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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT04928651
Eligibility Criteria:
Inclusion Criteria:
* Preterm infants (\< gw 37+0) who are in need for analgesic or sedative medication according to clinical judgment (scoring with pain assessment scales; ALPS-Neo and Comfort-Neo)
* Existing arterial or venous cannulas/catheters for repeated non-traumatic blood sampling
* Informed and written parental consent
Exclusion Criteria:
* Hemodynamic instability (same as in clinical routine).
* Cardiac malformations in need for postnatal surgery.
* Any serious medical condition or ethical issues that could, in the Investigators opinion, interfere with the study procedures.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
37 Weeks
Study:
NCT04928651
Study Brief:
Protocol Section:
NCT04928651