NeuroCardio Baby Research Outpatient Clinic: Study on the Neurodevelopment of Infants With Congenital Heart Disease in Brazil

Congenital Heart Disease Clinical Trial

Official title:

NeuroCardio Baby Research Outpatient Clinic: Study on the Neurodevelopment of Infants With Congenital Heart Disease in Brazil

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05907109
• Other study ID #: 4864543
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: Fernanda Lucchese-Lobato, PHD
• Phone: +1(646)8304997
• Email: luccheselobato[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The objective of this randomized clinical trial is to develop low-cost hybrid remotely monitored parent-mediated multidisciplinary early intervention (EI) protocols for infants with CHD in Brazil. The protocols will be conducted via parents at home according to age modules (0- 3m, 3-6m, 6-9m, and 9-12m), and 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. The aim of this study is to prevent or reduce neurodevelopmental sequelae and developmental delays associated with CHD. Participants in the intervention group receive multidisciplinary EIs in Nutrition (including breastfeeding support), Speech and Language Therapy for tube feeding transition, feeding readiness, and language and motor development and early stimulation for global development in cognitive, language and motor skills according to age milestones. Premature infants will receive age-corrected protocols and evaluations. Caregivers will receive psychological and protocol administration support. The control group receives basic child development, nutrition, and breastfeeding information provided by the Brazilian Ministry of Health, in addition to standard of care cardiac pediatric follow-up visits. Neurodevelopment is assessed with the Brazilian Version of Bayley Developmental Scale for Infants and Toddlers (3rd edition) in both groups, at 6, 12, 24, and 36-42 months. Nutritional outcomes, such as ml of breastmilk drown by mothers, and infant weight and length are measured. The study will compare the developmental outcome scores and parental quality of life scores of the intervention and control groups during the intervention (6 and 12months) and at 1 and 2 years follow up. We believe that infants with CHD who receive monitoring and early multidisciplinary interventions in the first year of life have better neurodevelopmental outcomes than infants who do not receive early multidisciplinary care. In Brazil, access to EI services is extremely limited to urban centers and higher income families. Infants from low-income backgrounds and rural settings are likely to be left without services during early childhood. Our remote, low-cost intervention aims at increasing access to EI for Brazilian infants with CHD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Months

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Child Development
• Congenital Heart Disease
• Early Intervention
• Heart Defects, Congenital
• Heart Diseases

Intervention

Behavioral:
• Remotely monitored parent-mediated hybrid home and clinic based multidisciplinary Early Intervention protocols.
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.

Locations

Country	Name	City	State
Brazil	Instituto de Cardiologia	Porto Alegre	Rio Grande Do Sul
Brazil	Irmandade Santa Casa de Misericórdia de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Irmandade Santa Casa de Misericórdia de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Neurodevelopment Scores in infant with CHD (Bayley Scales of Infant and Toddler Development- Third Edition)	Amercian Heart Association recommends surveillance, screening, evaluation in the nerudovelopment in pediatric congenital heart disease (CHD) population. The Bayley Scales of Infant and Toddler Development- Third Edition is a recognized scale the assessment the Infant Neudevelopment in cognitive, language and motor domains.	From six months of age

External Links

•   Neurodevelopmental outcomes in children with congenital heart disease: evaluation and management: a scientific statement from the American Heart Association