Dysphagia of NewbornNCT03045757
Evaluating Dysphagia in Neonates With CHD
An observational study of Dysphagia of Newborn, run by Wake Forest University Health Sciences at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 1 day to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Dysphagia of Newborn
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2017to 13 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy newborns and neonates with CHD
Who may be able to join
- 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).
Who cannot join
- 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)
Show all 9Show fewer
- Down Syndrome
- Trisomy 13, Trisomy 18
- Congenital anomalies of facial structure or musculature specifically cleft lip, hard or soft palate
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Children's Hospital
Oak Lawn, Illinois, 60453
About this study
Official title: 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.
- Conditions
- Dysphagia of Newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Newborn | Healthy Newborn | |
| CHD Neonates | Neonates born with CHD before and after surgical repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral motor skills of infants with CHD utilizing the NOMAS
Measured: 1 year
Type and quality of oral motor skills of infants with CHD before cardiothoracic surgery as measured by NOMAS
Measured: 1 year
Type and quality of feeding readiness using the Infant Driven Feeding Scales with infants with CHD after cardiothoracic surgery
Measured: 1 year
Type and Quality of oral motor skills in newborn infants as measured by NOMAS
Measured: 1 year
Type and quality of oral motor skills of infants with CHD after cardiothoracic surgery as measured by NOMAS
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start3 Jan 2017
- Primary completion13 Oct 2023
- Study completion13 Oct 2023
Why it stopped: Dr. Fogel left the organization, and no other clinician was available to continue the study. Data was never collected for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphagia of NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer L Fogel, MSCCC-SLP/L, Principal investigator, Advocate Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045757
- Sponsor's protocol ID
- 6540
- Other IDs
- K5900376
- Status last verified
- Aug 2024
- First submitted
- 26 Jan 2017
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Oral Motor Skills of Neonates Requiring Congenital Heart Surgery and the Impact on Oral Feeding Readiness
- ClinicalTrials.gov ID
- NCT03045757
- Acronym / sponsor ID
- 6540
- Conditions
- Dysphagia of Newborn
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Dr. Fogel left the organization, and no other clinician was available to continue the study. Data was never collected for the study.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 13 Oct 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Newborn | – | –Healthy Newborn |
| CHD Neonates | – | –Neonates born with CHD before and after surgical repair |
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy newborns and neonates with CHD
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (9 listed)
- Full-term newborn arm
- Newborn admitted into the NICU
- Genetic syndromes
- Congenital abnormalities or signs of developmental delay
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oral motor skills of infants with CHD utilizing the NOMAS
Time frame: 1 year
Type and quality of oral motor skills of infants with CHD before cardiothoracic surgery as measured by NOMAS
Time frame: 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
Type and Quality of oral motor skills in newborn infants as measured by NOMAS
Time frame: 1 year
Type and quality of oral motor skills of infants with CHD after cardiothoracic surgery as measured by NOMAS
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Dr. Fogel left the organization, and no other clinician was available to continue the study. Data was never collected for the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer L Fogel, MSCCC-SLP/L principal investigator
Advocate Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia of Newborn, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Dr. Fogel left the organization, and no other clinician was available to continue the study. Data was never collected for the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral motor skills of infants with CHD utilizing the NOMAS (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024; AzTrials last refreshed its copy on 29 Oct 2026.