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:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT05937594
Eligibility Criteria:
Inclusion Criteria:
* Newborns ≥35weeks gestation with chronic in-utero opioid exposure (\>1month of gestation exposure). Maternal exposure will be determined by evaluating the medical records for maternal medication use, maternal urine toxicology and neonatal meconium toxicology results per standard clinical care
* Neonates born at Penn State Hershey Medical Center or transferred at \<48 hours after birth
* Mothers with chronic in-utero opioid use during pregnancy ( ≥1month of gestation)
Exclusion Criteria:
* \<35 week gestation
* Infant required mechanical ventilation or non-invasive mechanical support
* Infant exposure to magnesium sulfate
* Opioid-exposed neonates who are actively receiving dextrose infusion for persistent neonatal hypoglycemia at the time of enrollment (\<48hours after birth).
* Infant with major congenital anomalies
* Parent or guardian unable to provide consent
* Mothers and neonates without history of opioid exposure/dependence
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
5 Days
Study:
NCT05937594
Study Brief:
Protocol Section:
NCT05937594