Initially intubated and mechanically ventilated preterm subjects ... 28 weeks through 1000 g, in an intensive care setting anticipated to require at least 6 hours of continuous intravenous sedation.
Conditions
Sponsors
Hospira Inc
Eligibility
Sex/Gender
All
Inclusion 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. 2. Age: subjects had to be in the following age range at screening: Preterm subjects z 28 weeks through 1000 g. 4. Subject's parent(s) or legal guardian(s) had voluntarily signed and dated the informed consent document approved by the IRB/ IEC. Are the trial subjects under 18? yes Number of subjects for this age range: 6 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Neonate subjects with neurological conditions that prohibited an evaluation of sedation such as:o Diminished consciousness from increased intracranial pressure. O 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. O Subjects with immobility from neuromuscular disease or continuous infusion of neuromuscular blocking (NMB) agents. 2. Subjects with second degree or third degree heart block unless subject has a pacemaker or pacing wires were in situ. Note: If subject's status-post Cardiopulmonary Bypass (CPB) was being managed without pacing wires in situ, the subject could not have been suspected to be in second degree or third degree heart block at the time of DEX administration. 3. HR 115 UIL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study was 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.;Secondary Objective: Not applicaple;Primary end point(s): The primary efficacy endpoint for the study was the frequency of subjects requiring any use of rescue medication, midazolam (MDZ), for sedation during DEX infusion;Timepoint(s) of evaluation of this end point: Each subject received a 10- or 20- minute loading dose infusion of DEX followed by a continuous fixed maintenance dose infusion of DEX for at least 6 hours but not more than 24 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Incidence of rescue medication use (fentanyl or morphine) for analgesia during DEX infusion ° Amount of rescue medication (MDZ) for sedation during DEX infusion • Amount of rescue medication for analgesia during DEX infusion ° Change from baseline in vital signs (heart rate, blood pressure, mean arterial pressure), respiratorySafety: • the incidence of AEs ° Changes from baseline in vital signs ° Changes from screening in clinical laboratory tests ° Changes in input/output fluid balance 0 Changes from baseline in ECG ° Use of rescue regimens to support vital signs ° Use of adjunct medications rate and oxygen saturation measures during DEX infusion 0 Time spent with a total N-PASS score >3 during DEX infusion ° Time to extubation was explored in DEX-exposed subjects;Timepoint(s) of evaluation of this end point: Each subject received a 10- or 20- minute loading dose infusion of DEX followed by a continuous fixed maintenance dose infusion of DEX for at least 6 hours but not more than 24 hours. | — |
Countries
United States
Contacts
Public ContactGlobai Clinical R&D and Medical Aff
Hospira Inc
Outcome results
None listed