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Evaluating Dysphagia in Neonates With CHD

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ClinicalTrials.gov Identifier: NCT03045757
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Jennifer Fogel, Advocate Health Care

Brief 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.

Condition or disease
Dysphagia of Newborn

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluating Oral Motor Skills of Neonates Requiring Congenital Heart Surgery and the Impact on Oral Feeding Readiness
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Healthy Newborn
Healthy Newborn
CHD Neonates
Neonates born with CHD before and after surgical repair



Primary Outcome Measures :
  1. Oral motor skills of infants with CHD utilizing the NOMAS [ Time Frame: 1 year ]
  2. Type and quality of oral motor skills of infants with CHD before cardiothoracic surgery as measured by NOMAS [ Time Frame: 1 year ]
  3. Type and quality of feeding readiness using the Infant Driven Feeding Scales with infants with CHD after cardiothoracic surgery [ Time Frame: 1 year ]
  4. Type and Quality of oral motor skills in newborn infants as measured by NOMAS [ Time Frame: 1 year ]
  5. Type and quality of oral motor skills of infants with CHD after cardiothoracic surgery as measured by NOMAS [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy newborns and neonates with CHD
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045757


Contacts
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Contact: Jennifer L Fogel, MSCCCSLP/L 708-684-1357 jennifer.fogel@advocatehealth.com
Contact: Cheryl A Lefaiver, PhD,RN 708-684-4210 cheryl.lefaiver@advocatehealth.com

Locations
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United States, Illinois
Advocate Children's Hospital Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Jennifer L Fogel, MSCCC-SLP/L    708-684-1357    jennifer.fogel@advocateheath.com   
Contact: Cheryl Lefaiver, PhD RN CCRP    708-684-4210    cheryl.lefaiver@advocatehealth.com   
Sponsors and Collaborators
Advocate Health Care
Investigators
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Principal Investigator: Jennifer L Fogel, MSCCC-SLP/L Advocate Healthcare

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Responsible Party: Jennifer Fogel, Speech Pathologist Level III, M.S.CCC-SLP/L, Advocate Health Care
ClinicalTrials.gov Identifier: NCT03045757    
Other Study ID Numbers: 6540
K5900376 ( Other Identifier: Advocate Health Care )
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases