Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT01940250
Eligibility Criteria:
Inclusion Criteria:
* Age 6 months to 15 years
* Clinical suspicion of HFMD requiring PICU/HDU admission
* Considered severe enough to warrant invasive blood pressure monitoring by PICU/HDU staff
* Development of hypertension defined as follows:
* For children aged 1 year and over, at least 3 consecutive systolic blood pressure recordings above the 95th centile for age, gender and length (USA guidelines for defining Stage 1 hypertension in children, (Appendix 2)) measured invasively over a period of 20 minutes provided the child is not distressed or crying \[30, 31\].
* For children aged 6 months to 1 year, systolic BP \> 100 mm Hg measured invasively on at least 3 occasions over a period for 20 minutes provided the child is not distressed or crying
* Plus one or more of the following criteria:
* Tachypnoea for age
* Irregular or labored breathing, but with SpO2 above 92% in air and normal ABG (pH, pCO2, pO2, HCO3 all within the normal range for the local laboratory)
* Resting heart rate \> 150 bpm
* Mottled skin
* Profuse sweating
* Refractory fever
* Hyperglycemia
* Informed consent
Exclusion Criteria:
* Past history of hypertension, chronic renal, cardiac or pulmonary disease, or any neurological disorder
* Hypertensive emergency
* Already commenced milrinone or any other inotropic agents
* Respiratory distress with SpO2\<92% in air or PaCO2\>45 mm Hg
* AV block or any arrhythmia
* Acute renal failure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
15 Years
Study:
NCT01940250
Study Brief:
Protocol Section:
NCT01940250