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Autonomic Profiles in Pediatric Patients With Cyclic Vomiting Syndrome (CVS), Irritable Bowel Syndrome (IBS),Postural Orthostatic Tachycardia Syndrome (POTS), Functional Abdominal Pain (FAP) or Chronic Nausea

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ClinicalTrials.gov Identifier: NCT00728026
Recruitment Status : Completed
First Posted : August 5, 2008
Last Update Posted : August 14, 2017
Sponsor:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
B Li, Medical College of Wisconsin

Tracking Information
First Submitted Date July 31, 2008
First Posted Date August 5, 2008
Last Update Posted Date August 14, 2017
Study Start Date June 2008
Actual Primary Completion Date September 16, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 4, 2008)
To gather preliminary data to characterize autonomic function in children and adolescents with functional gastrointestinal disorders. [ Time Frame: One year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Autonomic Profiles in Pediatric Patients With Cyclic Vomiting Syndrome (CVS), Irritable Bowel Syndrome (IBS),Postural Orthostatic Tachycardia Syndrome (POTS), Functional Abdominal Pain (FAP) or Chronic Nausea
Official Title Autonomic Profiles in Pediatric Patients With Cyclic Vomiting Syndrome, Irritable Bowel Syndrome, Postural Orthostatic Tachycardia Syndrome, Functional Abdominal Pain or Chronic Nausea
Brief Summary Retrospectively review the charts of all children who had heart rate variability, deep breathing test, valsalva maneuver, tilt table test, thermoregulatory sweat testing, quantitative sudomotor axon reflex test (QSART) completed and were cared for at Children's Hospital of Wisconsin.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Diagnosis of either: Cyclic Vomiting Syndrome (CVS), Irritable Bowel Syndrome (IBS), Chronic nausea, Postural Orthostatic Tachycardia Syndrome (POTS), Functional Abdominal Pain (FAP)
Condition
  • Vomiting Syndrome
  • Irritable Bowel Syndrome
  • Postural Orthostatic Tachycardia Syndrome
  • Abdominal Pain
  • Chronic Nausea
Intervention Not Provided
Study Groups/Cohorts
  • 1
    Cyclic Vomiting Syndrome
  • 2
    Irritable Bowel Syndrome
  • 3
    Postural Orthostatic Tachycardia Syndrome
  • 4
    Functional Abdominal Pain
  • 5
    Chronic Nausea
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 10, 2017)
19
Original Estimated Enrollment
 (submitted: August 4, 2008)
50
Actual Study Completion Date September 16, 2016
Actual Primary Completion Date September 16, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Outpatient services

Exclusion Criteria:

  • Inpatient services
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT00728026
Other Study ID Numbers 08/112
GC 680
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party B Li, Medical College of Wisconsin
Study Sponsor Medical College of Wisconsin
Collaborators Children's Hospital and Health System Foundation, Wisconsin
Investigators
Principal Investigator: B UK Li Medical College of Wiconsin
PRS Account Medical College of Wisconsin
Verification Date August 2017