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Clinical Trials/NCT04152330
NCT04152330
Completed
Not Applicable

Proposal for Parental Guidance and Early Stimulation in Children With Congenital Heart Disease: Randomized Trial

Instituto de Cardiologia do Rio Grande do Sul1 site in 1 country44 target enrollmentNovember 30, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Enrollment
44
Locations
1
Primary Endpoint
Difference between groups
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Problem: With the increased survival rate of children with congenital heart disease, other health problems, in addition to the clinic, have emerged, such as the risks of developmental delay to which these children are exposed. There is a need for low-cost intervention studies that seek to minimize these risks.

Objective: To evaluate the effect of an early stimulation program using parents as vectors of intervention, on the neurodevelopment of children with CHD Methodology: Randomized clinical trial, conducted with 44 dyads of parents-babies with CH considered as medium and high risk for developmental delays according to the guidelines of the American Heart Association (2012). The study will consist of two groups G1 (Intervention) and G2 (controls). G1 parents will receive guidance for 6 weeks of stimulation activities and will be instructed to keep an online execution diary, direct with the researcher through videos, and messages via cell phone. G2 parents will receive the standard guidelines currently used in pediatric cardiology clinics. Children from both groups will be assessed at the beginning and end of the 6 weeks by the Bayley Baby and Toddler Development Scales (3rd Edition). A questionnaire on the applicability of the protocol will be administered to the parents of the intervention group Expected results: Better neuropsychomotor performance in children after applying the early stimulation protocol.

Perspectives: Create a body of information that can serve as a basis for the formulation of policies for intervention and surveillance of the development of this population.

Registry
clinicaltrials.gov
Start Date
November 30, 2019
End Date
August 30, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Difference between groups

Time Frame: 6 moths

Early intervention prevents developmental delays in children with congenital heart disease.

Study Sites (1)

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