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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT03321734
Eligibility Criteria:
Inclusion Criteria:
1. Male and female infants born preterm at ≤30 weeks + 6 days post menstrual age
2. Current treatment with routine caffeine
3. PMA 32 weeks + 0 days - 36 weeks + 6 days
4. Anticipated last dose of routine caffeine will be by 36 weeks + 5 days
5. At least 12 hours of breathing room air with no ventilatory support other than on room air nasal air flow therapy regardless of flow rate, or on room air and receiving nasal CPAP, and relapse not anticipated.
6. Able to tolerate enteral medications
7. It is feasible to administer the first dose of study drug no later than 36 weeks + 6 days PMA
Exclusion Criteria:
1. Intraventricular hemorrhage Grade III-IV or cystic periventricular leukomalacia
2. Current or prior treatment for seizures
3. Current or prior treatment for cardiac arrhythmias
4. Known renal or hepatic dysfunction that in the opinion of the investigator would have a clinically relevant impact on caffeine metabolism
5. Major malformation, inborn error of metabolism, chromosomal abnormality
6. Presence of a condition for which survival to discharge unlikely
7. Social, mental health, logistical or other issues that, in the opinion of the investigator, would impact the ability of the family to complete the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
32 Weeks
Maximum Age:
36 Weeks
Study:
NCT03321734
Study Brief:
Protocol Section:
NCT03321734