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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31430

Enrollment

Registered

2007-03-22

Start date

2007-05-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

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

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
- Pharmacokinetics of clonidine following oral administration - Growth hormone response following oral administration of clonidine - Cortisol response following oral administration of clonidine - Sedation depth following clonidine oral administration, measured with modified Ramsay Sedation Scale - Hemodynamic and respiratory parameters (Blood Pressure, Heart Rate, Transcutaneous oxygen saturation) following oral administration of clonidine	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
- Basal ACTH - Heart rate variability - QTc times before and after clonidine administration.	—

Countries

Netherlands

Outcome results