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Speech Therapy Online Approach for Children With Congenital Heart Desease in Pre and Post Surgical Period

Speech Therapy Online Approach for Children With Congenital Heart Desease in Pre and Post Surgical Period

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07481565
Enrollment
20
Registered
2026-03-19
Start date
2022-03-01
Completion date
2024-05-30
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease, Deglutition Disorders in Children

Keywords

swallowing impairment, swallowing in clildren, congenital heart defects, dysphagia in infants, congenital heart disease

Brief 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. 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.

Interventions

BEHAVIORALOral motor intervention

Participants will get orientations on oral stimulation. Adition informations on aversive behavior and dysphagia is also provided.

Sponsors

Instituto de Cardiologia do Rio Grande do Sul
Lead SponsorOTHER
Irmandade Santa Casa de Misericórdia de Porto Alegre
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

The participants will be assessed by a blinded speech therapist before and after intervention.

Intervention model description

Randomized clinical trial, with single blind evaluation of outcomes.

Eligibility

Sex/Gender
ALL
Age
0 Months to 12 Months
Healthy volunteers
No

Inclusion criteria

* Children with congenital heart desease * Féd by tube only * Aged 0 to 12 months

Exclusion criteria

* Children with vocal folds palsy * Children with cerebral comitment * Children who feds oraly

Design outcomes

Primary

MeasureTime frameDescription
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.Before and after 10 days of speech therapy synchronous online interventionOral intake of milk volume ingestion.

Secondary

MeasureTime frameDescription
Oralmotor habilityBefore and after 10 days of speech therapy synchronous online interventionFunctional Oral Intake Scale (FOIS) was used to classify the oralmotor ability for feeding by using the protocol designed for this study

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026