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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: 12 December 2020
Main ID:  NCT04465565
Date of registration: 03/07/2020
Prospective Registration: Yes
Primary sponsor: Rabin Medical Center
Public title: Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test
Scientific title: Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test- Randomized, 2 Arms, Controlled Study
Date of first enrolment: December 2020
Target sample size: 120
Recruitment status: Not yet recruiting
URL:  https://clinicaltrials.gov/show/NCT04465565
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Israel
Contacts
Name:     Alona Hamou, MSc
Address: 
Telephone: 972-3-9253282
Email: alonah@clalit.org.il
Affiliation: 
Name:     Moshe Phillip, Prof
Address: 
Telephone: 972-544-795995
Email: moshe.phillip@phillipmd.com
Affiliation: 
Name:     Moshe Phillip, Prof
Address: 
Telephone:
Email:
Affiliation:  Schneider Children's Medical Center, Israel
Key inclusion & exclusion criteria

Inclusion Criteria:

- Children referred to combined Arginine- Conidine Growth Hormone stimulation test

- Girls: 7-14 years old and Boys: 7-16 years old

- Weight>20 kg

- Normal thyroid function

Exclusion Criteria:

- BMI over percentile 85

- Genetic syndromes or chromosomal disorders

- Steroid treatment

- Renal failure

- Heart failure



Age minimum: 7 Years
Age maximum: 16 Years
Gender: All
Health Condition(s) or Problem(s) studied
Growth Hormone Deficiency
Intervention(s)
Procedure: 9% Sodium Chloride (NaCl) IV
Primary Outcome(s)
Average blood pressure [Time Frame: Time 180 mnutes- at time of discharging the participant]
Secondary Outcome(s)
Average blood pressure [Time Frame: Time 0- prior to initiating the Growth Hormone test]
Average blood pressure [Time Frame: Time 150 minutes after completing the Arginine adminstration]
Average blood pressure [Time Frame: Time 90 minutes after completing the Arginine adminstration]
Time elapsed between completing the Growth Hormone test until participant is allowed to go home [Time Frame: Time 180 minutes-at time of discharging the participant (after measuring blood pressure > 50/90mm/Hg)]
Secondary ID(s)
RMC068119ctil
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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