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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT01778634
Eligibility Criteria:
Inclusion Criteria:
* Gestational age 24 weeks 0 days-28weeks 6 days by best obstetrical estimate
* \<72 h age
* Positive pressure ventilation for at least 1 hour duration during the first 72 hours of life
* Presence of indwelling intravenous line for drug administration
Exclusion Criteria:
* Any patient judged to be non-viable or for whom withdrawal of life support is planned
* Patients with major lethal congenital anomalies
* Triplets or higher order multiples
* Patients delivered for maternal indications (low risk of Ureaplasma colonization)
* Patients with EKG QT interval corrected for heart rate (Qtc) ≥ 450 ms
* Patients with significant hepatic impairment (direct bilirubin \>1.5 mg/dL)
* Patients exposed to other systemic macrolide
* Patients with clinically suspected Ureaplasma central nervous system (CNS) infection or other confirmed bacterial/viral infection
* Patients participating in other clinical trials involving investigational products.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Hours
Maximum Age:
72 Hours
Study:
NCT01778634
Study Brief:
Protocol Section:
NCT01778634