Pharmacokinetics and effects of oral clonidine in children with suspected Growth Hormone deficiency

• Conditions: Growth Hormone Deficiency; Short stature; 10021112

• Registration Number: NL-OMON31430
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- Written informed consent from parents or legal guardian, in the case of a child aged 12 years or older written informed consent from both parents/legal guardian and the child;
- Patients must be 0-17 years of age;
- Patients must have an indication for a clonidine test to investigate a possible growth hormone deficiency, and this is to be decided by or under supervision of a staff paediatrician, paediatric endocrinologist or fellow

Exclusion Criteria

None

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Pharmacokinetics of clonidine following oral administration<br /><br>- Growth hormone response following oral administration of clonidine<br /><br>- Cortisol response following oral administration of clonidine<br /><br>- Sedation depth following clonidine oral administration, measured with<br /><br>modified Ramsay Sedation Scale<br /><br>- Hemodynamic and respiratory parameters (Blood Pressure, Heart Rate,<br /><br>Transcutaneous oxygen saturation) following oral administration of clonidine</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Basal ACTH<br /><br>- Heart rate variability<br /><br>- QTc times before and after clonidine administration.</p><br>