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 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT01360450
Eligibility Criteria:
Inclusion Criteria:
* \>35 week Gestational Age (GA) at birth
* \<3 months (90 days) old chronological age at the time of enrollment
* Exposed to a minimum five days of continuous narcotic infusion
Exclusion Criteria:
* Neurologic abnormality which would make Neonatal Abstinence Score (NAS) scoring inaccurate
* Major chromosomal abnormality (with the exception of Trisomy 21)
* Infant already enrolled in another randomized, controlled clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Days
Maximum Age:
90 Days
Study:
NCT01360450
Study Brief:
Protocol Section:
NCT01360450