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| Name | Class |
|---|---|
| Irmandade Santa Casa de Misericórdia de Porto Alegre | OTHER |
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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:
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.
The main questions it aims to answer are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral motor intervention | Behavioral | Participants will get orientations on oral stimulation. Adition informations on aversive behavior and dysphagia is also provided. |
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| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irmandade Santa Casa de Misericórdia de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-190 | Brazil | ||
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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Randomized clinical trial, with single blind evaluation of outcomes.
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The participants will be assessed by a blinded speech therapist before and after intervention.
| 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. |
| Instituto de Cardiologia |
| Porto Alegre |
| Rio Grande do Sul |
| 90620-001. |
| Brazil |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |