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Electro-acupuncture (EA) in Children Undergoing Procedures for Congenital Heart Defects.

NCT03297658 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2024-08-21

No results posted yet for this study

Summary

This is a single site, randomized, blinded, sham controlled, parallel group study to identify whether electro-acupuncture (EA) is a beneficial anesthesia adjunct in children undergoing procedures on their congenital heart defects (CHD).

Conditions

  • Congenital Heart Defect

Interventions

DEVICE

electro-acupuncture (EA)

stimulation of acupuncture points related to congenital heart surgery for comfort heart and renal health

DEVICE

sham

Micro electrodes will be placed but there will be no stimulation

Sponsors & Collaborators

  • West Virginia University

    lead OTHER

Principal Investigators

  • David A Rosen, MD · West Virginia University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-15
Primary Completion
2024-08-14
Completion
2024-08-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03297658 on ClinicalTrials.gov