Phase 3
Completed N=6
Open-Label, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥28 Weeks to <36 Weeks Gestational Age
Anesthesia
Source: ClinicalTrials.gov NCT01508455 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: Percent of Subjects Requiring Rescue Midazolam for Sedation — 0 percentage of participants
Summary
The primary objective of this study is to characterize the safety, and efficacy of Dexmedetomidine (DEX) administered as an intravenous (IV) loading dose followed by a continuous IV infusion in preterm subjects, ages ≥ 28 weeks through < 36 weeks gestational age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects Requiring Rescue Midazolam for Sedation |
— | — |
| SECONDARY Incidence of Rescue Medication (Fentanyl or Morphine) Use for Analgesia During DEX Infusion |
1 | — |
| SECONDARY Amount of Rescue Medication (Midazolam) for Sedation During Dexmedetomidine Infusion |
— | — |
| SECONDARY Amount of Rescue Medication for Analgesia During DEX Infusion |
1 | — |
| SECONDARY Time Spent With a Total N-PASS Score >3 During DEX Infusion |
0.44 | — |
| SECONDARY Time to Successful Extubation |
37.3 | — |
Eligibility Criteria
Inclusion Criteria
- Initially intubated and mechanically ventilated pediatric subjects in an intensive care setting anticipated to require at least 6 hours of continuous IV sedation.
- Age: subjects must fit the following age range at screening:
Preterm subjects ≥28 weeks through 1000 g.
- Subject's parent(s) or legal guardian(s) has/have voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
Exclusion Criteria
- Neonate subjects with neurological conditions that prohibit an evaluation of sedation such as:
- Diminished consciousness from increased intracranial pressure.
- The presence of catastrophic brain injury or other severe mental disorders that would make responses to sedatives unpredictable and/or measurement of the N-PASS unreliable.
- Subjects with immobility from neuromuscular disease or continuous infusion of neuromuscular blocking (NMB) agents.
- Subjects with second degree or third degree heart block unless subject has a pacemaker or pacing wires are in situ.
Note: If subject's status-post Cardio Pulmonary Bypass (CPB) was managed without pacing wires in situ, the subject must not be suspected to be in second degree or third degree heart block at the time of DEX administration.
- HR 115 U/L.
Data sourced from ClinicalTrials.gov (NCT01508455). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.