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

NCT04152330 | Completed

• 1 other identifier: 5553/18
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

Congenital heart disease; Children developmental; Parents training

Outcome Measures

Primary Outcomes (1)

• Difference between groups

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

  6 moths

Study Arms (1)

Comparison between intervention and control group

OTHER

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.

Other: Early stimulation protocol on neuropsychomotor development of children with congenital heart disease

Interventions

Early stimulation protocol on neuropsychomotor development of children with congenital heart disease OTHER

A parenting guidance booklet will be prepared. It will contain a specific program of stimulation activities for each stage of development in simple language and with illustrations. Subdivided into 4 areas: Cognition, Language, Large Motor and Fine Motor. The duration will be 6 weeks. Parents will participate in 1 individual face-to-face meeting, where they will receive information and clarification on the application of the booklet and will have a mobile communication channel to answer questions throughout the process. Parents will be instructed on the capabilities and limitations of their babies according to the child's congenital heart disease, as well as what is expected within the typical development for this age group and the importance of early stimulation activities in each child in 4 areas of development.

Comparison between intervention and control group

Eligibility Criteria

• Age: 3 Months - 9 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• For babies
• Diagnosis of congenital heart disease up to 3 months old.
• Stable clinical condition (with medical clearance to receive the intervention), For parents
• Parents are literate
• Acceptance of the Responsible to participate in the research.
• Have a mobile device capable of sending and receiving messages and videos.

You may not qualify if:

• For babies
• Suspected or diagnosed genetic syndrome;
• Musculoskeletal or neurological malformation associated
• inability to establish a primary caregiver as in the case of baby under state supervision.
• for parents
• Illiteracy
• Presence of deafness, blindness or physical disability, when another family member cannot be responsible for the application of the protocol.

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Study Sites (1)

Instituto de cardiologia de porto alegre

Porto Alegre, Rio Grande do Sul, 90040-001, 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 Officials

• Fernanda Lucchese, Doutora

  Instituto de cardiologia de porto alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: November 5, 2019
• Study Start: November 30, 2019
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: June 23, 2023

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)