Early intervention for infants with congenital heart disease in Brazil
NeuroCardio Baby Research Outpatient Clinic: Study on the Neurodevelopment of Infants With Congenital Heart Disease in Brazil
This study is testing a new low-cost support program for infants with congenital heart disease in Brazil to see if it helps their development better than standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | N/A to 2 Months |
| Sex | All |
| Sponsor | Instituto de Cardiologia do Rio Grande do Sul Academic / other |
| Locations | 2 sites (Porto Alegre, Rio Grande Do Sul and 1 other locations) |
| Trial ID | NCT05907109 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a low-cost hybrid intervention combining remote monitoring and in-clinic support for infants with congenital heart disease (CHD) in Brazil. Families will receive age-specific developmental support at home, with weekly monitoring by clinical researchers, while high-risk infants will also access additional clinic-based services. The study will assess neurodevelopmental outcomes over a 42-month follow-up period, comparing the intervention group to a control group receiving standard care and information from the Brazilian Ministry of Health.
Who should consider this trial
Good fit: Ideal candidates include pregnant women with a fetal diagnosis of CHD and infants up to two months old diagnosed with CHD.
Not a fit: Patients with psychiatric or neurocognitive conditions that hinder reliable data collection may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve neurodevelopmental outcomes for infants with congenital heart disease.
How similar studies have performed: Other studies have shown promise in using hybrid interventions for developmental support in similar populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Porto Alegre, Rio Grande Do Sul and 1 other locations
- Irmandade Santa Casa de Misericórdia de Porto Alegre — Porto Alegre, Rio Grande Do Sul, Brazil (Recruiting)
- Instituto de Cardiologia — Porto Alegre, Rio Grande Do Sul, Brazil (Recruiting)
Study contacts
- Principal investigator: Fernanda Lucchese-Lobato, PHD — Instituto De Cardiologia/Fundação Universitária De Cardiologia
- Study coordinator: Fernanda Lucchese-Lobato, PHD
- Email: luccheselobato@gmail.com
- Phone: +1(646)8304997
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.