Clinical trial NCT04152330: Proposal for Parental Guidance and Early Stimulation in Children With Congenital Heart Disease: Randomized Trial
Official title: Proposal for Parental Guidance and Early Stimulation in Children With Congenital Heart Disease: Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Keywords: Congenital heart disease
Children developmental
Parents training
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 44
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Difference between groups
timeFrame: 6 moths
Secondary outcomes:
Other outcomes:
Locations:
city: Porto alegre
country: Brazil
facility: Instituto de cardiologia de porto alegre
state: RS
Study officials:
affiliation: Instituto de cardiologia de porto alegre
name: Fernanda Lucchese, Doutora
role: PRINCIPAL_INVESTIGATOR
References: