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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT01434251
Eligibility Criteria:
Inclusion Criteria:
* Idiopathic arterial hypotension as defined by a mean BP in mmHg less than the GA in weeks at birth.
* Written parental consent
Exclusion Criteria:
* Prior inclusion indirect clinical or direct laboratory evidence of poor organ/tissue perfusion (plasma lactate \>6 mmol/L on two consecutive measurements and/or urine production \<0.6 mL/kg/h for a 6-hour period
* Clinically and/or microbiologically proven sepsis
* Major congenital abnormalities
* Postnatal age at the time of the development of systemic hypotension \>72 hours
* No arterial line for continuously monitoring of blood pressure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
24 Weeks
Maximum Age:
30 Weeks
Study:
NCT01434251
Study Brief:
Protocol Section:
NCT01434251