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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 29 June 2015
Main ID:  NCT02134652
Date of registration: 29/04/2014
Prospective Registration: Yes
Primary sponsor: University of Massachusetts, Worcester
Public title: Ability of Bedside Ultrasound to Predict Progression of Severity of Disease in Dengue Fever
Scientific title: Ability of Bedside Ultrasound to Predict Progression of Severity of Disease in Dengue Fever
Date of first enrolment: January 2015
Target sample size: 0
Recruitment status: Withdrawn
URL:  http://clinicaltrials.gov/show/NCT02134652
Study type:  Observational
Study design:  Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Cambodia
Contacts
Name:     Romolo Gaspari, M.D., Ph.D.
Address: 
Telephone:
Email:
Affiliation:  University of Massachusetts, Worcester
Name:     Samuel D Licciardo, M.D.
Address: 
Telephone:
Email:
Affiliation:  University of Massachusetts, Worcester
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age >3 months and <16 years

2. Clinical suspicion of dengue hemorrhagic fever. (Revised WHO Classification System)

3. Not a prisoner or ward of the state

4. Parents able and willing to give consent. Children older then 7 able and willing to
give assent

Exclusion Criteria:

1. Allergic to Ultrasound gel

2. Prisoners or wards of the state

3. Unstable patients

4. Known pleural effusion, ascites, or gallbladder wall thickening.



Age minimum: 3 Months
Age maximum: 16 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Dengue
Disease Progression
Intervention(s)
Other: diagnostic bedside ultrasound
Primary Outcome(s)
Progression of Disease [Time Frame: Patients who are discharged from home will be contacted a maximum of 10 days after discharge to acquire follow up data. Those patients who are admitted to the hospital will monitored for the entirety of their hospital stay, an average of about 2 weeks.]
Secondary Outcome(s)
Clinical Care [Time Frame: Patients will receive an ultrasound in the emergency department or outpatient department. Within 2 hours of study enrollment, the treating physician will be made aware of the test results and will be queried for changes in decision making.]
Secondary ID(s)
EUS-3325
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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