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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease; Deglutition Disorders in Children
• Intervention / Treatment: Behavioral: Oral motor intervention

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-190
      • Irmandade Santa Casa de Misericordia de Porto Alegre
    • Porto Alegre, Rio Grande do Sul, Brazil, 90620-001.
      • Instituto de Cardiologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Intervention group; 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; Participants will get orientations on oral stimulation. Adition informations on aversive behavior and dysphagia is also provided.
No Intervention: No intervention: Control group; Evaluation is done after enrollment and again, after 10 days. So than, the infants receive the 10 days intervention, for ethical issues.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oralmotor hability	Functional Oral Intake Scale (FOIS) was used to classify the oralmotor ability for feeding by using the protocol designed for this study	Before and after 10 days of speech therapy synchronous online intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feeding Ability Stage and Level due to the proposed protocol	Feeding development stage and ability level	Before and After 10-day intervention
Dysphagia Evaluation PAD-PED	Dysphagia Evaluation (PAD-PED): Instrument to levels of Dysphasia in infants, Validated for the Brazilian Population	Before and after 10 days of speech therapy synchronous online intervention
Feeding Ability Scale	Feeding Readiness Scale	Before and After 10-day telehealth SLT synchronous intervention.

Collaborators and Investigators

• Sponsor: Instituto de Cardiologia do Rio Grande do Sul
• Collaborators: Irmandade Santa Casa de Misericórdia de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: July 13, 2024
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: congenital heart disease; congenital heart defects; swallowing impairment; swallowing in clildren; dysphagia in infants
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: 596721

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No