Last reviewed · How we verify

NCT05907109

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

Status unknown NA Last updated 18 June 2023
What this trial tests

NA trial testing Remotely monitored parent-mediated hybrid home and clinic based multidisciplinary Early Intervention protocols. in Congenital Heart Disease in 300 participants. Status unknown.

Timeline
16 March 2021
Primary endpoint
31 December 2024
31 December 2025

Quick facts

Lead sponsorInstituto de Cardiologia do Rio Grande do Sul
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment300
Start date16 March 2021
Primary completion31 December 2024
Estimated completion31 December 2025
Sites2 locations across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

Instituto de Cardiologia do Rio Grande do Sul — full company profile →

Who can join

Under 2 Months, any sex, with Congenital Heart Disease or Child Development. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The molecular mechanisms of cardiac development and related diseases.
    Li Y, Du J, Deng S, Liu B, et al · · 2024 · cited 53× · PMID 39715759 · DOI 10.1038/s41392-024-02069-8
  2. 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.
    Michelon RC, Lucchese-Lobato F. · · 2024 · cited 1× · PMID 38922306 · DOI 10.1080/17518423.2024.2365796

Verify or expand the search:

Other recruiting trials for Congenital Heart Disease

Currently open trials in the same condition.

Other Instituto de Cardiologia do Rio Grande do Sul trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05907109.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing