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NCT04733378: CINC
Impact of Surgical Timing on the Neurodevelopmental Prognosis of Newborns With Complex Congenital Heart Disease
NA trial testing Peri-operative neurological monitoring in Complex Congenital Heart Disease in 50 participants. Status unknown.
24 December 2025
Quick facts
| Lead sponsor | Assistance Publique Hopitaux De Marseille |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 50 |
| Start date | 24 December 2021 |
| Primary completion | 24 December 2025 |
| Estimated completion | 24 December 2025 |
| Sites | 1 location across France |
Drugs / interventions tested
- Peri-operative neurological monitoring
Conditions studied
- Complex Congenital Heart Disease — all drugs for Complex Congenital Heart Disease →
Sponsor
Assistance Publique Hopitaux De Marseille — full company profile →
Who can join
Adults 0 Months to 2 Months, any sex, with Complex Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
We propose a prospective observational study whose main objective will be to determine whether there is an association between age at surgery (days of life) and neurodevelopmental outcome in patients with CCHD. Secondly, we will study the relationship between age at surgery and (i) the incidence of WMI observed on pre- and post-operative cerebral MRI (ii) post-operative morbidity as defined by the occurrence of post-operative complications (haemodynamic, infectious, neurological, surgical) and (iii) the length of hospital stay.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Impact of cardiac surgical timing on the neurodevelopmental outcomes of newborns with Complex congenital heart disease (CHD).
Lenoir M, Beretti T, Testud B, Resseguier N, et al · · 2023 · cited 6× · PMID 37033180 · DOI 10.3389/fped.2023.1003585 -
Novel Frontiers in Pediatric Cardiology: Beyond the Heart.
López-Guillén JL, Pérez-López P, Solaz-García Á, Williams EE. · · 2025 · PMID 40286363 · DOI 10.1016/j.jacadv.2025.101697
Verify or expand the search:
- PubMed search for NCT04733378
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Complex Congenital Heart Disease
Currently open trials in the same condition.
- NCT07363538 — Multicenter Randomized Controlled Trial (RCT) and Efficacy Evaluation System Study on Surgical Innovation Strategies for · NA · recruiting
- NCT06884046 — Support for the Management of Parental Stress in Surgical Resuscitation of Congenital Heart Diseases · NA · recruiting
- NCT07524998 — A Chinese Multicenter Study on Surgical Techniques and Outcomes Across the Lifespan in Congenital Heart Disease · recruiting
Other Assistance Publique Hopitaux De Marseille trials
Trials by the same sponsor.
- NCT07521644 — Dysbiosis of Methanogenic Archaea and Nanoarchaea in the Oral Microbiome · NA · not yet recruiting
- NCT07357025 — Resting-State fMRI Study of Functional Connectivity After Gamma Knife Radiosurgery in Trigeminal Neuralgia · NA · not yet recruiting
- NCT07356661 — Evaluation of the Efficacy of Neurofeedback Technique Based on EEG Desynchronization in Epileptic Patients · NA · not yet recruiting
- NCT07399327 — Biomarkers of Response to SEEG Thermocoagulation · NA · not yet recruiting
- NCT06999499 — Development of an Aid to Melanoma Detection Using Artificial Intelligence Algorithms Based on Images From the VECTRA 3D · NA · not yet 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 NCT04733378 (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 Assistance Publique Hopitaux De Marseille
- Last refreshed: 8 January 2024
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/NCT04733378.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing