Evaluating Dysphagia in Neonates With CHD | NCT03045757

Studies
Evaluating Dysphagia in Neonates With CHD

NCT03045757

Sponsor

Wake Forest University Health Sciences

Status

Terminated

Last Update Posted

Oct 4, 2024Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Dysphagia of Newborn

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
K5900376	Other Identifier	Advocate Health Care

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Dr. Fogel left the organization, and no other clinician was available to continue the study. Data was never collected for the study.

Expanded Access Info

Start Date

Jan 3, 2017Actual

Primary Completion Date

Oct 13, 2023Actual

Completion Date

Oct 13, 2023Actual

First Submitted Date

Jan 26, 2017

First Submission Date that Met QC Criteria

Feb 4, 2017

First Posted Date

Feb 7, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2024

Last Update Posted Date

Oct 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Label	Type	Description	Intervention Names
Healthy Newborn		Healthy Newborn
CHD Neonates		Neonates born with CHD before and after surgical repair

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Full-term newborns with normal physical exam that are delivered > 37 weeks gestation (healthy newborn arm).

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

3 Months

Standard Ages

Child

Study Population

Healthy newborns and neonates with CHD

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Jennifer L Fogel, MSCCC-SLP/L	Advocate Healthcare	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Advocate Children's Hospital		Oak Lawn	Illinois	60453	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided