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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT03938857
Eligibility Criteria:
Inclusion Criteria:
1. Ages 0 to \<18 years at the time of enrollment.
2. If \< 6 months postnatal age, gestational age ≥ 35 weeks.
3. Admitted to an intensive care unit.
4. Planned or anticipated mechanically ventilation for ≥2 days.
5. Require sedation to maintain mechanical ventilation per clinical judgment.
6. No contraindication to receipt of fentanyl or dexmedetomidine per clinician judgment.
7. Availability and willingness of the parent/legal guardian to provide written informed consent.
Exclusion Criteria:
1. Previous participation in this study.
2. Severe traumatic brain injury as the underlying etiology for critical illness requiring mechanical ventilation or baseline pediatric cerebral performance category (PCPC) \>3.
3. Planned receipt of sedatives other than fentanyl or dexmedetomidine.
4. Anticipated receipt of neuromuscular blockade for \>48 consecutive hours during the study period.
5. Receipt of fentanyl or dexmedetomidine via continuous infusion for \>12 hours in the 24 hours prior to enrollment.
6. Extracorporeal life support (including renal replacement therapy, extracorporeal membrane oxygenation, ventricular assist device, etc.) at the time of enrollment.
7. Chronic use of or recent overdose of serotonergic agents (selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase (MAO) inhibitors, cyclic antidepressants)
8. Known pregnancy
9. Known liver dysfunction, defined as: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2x the upper limit of normal for age
10. Known or impending renal failure defined as: anuria \> or equal to 12 hours prior to enrollment or requiring renal replacement therapy
11. High risk children, define as: a. known heart block b. known bradyarrythmia including clinically significant bradycardia (defined as requiring chronotropic agents or cardiac pacing to treat)
12. Receipt of mechanical ventilation during an admission for cardiac surgery
Note: receipt of drugs other than fentanyl or dexmedetomidine for intubation, and receipt of neuromuscular blockage for intubation, will not be considered exclusionary criteria.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT03938857
Study Brief:
Protocol Section:
NCT03938857