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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT00879957
Eligibility Criteria:
Inclusion Criteria:
* Neonates admitted to the Neonatal Intensive Care Unit (NICU) at University Hospital in San Antonio, Texas who require a percutaneous central venous catheter, as determined by the attending neonatologist.
Exclusion Criteria:
* Evidence of bleeding (prolonged aPTT)
* Recent sepsis (w/in 48 hours of initiation of antimicrobial therapy)
* Propensity for stroke or thrombophilia
* Requiring heparinization (i.e. dialysis)
* Discretion of the neonatologist (severe illness to the point of uncertain viability, poor intravenous access requiring surgical placement of a long term intravenous catheter e.g. Broviac)
* Requirement of a 1 French catheter
* Uncertain viability (this is based on the discretion of the infant's neonatologist who is not a member of the research team)
* Nonviable neonates (this is based on the discretion of the infant's neonatologist who is not a member of the research team)
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
1 Year
Study:
NCT00879957
Study Brief:
Protocol Section:
NCT00879957