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 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT02415205
Eligibility Criteria:
Inclusion Criteria:
* Premature infants between 24 -32 weeks of gestational age
Exclusion Criteria:
* Infants scheduled for laser eye surgery on the day of the examination
* Infants with intraventricular hemorrhage ≥ grade 3 (Papile classification) diagnosed by head ultrasound
* Infants receiving the following medications: morphine, fentanyl, methadone, midazolam, lorazepam, muscle relaxants, phenobarbital, phenytoin, levetiracetam
* Renal injury defined with plasma creatinine \> 1.5 mg/dL
* Severe cyanotic congenital heart disease
* Unstable respiratory distress (hypoxemia PaO2 \< 50 mm Hg or SpO2 \< 90%)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
24 Weeks
Maximum Age:
32 Weeks
Study:
NCT02415205
Study Brief:
Protocol Section:
NCT02415205