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 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT01875159
Eligibility Criteria:
Inclusion Criteria:
1. Gestational age of 25 + 0 to 32 + 0 weeks PMA at birth, and 34 + 0 to 375 + 6 weeks PMA at randomization
2. Prior treatment with caffeine based on routine clinical indications, and clinical caffeine now discontinued ≥5 days before randomization
3. Previously tolerated clinical treatment with caffeine
4. Breathing room air (no current supplemental O2 treatment; may have previously required respiratory support)
5. Parental consent to enroll in pilot study
Exclusion Criteria:
1. Congenital syndrome or other medical diagnosis associated with known risk for neurodevelopmental abnormality, including intraventricular hemorrhage Grade 3 or greater, cyanotic congenital heart disease, confirmed central nervous system infection, or fetal alcohol syndrome
2. Currently receiving supplemental oxygen, ventilatory support, or nasal airflow therapy
3. Clinical decision to restart caffeine prior to completing 5 days of continuous physiologic monitoring after clinical caffeine stopped
4. Anticipated inability to meet protocol requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
33 Weeks
Maximum Age:
37 Weeks
Study:
NCT01875159
Study Brief:
Protocol Section:
NCT01875159