NCT00728026

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2008

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2016

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

8.3 years

First QC Date

July 31, 2008

Last Update Submit

August 10, 2017

Conditions

Vomiting SyndromeIrritable Bowel SyndromePostural Orthostatic Tachycardia SyndromeAbdominal PainChronic Nausea

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

Outcome Measures

Primary Outcomes (1)

  • To gather preliminary data to characterize autonomic function in children and adolescents with functional gastrointestinal disorders.

    One year

Study Arms (5)

1

Cyclic Vomiting Syndrome

2

Irritable Bowel Syndrome

3

Postural Orthostatic Tachycardia Syndrome

4

Functional Abdominal Pain

5

Chronic Nausea

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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)

You may qualify if:

  • Outpatient services

You may not qualify if:

  • Inpatient services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Irritable Bowel SyndromePostural Orthostatic Tachycardia SyndromeAbdominal Pain

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesOrthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • B UK Li

    Medical College of Wiconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

July 31, 2008

First Posted

August 5, 2008

Study Start

June 1, 2008

Primary Completion

September 16, 2016

Study Completion

September 16, 2016

Last Updated

August 14, 2017

Record last verified: 2017-08