Last reviewed · How we verify
NCT05120531: DANSIB
Down Syndrome Autonomic Nervous System Induction Bradycardia
trial testing Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia in Down Syndrome in 195 participants. Completed in 12 December 2023.
12 December 2023
Quick facts
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 195 |
| Start date | 4 January 2022 |
| Primary completion | 12 December 2023 |
| Estimated completion | 12 December 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia
Conditions studied
- Down Syndrome — all drugs for Down Syndrome →
- Bradycardia — all drugs for Bradycardia →
Sponsor
Children's Hospital Medical Center, Cincinnati
Who can join
Adults 1 Month to 8, any sex, with Down Syndrome or Bradycardia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Children with Down syndrome (DS) often experience dangerously low heart rates on induction of anesthesia for routine procedures and this occurs at 10 times the rate of non-DS patients. Given that the cardiac output of children is heart rate dependent, bradycardia is especially perilous in this population. Historically, individuals with DS were not expected to survive beyond childhood; consequently, correction of congenital anomalies, e.g. cardiac defects, was not frequently offered. Fortunately, today individuals with DS live into adulthood and surgical correction of anomalies is universally offered. Thus, increasing numbers of children with DS are exposed to anesthesia and at risk for this hemodynamic catastrophe. It is medically unacceptable and an autonomic nervous system mechanism will be sought.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Prospective Observational Study of Sympathetic Failure as a Mechanism Associated with Bradycardia During Induction of General Anesthesia in Children with Down Syndrome.
Sinton JW, Marcum S, Duan Q, Geisler K, et al · · 2024 · cited 1× · PMID 40376277 · DOI 10.4274/jpr.galenos.2024.87528
Verify or expand the search:
- PubMed search for NCT05120531
- 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 Children's Hospital Medical Center, Cincinnati trials
Trials by the same sponsor.
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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 NCT05120531 (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 Children's Hospital Medical Center, Cincinnati
- Last refreshed: 15 December 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/NCT05120531.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing