborns. This dysfunctional sucking pattern in infants with CHD will have worsened post-surgery as compared to pre-surgery. In addition, the Infant Driven Feeding Scale will be utilized to predict that many infants with CHD will not be ready for oral feedings, however most of those patients will go on to successfully take oral feedings.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2017-01-03 |
| Est. Completion | 2023-10-13 |
Why NCT03045757 stopped before completion
NCT03045757 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03045757 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03045757 about?
NCT03045757 is a clinical study titled "Evaluating Dysphagia in Neonates With CHD". The overall goal of this study is to describe the oral motor skills of neonates born with congenital heart defects, both before and after cardiac surgery, and to evaluate current measures of feeding motor skills and feeding readiness in this population using the Neonatal Oral Motor Assessment Scale ...
What is the current status of trial NCT03045757?
This trial is currently terminated. The enrollment target is 60 participants. The study started on 2017-01-03. Estimated completion is 2023-10-13.
Who is sponsoring clinical trial NCT03045757?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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