- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03045757
Evaluating Dysphagia in Neonates With CHD
Evaluating Oral Motor Skills of Neonates Requiring Congenital Heart Surgery and the Impact on Oral Feeding Readiness
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:
- Describe the oral motor skills of infants with CHD before surgery as compared with normal full-term newborn (>37 weeks) using the NOMAS
- Describe the oral motor skills of infants with CHD after surgery as compared with those same infants before surgery using the NOMAS.
- 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)
- 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Jennifer L Fogel, MSCCCSLP/L
- Phone Number: 708-684-1357
- Email: jennifer.fogel@advocatehealth.com
Study Contact Backup
- Name: Cheryl A Lefaiver, PhD,RN
- Phone Number: 708-684-4210
- Email: cheryl.lefaiver@advocatehealth.com
Study Locations
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Illinois
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Oak Lawn, Illinois, United States, 60453
- Advocate Children's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Full-term newborns with normal physical exam that are delivered > 37 weeks gestation (healthy newborn arm).
or
- Newborn with CHD born > 37 weeks gestation, are hemodynamically stable and who require surgical correction in the first 30 days of life (CHD arm).
Exclusion Criteria:
- Full-term newborn arm
- Newborn admitted into the NICU
- Genetic syndromes
Congenital abnormalities or signs of developmental delay
· Infants with CHD arm
- Newborn requiring intubation prior to evaluation (Note: Infants with CHD with genetic or other malformations not specifically mentioned will not be excluded due to their prevalence in this population)
- Down Syndrome
- Trisomy 13, Trisomy 18
- Congenital anomalies of facial structure or musculature specifically cleft lip, hard or soft palate
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Healthy Newborn
|
CHD Neonates
Neonates born with CHD before and after surgical repair
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Oral motor skills of infants with CHD utilizing the NOMAS
Time Frame: 1 year
|
1 year
|
Type and quality of oral motor skills of infants with CHD before cardiothoracic surgery as measured by NOMAS
Time Frame: 1 year
|
1 year
|
Type and quality of feeding readiness using the Infant Driven Feeding Scales with infants with CHD after cardiothoracic surgery
Time Frame: 1 year
|
1 year
|
Type and Quality of oral motor skills in newborn infants as measured by NOMAS
Time Frame: 1 year
|
1 year
|
Type and quality of oral motor skills of infants with CHD after cardiothoracic surgery as measured by NOMAS
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jennifer L Fogel, MSCCC-SLP/L, Advocate Healthcare
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6540
- K5900376 (Other Identifier: Advocate Health Care)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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