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

Primary Purpose

Congenital Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Early stimulation protocol on neuropsychomotor development of children with congenital heart disease
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congenital Heart Disease focused on measuring Congenital heart disease, Children developmental, Parents training

Eligibility Criteria

3 Months - 9 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • High risk classification for delay according to American Heart Association (2012)
  • Stable Clinical Chart
  • Diagnosis of Congenital heart disease up to 30 days of life.
  • Accept from Responsible to participate in the survey.
  • Have a mobile device capable of sending and receiving messages and videos.

Exclusion Criteria:

  • Suspected or diagnosed genetic syndrome;
  • Babies whose parents are not literate, as this will make it impossible to perform the protocol.

Sites / Locations

  • Instituto de cardiologia de porto alegre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Comparison between intervention and control group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 25, 2019
Last Updated
June 21, 2023
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT04152330
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 30, 2019 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
August 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
Congenital heart disease, Children developmental, Parents training

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comparison between intervention and control group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Early stimulation protocol on neuropsychomotor development of children with congenital heart disease
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference between groups
Description
Early intervention prevents developmental delays in children with congenital heart disease.
Time Frame
6 moths

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
9 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernanda Lucchese, Doutora
Organizational Affiliation
Instituto de cardiologia de porto alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de cardiologia de porto alegre
City
Porto alegre
State/Province
RS
ZIP/Postal Code
90040-001
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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