Congenital Heart DiseaseNCT04152330
Proposal for Parental Guidance and Early Stimulation in Children With Congenital Heart Disease: Randomized Trial
A study testing Early stimulation protocol on neuropsychomotor development of children with congenital heart disease in people with Congenital Heart Disease, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 9 months
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Early stimulation protocol on neuropsychomotor development of children with congenital heart disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Nov 2019to 30 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de cardiologia de porto alegre
Porto Alegre, Rio Grande do Sul, 90040-001
About this study
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
- Being tested
- Early stimulation protocol on neuropsychomotor development of children with congenital heart disease
- Keywords
- Congenital heart disease, Children developmental, Parents training
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early stimulation protocol on neuropsychomotor development of children with congenital heart diseaseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Early stimulation protocol on neuropsychomotor development of children with congenital heart disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between groups
Early intervention prevents developmental delays in children with congenital heart disease.
Measured: 6 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start30 Nov 2019
- Primary completion30 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernanda Lucchese, Doutora, Principal investigator, Instituto de cardiologia de porto alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152330
- Sponsor's protocol ID
- 5553/18
- Status last verified
- Jul 2020
- First submitted
- 25 Jun 2019
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal for Parental Guidance and Early Stimulation in Children With Congenital Heart Disease: Randomized Trial
- ClinicalTrials.gov ID
- NCT04152330
- Acronym / sponsor ID
- 5553/18
- Conditions
- Congenital Heart Disease
- Keywords
- Congenital heart disease, Children developmental, Parents training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison between intervention and control group | Other | Other: Early stimulation protocol on neuropsychomotor development of children with congenital heart diseaseThe 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. |
Who may qualify
- Ages
- 3 to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early stimulation protocol on neuropsychomotor development of children with congenital heart diseaseA 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. | Other | Comparison between intervention and control group |
Primary outcome
Difference between groups
Time frame: 6 moths
Early intervention prevents developmental delays in children with congenital heart disease.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernanda Lucchese, Doutora principal investigator
Instituto de cardiologia de porto alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early stimulation protocol on neuropsychomotor development of children with congenital heart disease in people with Congenital Heart Disease, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between groups (time frame: 6 moths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.