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:

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dysphagia of Newborn

• Study Type: Observational
• Enrollment (Actual): 60

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

• United States
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 3 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy newborns and neonates with CHD

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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	1 year
Type and quality of oral motor skills of infants with CHD before cardiothoracic surgery as measured by NOMAS	1 year
Type and quality of feeding readiness using the Infant Driven Feeding Scales with infants with CHD after cardiothoracic surgery	1 year
Type and Quality of oral motor skills in newborn infants as measured by NOMAS	1 year
Type and quality of oral motor skills of infants with CHD after cardiothoracic surgery as measured by NOMAS	1 year

Collaborators and Investigators

• Sponsor: Advocate Health Care
• Investigators: Principal Investigator: Jennifer L Fogel, MSCCC-SLP/L, Advocate Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: January 26, 2017
• First Submitted That Met QC Criteria: February 4, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 6540; K5900376 (Other Identifier: Advocate Health Care)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No