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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 2 months
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Brazil
Instituto de Cardiologia
RECRUITING
Porto Alegre
Irmandade Santa Casa de Misericórdia de Porto Alegre
RECRUITING
Porto Alegre
Contact Information
Primary
Fernanda Lucchese-Lobato, PHD
luccheselobato@gmail.com
+1(646)8304997
Time Frame
Start Date: 2021-03-16
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 300
Treatments
Experimental: Intervention
Remotely monitored parent-mediated hybrid home and clinic based multidisciplinary Early Intervention protocols.
No_intervention: Control Group - Standart of Care
* 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.
Related Therapeutic Areas
Sponsors
Collaborators: Irmandade Santa Casa de Misericórdia de Porto Alegre, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Leads: Instituto de Cardiologia do Rio Grande do Sul

This content was sourced from clinicaltrials.gov