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

Not Applicable

Completed

• Conditions: Congenital Heart Disease
• Interventions: Other: Early stimulation protocol on neuropsychomotor development of children with congenital heart disease

• Registration Number: NCT04152330
• Lead Sponsor: Instituto de Cardiologia do Rio Grande do Sul

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-25
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-05
• Study Start: 2019-11-30
• Status Verified: 2020-07
• Primary Completion: 2020-08-30
• Study Completion: 2020-08-30
• Last Update Submitted: 2023-06-21
• Last Update Posted: 2023-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Comparison between intervention and control group	Early stimulation protocol on neuropsychomotor development of children with congenital heart disease	The subjects will be randomized to two groups, intervention group (IG) and control group (CG). Each day GI Parents-Baby receives guidance for 6 weeks of stimulation activities and will be instructed to keep an online execution diary, directly with the researcher of videos and messages via cell phone. "Parents" is understood as a generalist nomenclature and will be considered a parent, mother or principal. GC subjects receive standard guidance from the pediatric and pediatric cardiology clinic.

Primary Outcome Measures

Name	Time	Method
Difference between groups	6 moths	Early intervention prevents developmental delays in children with congenital heart disease.

Trial Locations

Locations (1)

Instituto de cardiologia de porto alegre; 🇧🇷 Porto alegre, RS, Brazil