The 'how to survive my dex days' study.

Completed

• Conditions: - dexamethasone induced cerebral side-effects on mood, behaviour, and cognition- secondary: other side-effects of dexamethasone; e.g. side-effects like diabetes mellitus, insulin resistance, visceral fat gain, hypertension and hypercholesterolemiaDutch: neuropsychologische bijwerkingen, stemming, gedrag, cognitie

• Registration Number: NL-OMON23013
• Lead Sponsor: Erasmus Medical Center

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1. Written informed consent;

2. Age 3-16;

Exclusion Criteria

1. Patient or parent refusal;

2. Anticipated compliance problems;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome parameter is the parent-reported strength and difficulty questionnaire in Dutch (SDQ-Dut) 20 after 5 days of dexamethasone treatment with or without cortisol. In the general population mean SDQ score is 7,0 (1 SD= 6,0)20 . We expect the mean SDQ-Dut score of the children after 5 days of dexamethasone treatment to be around 15 in the control group.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome parameters are mood and behaviour questionnaires and (neuro-)cognitive tests and metabolic parameters (Data on body composition will be obtained. Height and weight will be measured. Waist-hip circumpherence and blood pressure will be measured. Fasting blood samples will be taken to measure lipid profiles (triglycerides, cholesterol, HDL, LDL), glucose and insulin levels).