Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04152330
Enrollment
44
Registered
2019-11-05
Start date
2019-11-30
Completion date
2020-08-30
Last updated
2023-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Keywords

Congenital heart disease, Children developmental, Parents training

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.

Interventions

OTHEREarly stimulation protocol on neuropsychomotor development of children with congenital heart disease

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.

Sponsors

Instituto de Cardiologia do Rio Grande do Sul
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Months to 9 Months
Healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Difference between groups6 mothsEarly intervention prevents developmental delays in children with congenital heart disease.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026