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:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT07262060
Eligibility Criteria:
Inclusion Criteria:
* Gestational age at birth between 23 0/7 and 29 6/7 weeks.
* Able to have near-infrared spectroscopy (NIRS) monitoring of cerebral and kidney oxygenation.
* Able to receive IV medications.
* Indwelling umbilical arterial catheter (UAC), umbilical venous catheter (UVC), peripheral arterial line (PAL), or peripherally inserted central catheter (PICC) already in place that can draw blood.
* Receiving caffeine at the time of enrollment
* Have a birth parent who is at least 18 years old and have a parent or guardian who is able to provide parental permission in English or Spanish
Exclusion Criteria:
* Known or suspected major congenital anomaly of the brain, heart, lungs or kidney (excluding UTD A1 pyelectasis).
* Known or suspected chromosomal or genetic anomaly.
* Not suitable for study participation due to other reasons at the discretion of the investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Hours
Maximum Age:
96 Hours
Study:
NCT07262060
Study Brief:
Protocol Section:
NCT07262060