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

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ClinicalTrials.gov Identifier: NCT04152330
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Instituto de Cardiologia do Rio Grande do Sul

Brief Summary:

Problem: With the increased survival rate of children with congenital heart disease, other health issues, other than just the disease clinic, have emerged, such as the risks to 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 intervention vectors on the neurodevelopment of children with severe congenital heart disease.

Methodology: Randomized clinical trial conducted with children with congenital heart disease considered at high risk for developmental delay according to the American Heart Association (2012) guidelines from birth to the first year of life. The study will consist of two groups G1 (cases) and G2 (controls). G1 parents will receive stimulation activity guidance at 2 different times, at 30 days and at 3 months. Parents will also be instructed to keep an online execution diary, direct with the researcher through video, and mobile messaging. G2 parents will receive the standard guidelines currently used in the follow-up services of children with congenital heart disease. Children in both groups will be assessed at 3 and 6 months by the Bayley Scales of Baby and Toddler Development (3rd Edition).

Expected Results: Better neuropsychomotor performance of children after application of early stimulation protocol.

Perspectives: Create a body of information that can serve as a basis for formulating intervention policies and surveillance of the development of this population.


Condition or disease Intervention/treatment Phase
Congenital Heart Disease Early Childhood Caries Other: Early stimulation protocol on neuropsychomotor development of children with congenital heart disease Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Proposal for Parental Guidance and Early Stimulation in Children With Congenital Heart Disease: Randomized Trial
Actual Study Start Date : May 30, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Comparison between intervention and control group

Subjects will be randomized to two groups, intervention group (IG) and Control group (CG). Each GI Parents-Baby dyad will receive 4 interventions, which will take place at predetermined dates (at 30 days, 3 months, 6 months, and 9 months) with groups of up to 5 pairs of participants. "Parents" is understood to be a generalist nomenclature and will be considered as parent, parent or primary caregiver.

CG subjects will receive standard guidelines from the pediatric and pediatric cardiology outpatient clinic.

Other: Early stimulation protocol on neuropsychomotor development of children with congenital heart disease
A parent 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, Broad Motor, and Fine Motor. The duration will be 6 months, with intervention at 30 days and 3 months. Parents will attend 2 individual meetings, where they will receive information and clarifications on the application of the booklet. Parents will be advised about the capabilities and limitations of their babies according to the congenital heart disease the child has, as well as what is expected within the typical development for that age group, and the importance of early stimulation activities in each child. one of 4 development areas. They will be informed about the need for that stimulus for the baby's development, as well as possible doubts about the stimulus.




Primary Outcome Measures :
  1. Difference between groups [ Time Frame: 6 moths ]
    Early intervention prevents developmental delays in children with congenital heart disease.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04152330


Contacts
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Contact: Mariane L Silva, Mestre 051996169863 marianelopes.to@hotmail.com

Locations
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Brazil
Instituto de cardiologia de porto alegre Recruiting
Porto alegre, RS, Brazil, 90040-001
Contact: Mariane L Silva, Mestre    51996169863    marianelopes.to@hotmail.com   
Sponsors and Collaborators
Instituto de Cardiologia do Rio Grande do Sul
Investigators
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Principal Investigator: Fernanda Lucchese, Doutora Instituto de cardiologia de porto alegre

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Responsible Party: Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT04152330     History of Changes
Other Study ID Numbers: 5553/18
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto de Cardiologia do Rio Grande do Sul:
Congenital heart disease
Children developmental
Parents training
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities