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NCT05907109
NeuroCardio Baby Research Outpatient Clinic: Study on the Neurodevelopment of Infants With Congenital Heart Disease in Brazil
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.
31 December 2024
Quick facts
| Lead sponsor | Instituto de Cardiologia do Rio Grande do Sul |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 16 March 2021 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2025 |
| Sites | 2 locations across Brazil |
Drugs / interventions tested
- Remotely monitored parent-mediated hybrid home and clinic based multidisciplinary Early Intervention protocols.
Conditions studied
- Congenital Heart Disease — all drugs for Congenital Heart Disease →
- Child Development — all drugs for Child Development →
- Early Intervention — all drugs for Early Intervention →
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):
-
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 -
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:
- PubMed search for NCT05907109
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Instituto de Cardiologia do Rio Grande do Sul trials
Trials by the same sponsor.
- NCT06917729 — Breathing Exercises of CardioBreath Application on Autonomic and Vascular Function in Hypertension · NA · not yet recruiting
- NCT06497946 — Effects of SlimTrack® Platform on Diet Adherence, Anthropometry and Arterial Stiffness in Postmenopausal Women · NA · recruiting
- NCT06282302 — Effect of Isometric and Aerobic Physical Exercise on Blood Pressure Levels in Hypertensive Elderly People · NA · unknown
- NCT06139653 — CardioBreathApp vs IMT in Heart Failure · NA · completed
- NCT03672760 — Inspiratory Muscle Training X CardioBreath App Effects On Vagal Modulation And Pulse Wave Velocity · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05907109 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Instituto de Cardiologia do Rio Grande do Sul
- Last refreshed: 18 June 2023
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