Evaluating Dysphagia in Neonates With CHD

Dysphagia of Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03045757
• Other study ID #: 6540
• Secondary ID: K5900376
• Status: Active, not recruiting
• Start date: February 1, 2017
• Est. completion date: January 1, 2024

Study information

• Verified date: March 2023
• Source: Advocate Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: January 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia of Newborn

Locations

Country	Name	City	State
United States	Advocate Children's Hospital	Oak Lawn	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Advocate Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral motor skills of infants with CHD utilizing the NOMAS		1 year
Primary	Type and quality of oral motor skills of infants with CHD before cardiothoracic surgery as measured by NOMAS		1 year
Primary	Type and quality of feeding readiness using the Infant Driven Feeding Scales with infants with CHD after cardiothoracic surgery		1 year
Primary	Type and Quality of oral motor skills in newborn infants as measured by NOMAS		1 year
Primary	Type and quality of oral motor skills of infants with CHD after cardiothoracic surgery as measured by NOMAS		1 year