Clinical Trials Directory

Trials / Terminated

TerminatedNCT03045757

Evaluating Dysphagia in Neonates With CHD

Evaluating Oral Motor Skills of Neonates Requiring Congenital Heart Surgery and the Impact on Oral Feeding Readiness

Status
Terminated
Phase
Study type
Observational
Enrollment
60 (actual)
Sponsor
Wake Forest University Health Sciences · Academic / Other
Sex
All
Age
1 Day – 3 Months
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
2017-01-03
Primary completion
2023-10-13
Completion
2023-10-13
First posted
2017-02-07
Last updated
2024-10-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03045757. Inclusion in this directory is not an endorsement.