Deglutition Disorders in ChildrenNCT07481565
Speech Therapy Online Approach for Children With Congenital Heart Desease in Pre and Post Surgical Period
A study testing Oral motor intervention in people with Deglutition Disorders in Children and Congenital Heart Disease, run by Instituto de Cardiologia do Rio Grande do Sul at 2 sites in Brazil.
Trial summary
The goal of this clinical trial is to test the results of a protocoled speech therapy online intervention in children with congenital heart disease aged between 0 and 12 months old, who feeds tube only. Read more about this study
- Who is it for?
- Ages 0 to 12 months
- Conditions the study is for
- Deglutition Disorders in Children, Congenital Heart Disease
- What is being tested?
- Oral motor intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Mar 2022to 30 May 2024
- Phase
- Interventional
- 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 0 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with congenital heart desease
- Féd by tube only
- Aged 0 to 12 months
Who cannot join
- Children with vocal folds palsy
- Children with cerebral comitment
- Children who feds oraly
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Irmandade Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-190
Instituto de Cardiologia
Porto Alegre, Rio Grande do Sul, 90620-001.
About this study
The goal of this clinical trial is to test the results of a protocoled speech therapy online intervention in children with congenital heart disease aged between 0 and 12 months old, who feeds tube only.
The main questions it aims to answer are:
Read more
- Does this online protocoled intervention helps to improve milk volume consumed by the babies though oral intake?
- Does the ability to swallow improves by this online speech therapy approach?
Participants will be evaluated on a video call by a blinded speech therapist and will receive 10 days online intervention by the speech therapist researcher who has 10 years expertise on this population. At the end of the 10 days intervention, they will be evaluated once more by the blinded speech therapist.
Researchers will compare intervention and no intervention groups to see if there is any improvement on the oral intake volume of milk taken orally by the baby and if there is improvement on the ability of swallowing.
Read the detailed description
The main questions it aims to answer are:
- Does this online protocoled intervention helps to improve milk volume consumed by the babies though oral intake?
- Does the ability to swallow improves by this online speech therapy approach?
Participants will be evaluated and will receive online intervention by the speech therapist researcher. At the end of the 10 days intervention, they will be evaluated once more.
- Being tested
- Oral motor intervention
- Keywords
- swallowing impairment, swallowing in clildren, congenital heart defects, dysphagia in infants, congenital heart disease
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral motor interventionBehavioural
Participants will get orientations on oral stimulation. Adition informations on aversive behavior and dysphagia is also provided.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention group | Experimental | Intervention group After the patient's consent, a standardized complementary questionnaire will be applied, with sociodemographic and clinical information. A questionnaire assessing the life quality of the carer is also applied.
After that, the first evaluation is caried out by the blinded speech therapist. The babies are classified by level 1, level 2 or level 3, depending on the ability to manage milk orally. So they are allocated on the randomization table. Receives: Behavioral: Oral motor intervention |
| No intervention: Control group | No intervention | Evaluation is done after enrollment and again, after 10 days. So than, the infants receive the 10 days intervention, for ethical issues. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the feasibility of a telehealth parent-mediated SLT intervention program designed to promote feeding abilities in infants with congenital heart disease (CHD) who rely on alternative feeding routes.
Oral intake of milk volume ingestion.
Measured: Before and after 10 days of speech therapy synchronous online intervention
Secondary outcomes (1)
Oralmotor hability
Functional Oral Intake Scale (FOIS) was used to classify the oralmotor ability for feeding by using the protocol designed for this study
Measured: Before and after 10 days of speech therapy synchronous online intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Mar 2022
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition Disorders in ChildrenStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial, with single blind evaluation of outcomes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Irmandade Santa Casa de Misericórdia de Porto Alegre
- Responsible party
- Principal investigator, Fernanda Lucchese, Instituto de Cardiologia do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481565
- Sponsor's protocol ID
- 596721
- Status last verified
- Mar 2026
- First submitted
- 13 Jul 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech Therapy Online Approach for Children With Congenital Heart Desease in Pre and Post Surgical Period
- ClinicalTrials.gov ID
- NCT07481565
- Acronym / sponsor ID
- 596721
- Keywords
- swallowing impairment, swallowing in clildren, congenital heart defects, dysphagia in infants, congenital heart disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Collaborators
- Irmandade Santa Casa de Misericórdia de Porto Alegre
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 19 Mar 2026 (actual)
- 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 goal of this clinical trial is to test the results of a protocoled speech therapy online intervention in children with congenital heart disease aged between 0 and 12 months old, who feeds tube only.
The main questions it aims to answer are:
- Does this online protocoled intervention helps to improve milk volume consumed by the babies though oral intake?
- Does the ability to swallow improves by this online speech therapy approach?
Participants will be evaluated on a video call by a blinded speech therapist and will receive 10 days online intervention by the speech therapist researcher who has 10 years expertise on this population. At the end of the 10 days intervention, they will be evaluated once more by the blinded speech therapist.
Researchers will compare intervention and no intervention groups to see if there is any improvement on the oral intake volume of milk taken orally by the baby and if there is improvement on the ability of swallowing.
Detailed description
The main questions it aims to answer are:
- Does this online protocoled intervention helps to improve milk volume consumed by the babies though oral intake?
- Does the ability to swallow improves by this online speech therapy approach?
Participants will be evaluated and will receive online intervention by the speech therapist researcher. At the end of the 10 days intervention, they will be evaluated once more.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial, with single blind evaluation of outcomes.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention group | Experimental | Behavioral: Oral motor interventionIntervention group After the patient's consent, a standardized complementary questionnaire will be applied, with sociodemographic and clinical information. A questionnaire assessing the life quality of the carer is also applied. After that, the first evaluation is caried out by the blinded speech therapist. The babies are classified by level 1, level 2 or level 3, depending on the ability to manage milk orally. So they are allocated on the randomization table. |
| No intervention: Control group | No intervention | –Evaluation is done after enrollment and again, after 10 days. So than, the infants receive the 10 days intervention, for ethical issues. |
Who may qualify
- Ages
- 0 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with congenital heart desease
- Féd by tube only
- Aged 0 to 12 months
Key exclusion criteria (3 listed)
- Children with vocal folds palsy
- Children with cerebral comitment
- Children who feds oraly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral motor interventionParticipants will get orientations on oral stimulation. Adition informations on aversive behavior and dysphagia is also provided. | Behavioural | Experimental: Intervention group |
Primary outcome
Assessment of the feasibility of a telehealth parent-mediated SLT intervention program designed to promote feeding abilities in infants with congenital heart disease (CHD) who rely on alternative feeding routes.
Time frame: Before and after 10 days of speech therapy synchronous online intervention
Oral intake of milk volume ingestion.
1 secondary outcome
Oralmotor hability
Time frame: Before and after 10 days of speech therapy synchronous online intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral motor intervention in people with Deglutition Disorders in Children and Congenital Heart Disease, run by Instituto de Cardiologia do Rio Grande do Sul at 2 sites in Brazil.
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 3 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: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of the feasibility of a telehealth parent-mediated SLT intervention program designed to promote feeding abilities in infants with congenital heart disease (CHD) who rely on alternative feeding routes. (time frame: Before and after 10 days of speech therapy synchronous online intervention). 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 19 Mar 2026.