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NCT03629093: GENIUS
Neurodevelopment of Infants Exposed to General Anesthesia: a Multi-center Investigation
trial testing General Anesthetics in General Anesthetics Toxicity in 1,000 participants. Status unknown.
30 September 2024
Quick facts
| Lead sponsor | Huashan Hospital |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 1 January 2021 |
| Primary completion | 30 September 2024 |
| Estimated completion | 30 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- General Anesthetics — full drug profile →
Conditions studied
- General Anesthetics Toxicity — all drugs for General Anesthetics Toxicity →
- Neurodevelopment — all drugs for Neurodevelopment →
- Infant — all drugs for Infant →
Sponsor
Huashan Hospital
Who can join
Adults 4 Weeks to 2, any sex, with General Anesthetics Toxicity or Neurodevelopment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Numerous preclinical evidence has confirmed that most commonly-used general anesthetics can affect neurodevelopment of young animals adversely, causing both structural defect of brain and cognitive impairment. However, it is unclear at present whether such effect would also occur to children exposed to general anesthesia in their early life. Several observational clinical studies and one interventional clinical trial indicated that short-time general anesthesia less than 80 minutes might be safe to cognitive development. Concerning long-time and/or multiple anesthesia exposure, some studies supported its association with long-term cognitive defects, while other studies did not. These studies are mainly retrospective or ambirectional researches. We have designed a prospective, multicenter cohort study to examine the neurodevelopment of infants exposed to anesthesia before age 2 in the first year after surgery, and compare the neurodevelopment status of infants exposed to anesthesia less than 3 hours and those more than 3 hours. The Gesell Developmental Inventory (GDI) and several neuropsychological testing batteries will be used. The anticipated outcome of the study will add reliable evidence from Asians to elucidate the relationship of anesthesia and long-term neurodevelopment of infants.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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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 NCT03629093 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Huashan Hospital
- Last refreshed: 25 February 2021
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/NCT03629093.
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