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NCT05120531 · ClinicalTrials.gov registry record

Down Syndrome Autonomic Nervous System Induction Bradycardia

A clinical trial, sponsored by Children's Hospital Medical Center, Cincinnati.

Completed
Registry status
195
Enrollment target

NCT05120531 is a clinical trial that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 195 participants.

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The verdict

NCT05120531 has completed, sponsored by Children's Hospital Medical Center, Cincinnati.

COMPLETED
Registry status
195 participants
Enrollment target

Study Summary

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.

Interventions

  • OTHER Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia

Trial Details

FieldValue
Enrollment Target 195 participants
Start Date 2022-01-04
Est. Completion 2023-12-12

What the Registry Record Tells You About NCT05120531

The ClinicalTrials.gov registry entry for NCT05120531 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 195 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia is the first listed.

NCT05120531 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05120531 about?

NCT05120531 is a clinical study titled "Down Syndrome Autonomic Nervous System Induction Bradycardia". 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 popul...

What is the current status of trial NCT05120531?

This trial is currently completed. The enrollment target is 195 participants. The study started on 2022-01-04. Estimated completion is 2023-12-12.

What interventions are being tested in trial NCT05120531?

The interventions under investigation include: Monitoring patients undergoing surgery to look for association between ANS activity and bradycardia (OTHER).

Who is sponsoring clinical trial NCT05120531?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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