Autonomic Profiles in Pediatric Patients With Cyclic Vomiting Syndrome, Irritable Bowel Syndrome, Postural Orthostatic Tachycardia Syndrome, Functional Abdominal Pain or Chronic Nausea
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
Sponsors
Lead Sponsor
Collaborators
Source
Medical College of Wisconsin
Oversight Info
Has Dmc
No
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.
Overall Status
Completed
Start Date
2008-06-01
Completion Date
2016-09-16
Primary Completion Date
2016-09-16
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
To gather preliminary data to characterize autonomic function in children and adolescents with functional gastrointestinal disorders. |
One year |
Number Of Groups
5
Enrollment
19
Conditions
Eligibility
Study Pop
Diagnosis of either: Cyclic Vomiting Syndrome (CVS), Irritable Bowel Syndrome (IBS),
Chronic nausea, Postural Orthostatic Tachycardia Syndrome (POTS), Functional Abdominal Pain
(FAP)
Sampling Method
Non-Probability Sample
Criteria
Inclusion Criteria:
- Outpatient services
Exclusion Criteria:
- Inpatient services
Gender
All
Minimum Age
5 Years
Maximum Age
18 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
B UK Li |
Principal Investigator |
Medical College of Wiconsin |
Verification Date
2017-08-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Medical College of Wisconsin
Investigator Full Name
B Li
Investigator Title
Professor of Pediatrics
Keywords
Chart must reveal the following procedures: 
, Heart rate variability, , Deep Breathing Test, , Valsalva maneuver, , Table test, , Thermoregulatory Sweat Testing, , Quantitative Sudomotor Axon Reflex Test (QSART), , Vital signs, , postural changes in heart rate and blood pressure, , composite autonomic score
, Heart rate variability, , Deep Breathing Test, , Valsalva maneuver, , Table test, , Thermoregulatory Sweat Testing, , Quantitative Sudomotor Axon Reflex Test (QSART), , Vital signs, , postural changes in heart rate and blood pressure, , composite autonomic score Has Expanded Access
No
Condition Browse
Secondary Id
GC 680
Arm Group
Arm Group Label
1
Description
Cyclic Vomiting Syndrome
Arm Group Label
2
Description
Irritable Bowel Syndrome
Arm Group Label
3
Description
Postural Orthostatic Tachycardia Syndrome
Arm Group Label
4
Description
Functional Abdominal Pain
Arm Group Label
5
Description
Chronic Nausea
Firstreceived Results Date
N/A
Removed Countries
Country
United States
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Case-Only
Time Perspective
Retrospective
Study First Submitted
July 31, 2008
Study First Submitted Qc
August 4, 2008
Study First Posted
August 5, 2008
Last Update Submitted
August 10, 2017
Last Update Submitted Qc
August 10, 2017
Last Update Posted
August 14, 2017
ClinicalTrials.gov processed this data on August 27, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.