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 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
NCT ID:
NCT01322204
Eligibility Criteria:
Inclusion Criteria:
* Neonates ≥ 26 weeks PCA receiving mechanical ventilation and painful procedure will be eligible for participation in the study
* Subject's parent/legal guardian must give written informed consent prior to study participation
* Subject is receiving opioid analgesia therapy based on caregiver determination. The ideal patient will not be receiving morphine.
* Must be able to receive an enteral dose of codeine.
Exclusion Criteria:
* Known hypersensitivity to morphine, fentanyl, or codeine
* Patients with ALT concentrations \>2x upper limit of normal for age or clinical evidence of hepatic failure
* Patients with serum creatinine concentrations \>2x upper limit of normal for age or clinical evidence of renal failure
* Patients who are NPO
* Babies born to maternal drug abuse.
* Total serum bilirubin level of \> 10 mg/dl or 170 umol/L.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
30 Days
Study:
NCT01322204
Study Brief:
Protocol Section:
NCT01322204