Initially intubated and mechanically ventilated preterm neonates = 28 weeks through 1000 g
Conditions
Sponsors
Hospira Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Initially intubated and mechanically ventilated pediatric subjects in an intensive care setting anticipated to require a minimum of 6 hours of continuous IV sedation. 2. The ability to complete all PK sampling blood draws. NB: The presence of an indwelling venous or arterial catheter for blood sampling; with an umbilical venous or arterial catheter is preferred but not required. 3. Age: subjects must fit into 1 of the following age ranges at screening: • Preterm neonates = 28 weeks through 1000 g. 5. 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). Are the trial subjects under 18? yes Number of subjects for this age range: 42 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 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. 2. Subjects with second degree or third degree heart block unless subject has a pacemaker or pacing wires are in situ. 3. HR 115 U/L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to characterize the safety, efficacy and PK of DEX administered as an IV loading dose followed by a continuous IV infusion in neonates, ages = 28 weeks through = 44 weeks gestational age;Secondary Objective: Not applicable;Primary end point(s): The primary efficacy endpoint for the study was the incidence of subjects requiring any rescue medication (midazolam [MDZ]) for sedation during DEX infusion. The primary PK parameters were as follows: ? CL (plasma clearance) and ? CLw (weight adjusted CL;Timepoint(s) of evaluation of this end point: the minimum duration of DEX infusion is 6 hours and the maximum duration of infusion will not exceed 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints included: ? Incidence of rescue medication use for analgesia during DEX infusion ? (a) The total amount and (b) the weight adjusted total amount (per kg) of rescue medication of MDZ, morphine, or fentanyl given for sedation and analgesia during DEX infusion ? Change from baseline in vital signs (heart rate [HR], systolic blood pressure [SBP], diastolic blood pressure [DBP], mean arterial pressure [MAP], respiration rate [RR], and oxygenation [SpO2]) during DEX infusion ? Time spent with a total Neonatal Pain, Agitation and Sedation Scale (N-PASS) score > 3 and = 3 during DEX infusion ? Time to extubation was explored in DEX-exposed subjects;Timepoint(s) of evaluation of this end point: the minimum duration of DEX infusion is 6 hours and the maximum duration of infusion will not exceed 24 hours | — |
Countries
United States
Contacts
Public ContactGlobal Clinical R&D and Medical Aff
Hospira Inc
Outcome results
None listed