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 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT00496951
Eligibility Criteria:
Inclusion Criteria:
* Term infant (\>= 37 weeks by 1st or second trimester sonogram),
* In utero opiate exposure (either heroin or methadone) requiring a minimum of three day infant hospitalization after birth
* Delivery to a client active in drug abuse treatment
Exclusion Criteria:
* Significant medical complications in the infant
* Circumcision within 24 hours of the proposed EKG/vagal tone measurement (circumcision has been found to affect vagal tone)
* Infant hospitalization in the Neonatal Intensive Care Unit (NICU)
* Psychiatric impairment of the mother such that informed consent is not possible
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
1 Day
Study:
NCT00496951
Study Brief:
Protocol Section:
NCT00496951