NeuroCardio Baby Research Outpatient Clinic: Study on the Neurodevelopment of Infants With Congenital Heart Disease in Brazil
1 other identifier
interventional
300
1 country
2
Brief Summary
The objective of this randomized clinical trial is to test the effectiveness of a low-cost hybrid remotely monitored parent-mediated and clinic-based multidisciplinary early intervention (EI) for low-income infants with CHD in Brazil. The intervention protocols will be administered according to age modules, families will be monitored weekly. High risk infants also receive supplemental clinic-based interventions according to developmental needs. Controls will receive standard of care and access to early child development and nutrition practices information from the Brazilian Ministry of Health. All infants will be evaluated at within a 42-month follow-up research outpatient clinic, called NeuroCardio Baby at Santo Antonio Pediatric Hospital, of the Santa Casa de Misericordia Hospital Complex, and affiliated with The Cardiology Institute-University Foundation of Cardiology (IC-FUC), Porto Alegre, Brazil.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 16, 2021
CompletedFirst Submitted
Initial submission to the registry
June 8, 2023
CompletedFirst Posted
Study publicly available on registry
June 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJune 18, 2023
June 1, 2023
3.8 years
June 8, 2023
June 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compose the Neuropsychomotor profile of babies with CHD in multidisciplinary outpatient follow-up and compare to the group without follow-up.
Compose the Neuropsychomotor profile of babies with CHD in multidisciplinary outpatient follow-up and compare to the group without follow-up using Bayley Scales of Infant and Toddler Development- Third Edition).
From six months of age
Secondary Outcomes (1)
Neurodevelopment Scores in infant with CHD (Bayley Scales of Infant and Toddler Development- Third Edition)
From six months of age
Study Arms (2)
Intervention
EXPERIMENTALRemotely monitored parent-mediated hybrid home and clinic based multidisciplinary Early Intervention protocols.
Control Group - Standart of Care
NO INTERVENTION* The control group receives basic guidelines on child development, nutrition, and breastfeeding provided by the Brazilian Ministry of Health, in addition to standard of care cardiac pediatric follow-up visits. * Infants will receive outcome developmental evaluations within a 42-month follow-up clinic.
Interventions
* Parents receive manualized protocols, instructional videos, and toy and material kits to administer EIs at home. * New modules are provided according to infant age or stage of intervention during the length of brief interventions or 12-months. * The families will be monitored by clinical researchers weekly. -High risk infants will receive supplemental EI services at the clinic according to developmental needs. * Infants will receive outcome evaluations within a 42-month follow-up clinic.
Eligibility Criteria
You may qualify if:
- Pregnant women with a fetal diagnosis of CHD
- Child up to two months diagnosed with CHD
- Signature of the electronic free and informed consent form by those parents or legal guardians.
You may not qualify if:
- Psychiatric or neurocognitive condition that prevents obtaining reliable clinical data (defined by the clinical judgment of the investigators)
- Inability to read by parents or legal guardians.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Irmandade Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-190, Brazil
Instituto de Cardiologia
Porto Alegre, Rio Grande do Sul, 90620-001., Brazil
Related Publications (2)
Marino BS, Lipkin PH, Newburger JW, Peacock G, Gerdes M, Gaynor JW, Mussatto KA, Uzark K, Goldberg CS, Johnson WH Jr, Li J, Smith SE, Bellinger DC, Mahle WT; American Heart Association Congenital Heart Defects Committee, Council on Cardiovascular Disease in the Young, Council on Cardiovascular Nursing, and Stroke Council. Neurodevelopmental outcomes in children with congenital heart disease: evaluation and management: a scientific statement from the American Heart Association. Circulation. 2012 Aug 28;126(9):1143-72. doi: 10.1161/CIR.0b013e318265ee8a. Epub 2012 Jul 30.
PMID: 22851541RESULTMichelon RC, Lucchese-Lobato F. A remote parent-led early intervention protocol to promote motor development in infants with congenital heart disease: a feasibility pilot study of a randomized clinical trial. Dev Neurorehabil. 2024 Apr-May;27(3-4):134-144. doi: 10.1080/17518423.2024.2365796. Epub 2024 Jun 26.
PMID: 38922306DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fernanda Lucchese-Lobato, PHD
Instituto De Cardiologia/Fundação Universitária De Cardiologia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Assessors blinded to the allocation of participants
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PHD
Study Record Dates
First Submitted
June 8, 2023
First Posted
June 18, 2023
Study Start
March 16, 2021
Primary Completion
December 31, 2024
Study Completion
December 31, 2025
Last Updated
June 18, 2023
Record last verified: 2023-06