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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT06552351
Eligibility Criteria:
Infants requiring lumbar puncture for diagnostic or therapeutic purposes
* Age 0 to 3 months
* Parental/guardian consent obtained
Exclusion Criteria:
* Infants with known allergy or hypersensitivity to lidocaine or components of the needle-free jet injection device
* Infants with significant skin infection or dermatitis at the site of injection
* Infants with coagulopathy or any bleeding disorder
* Infants with any other condition that, in the opinion of the investigator, would make participation in the study unsafe or not in the best interest of the infant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
3 Months
Study:
NCT06552351
Study Brief:
Protocol Section:
NCT06552351