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

NCT07481565 | Completed DMC

• 1 other identifier: 596721
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Deglutition Disorders in Children; Congenital Heart Disease

Keywords

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

Outcome Measures

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.

  Oral intake of milk volume ingestion.

  Before and after 10 days of speech therapy synchronous online intervention

Secondary Outcomes (1)

• Oralmotor hability

  Before and after 10 days of speech therapy synchronous online intervention

Other Outcomes (3)

• Feeding Ability Stage and Level due to the proposed protocol

  Before and After 10-day intervention

• Dysphagia Evaluation PAD-PED

  Before and after 10 days of speech therapy synchronous online intervention

• Feeding Ability Scale

  Before and After 10-day telehealth SLT synchronous intervention.

Study Arms (2)

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.

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.

Interventions

Oral motor intervention BEHAVIORAL

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

Experimental: Intervention group

Eligibility Criteria

• Age: 0 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead
• Irmandade Santa Casa de Misericórdia de Porto Alegre: collaborator

Study Sites (2)

Irmandade Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-190, Brazil

Location

Instituto de Cardiologia

Porto Alegre, Rio Grande do Sul, 90620-001., Brazil

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The participants will be assessed by a blinded speech therapist before and after intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized clinical trial, with single blind evaluation of outcomes.

Study Record Dates

• First Submitted: July 13, 2024
• First Posted: March 19, 2026
• Study Start: March 1, 2022
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

BR (2)