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 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT06694103
Eligibility Criteria:
Inclusion Criteria:
* Gestational age \<34 weeks,
* Birth weight ≤ 2500 grams,
* No painful interventions at least 1 hour before the ROP examination,
* Fed at least 1 hour before the ROP examination,
* Premature infants whose parents consented to participate in the study.
Exclusion Criteria:
* Having a condition that prevents pain assessment (intracranial hemorrhage, neuromotor developmental delay etc.)
* Any congenital anomaly (eye, neurological, etc.),
* Have a diagnosed hearing problem,
* A different painful procedure was performed at least one hour before the ROP examination,
* Administration of an analgesic/sedative medication before the examination,
* Premature infants whose parents did not consent to participate in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
28 Weeks
Maximum Age:
33 Weeks
Study:
NCT06694103
Study Brief:
Protocol Section:
NCT06694103