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:
NCT01734551
Eligibility Criteria:
Inclusion Criteria:
* Admitted to Neonatal Intensive Care Unit (NICU)- Gestational age (GA) \>or= 35 wks
* Known prenatal opiate exposure (maternal history, positive opiate screen, positive neonatal urine or meconium screen)
* Symptomatic with Finnegan Neonatal Abstinence Scores meeting NICU protocol for treatment
Exclusion Criteria:
* Seizures
* Major congenital malformations
* Unlikely to survive
* Parents not able to understand English
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
7 Days
Study:
NCT01734551
Study Brief:
Protocol Section:
NCT01734551