Growth Hormone Deficiency
Conditions
Keywords
Growth Hormone stimulation tests
Brief summary
The diagnosis of Growth Hormone deficiency in childhood requires the performance of an artificial pharmacological stimulation tests. There are number of substances that increase the secretion of growth hormone, among them Clonidine and Arginine. One of the possible side effects of both Clonidine and Arginine is a reduction in the blood pressure due to a decreased heart output and declined contraction of peripheral blood vessels. In cases where values of blood pressure at the end of the test are not recovered after two sessions of 15 minutes of physical activity, the patient is treated with I. V of 9%NORMAL SALINE (0. 20cc /Kg) administrated over 30-60 minutes. The aim of the proposed study is to test whether administration of fluids during the combined Growth Hormone stimulation test Clonidine-Arginine will help in the recovery process from the test (blood pressure \> 90/50 mmHg after performing physical activity defined as 15-minutes hike in two consecutive sessions). The study design will be randomized, controlled, 2 arms study.
Interventions
PROCEDURE9% Sodium Chloride (NaCl) IV
9% Sodiun Chloride (NaCl) ( 20cc/kg) adminstrated intravenously
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Randomized, 2 arms, controlled study
Eligibility
Sex/Gender
ALL
Age
7 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average blood pressure | Time 180 mnutes- at time of discharging the participant | Average blood pressure ( 3 measurements in 5 minutes intervals) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average blood pressure | Time 0- prior to initiating the Growth Hormone test | Average blood pressure ( 3 measurements in 5 minutes intervals) |
| Time elapsed between completing the Growth Hormone test until participant is allowed to go home | Time 180 minutes-at time of discharging the participant (after measuring blood pressure > 50/90mm/Hg) | — |
Countries
Israel
Outcome results
None listed