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Completed

NCT Number: NCT07481565

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

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.

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Key information

Conditions

Deglutition Disorders in Children Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

0 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Cardiologia, Porto Alegre, Rio Grande do Sul, Brazil

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral motor intervention

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Oralmotor hability

    Time frame: Before and after 10 days of speech therapy synchronous online intervention

    Functional Oral Intake Scale (FOIS) was used to classify the oralmotor ability for feeding by using the protocol designed for this study

Other outcomes

  1. Feeding Ability Stage and Level due to the proposed protocol

    Time frame: Before and After 10-day intervention

    Feeding development stage and ability level

  2. Dysphagia Evaluation PAD-PED

    Time frame: Before and after 10 days of speech therapy synchronous online intervention

    Dysphagia Evaluation (PAD-PED): Instrument to levels of Dysphasia in infants, Validated for the Brazilian Population

  3. Feeding Ability Scale

    Time frame: Before and After 10-day telehealth SLT synchronous intervention.

    Feeding Readiness Scale

Sponsors and collaborators

Lead sponsor

Instituto de Cardiologia do Rio Grande do Sul

Other

Collaborators

  • Irmandade Santa Casa de Misericórdia de Porto Alegre

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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