SedationPhase 2/3NCT01159262
Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age
A Phase 2/3 study testing Midazolam, Fentanyl/Morphine and Dexmedetomidine in people with Sedation, run by Hospira, now a wholly owned subsidiary of Pfizer at 18 sites in 2 countries.
Trial summary
The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading dose followed by a continuous infusion for a minimum of 6 hours and up to 24 hours in the… Read more about this study
- Who is it for?
- Ages 28 to 44 weeks
- Conditions the study is for
- Sedation
- What is being tested?
- Midazolam, Fentanyl/Morphine and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Jul 2010to Aug 2011
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 44 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Initially intubated and mechanically ventilated pediatric subjects in an intensive care setting anticipated to require a minimum of 6 hours of continuous IV sedation.
- The ability to complete all PK sampling blood draws.
- Age: subjects must fit into 1 of the following age ranges at screening:
- Preterm neonates ≥28 weeks through <36 weeks, gestational age; this would constitute treatment Group I.
- Term neonates born at ≥36 weeks through ≤44 weeks gestational age; this would constitute treatment Group II.
- Weight: subject's weight at the time of enrollment must be >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).
Who cannot join
- 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.
- Heart rate <120 bpm prior to the initiation of study drug.
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- Exposure to any investigational drug within 30 days prior to study drug administration.
- Previous exposure to Dexmedetomidine (DEX) as part of an investigational study.
- Maternal history of poly-substance drug abuse, based upon the presence of 1) an abnormal urine drug screen for cocaine, opiates and/or benzodiazepines; or 2) Investigator's judgment.
- At the discretion of the Investigator, subjects in whom the risk of DEX treatment is expected to exceed its benefits.
- Subjects who have a known allergy or contraindication to fentanyl, morphine, Midazolam, DEX, or other α-2 agonists.
- Requirement for medications other than DEX, Midazolam, morphine, or fentanyl for sedation and pain control.
- Screening alanine aminotransferase (ALT) levels >115 U/L.
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States17 sites
Akron Children's Hospital Medical Center
Akron, Ohio, 44308
Georgia Health Sciences University
Augusta, Georgia, 30912
Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Duke University Medical Center, Department of Anesthesiology
Durham, North Carolina, 27710
Study site
Greenville, South Carolina, 29605
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Miller Children's Hospital
Long Beach, California, 90806
Childrens Hospital Los Angeles
Los Angeles, California, 90027
Kosair Charities Pediatric Clinical Research Unit, University of Louisville
Louisville, Kentucky, 40202
Loyola University Medical Center
Maywood, Illinois, 60153
University of Miami - Miller School of Medicine, Department of Anesthesiology
Miami, Florida, 33136
West Virginia University School of Medicine
Morgantown, West Virginia, 26506
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
University of California San Francisco, Department of Pediatrics, Division of Neonatology
San Francisco, California, 94143-0734
Dept. of Anesthesia, SUMC
Stanford, California, 94305
Study site
Wichita, Kansas, 67214
About this study
Official title: A Phase II/III, Open-Label, Multicenter, Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Neonates Ages ≥28 Weeks to ≤44 Weeks Gestational Age
The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading dose followed by a continuous infusion for a minimum of 6 hours and up to 24 hours in the neonatal intensive care unit (NICU), cardiac intensive care unit (CICU), or pediatric intensive care unit (PICU).
- Conditions
- Sedation
- Being tested
- Midazolam, Fentanyl/Morphine, Dexmedetomidine
- Keywords
- Initially intubated and mechanically ventilated neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion
Fentanyl/MorphineDrug
Per package insert, N-PASS scores and investigator discretion.
DexmedetomidineDrug
Also called Precedex
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine 0.05 mcg/kg | Experimental | Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr. Receives: Drug: Midazolam; Drug: Fentanyl/Morphine; Drug: Dexmedetomidine |
| Dexmedetomidine 0.1 mcg/kg | Experimental | Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr. Receives: Drug: Midazolam; Drug: Fentanyl/Morphine; Drug: Dexmedetomidine |
| Dexmedetomidine 0.2 mcg/kg | Experimental | Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr. Receives: Drug: Midazolam; Drug: Fentanyl/Morphine; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion
Measured: During study drug administration (6 to 24 hours)
Secondary outcomes (8)
Percentage of Subjects Who Received Rescue Medication for Analgesia During Dexmedetomidine Infusion
Measured: During Study drug administration (6 to 24 hours)
Total Amount of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)
Measured: During Study drug administration (6 to 24 hours)
Total Amount of Rescue Medication Fentanyl Given for Sedation During Dexmedetomidine Infusion (Among Who Used)
Measured: During study drug administration (6 to 24 hours)
Total Amount of Rescue Medication Morphine Given for Sedation During Dexmedetomidine Infusion (Among Who Used)
Measured: During study drug administration (6 to 24 hours)
Weight-adjusted Total Amount (Per kg) of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)
Measured: During study drug administration (6 to 24 hours)
Weight-adjusted Total Amount (Per kg) of Rescue Medication Fentanyl Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)
Measured: During study drug administration (6 to 24 hours)
Weight-adjusted Total Amount (Per kg) of Rescue Medication Morphine Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)
Measured: During study drug administration (6 to 24 hours)
Time to Successful Extubation in DEX-exposed Subjects
Measured: From start of DEX administration to extubation of each subject up to 7 days post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159262
- Sponsor's protocol ID
- DEX-09-08
- Status last verified
- Jul 2015
- First submitted
- 30 Jun 2010
- Last updated
- 13 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Chrysostomou C, Schulman SR, Herrera Castellanos M, Cofer BE, Mitra S, da Rocha MG, Wisemandle WA, Gramlich L. A phase II/III, multicenter, safety, efficacy, and pharmacokinetic study of dexmedetomidine in preterm and term neonates. J Pediatr. 2014 Feb;164(2):276-82.e1-3. doi: 10.1016/j.jpeds.2013.10.002. Epub 2013 Nov 14.
PubMed 24238862
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III, Open-Label, Multicenter, Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Neonates Ages ≥28 Weeks to ≤44 Weeks Gestational Age
- ClinicalTrials.gov ID
- NCT01159262
- Acronym / sponsor ID
- DEX-09-08
- Conditions
- Sedation
- Keywords
- Initially intubated and mechanically ventilated neonates
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hospira, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 9 Jul 2010 (estimated)
- Results
- Posted 12 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading dose followed by a continuous infusion for a minimum of 6 hours and up to 24 hours in the neonatal intensive care unit (NICU), cardiac intensive care unit (CICU), or pediatric intensive care unit (PICU).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine 0.05 mcg/kg | Experimental | Drug: Midazolam, Drug: Fentanyl/Morphine, Drug: DexmedetomidineDexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr. |
| Dexmedetomidine 0.1 mcg/kg | Experimental | Drug: Midazolam, Drug: Fentanyl/Morphine, Drug: DexmedetomidineDexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr. |
| Dexmedetomidine 0.2 mcg/kg | Experimental | Drug: Midazolam, Drug: Fentanyl/Morphine, Drug: DexmedetomidineDexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr. |
Who may qualify
- Ages
- 28 to 44 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Initially intubated and mechanically ventilated pediatric subjects in an intensive care setting anticipated to require a minimum of 6 hours of continuous IV sedation.
- The ability to complete all PK sampling blood draws.
- Age: subjects must fit into 1 of the following age ranges at screening:
- Weight: subject's weight at the time of enrollment must be >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).
Key exclusion criteria (13 listed)
- Neonate subjects with neurological conditions that prohibit an evaluation of sedation such as:
- Subjects with second degree or third degree heart block unless subject has a pacemaker or pacing wires are in situ.
- Heart rate <120 bpm prior to the initiation of study drug.
- Exposure to any investigational drug within 30 days prior to study drug administration.
- Previous exposure to Dexmedetomidine (DEX) as part of an investigational study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamPer package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion | Drug | Dexmedetomidine 0.05 mcg/kg, Dexmedetomidine 0.1 mcg/kg, Dexmedetomidine 0.2 mcg/kg |
| Fentanyl/MorphinePer package insert, N-PASS scores and investigator discretion. | Drug | Dexmedetomidine 0.05 mcg/kg, Dexmedetomidine 0.1 mcg/kg, Dexmedetomidine 0.2 mcg/kg |
| DexmedetomidineAlso: Precedex | Drug | Dexmedetomidine 0.05 mcg/kg, Dexmedetomidine 0.1 mcg/kg, Dexmedetomidine 0.2 mcg/kg |
Primary outcome
Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion
Time frame: During study drug administration (6 to 24 hours)
8 secondary outcomes
Percentage of Subjects Who Received Rescue Medication for Analgesia During Dexmedetomidine Infusion
Time frame: During Study drug administration (6 to 24 hours)
Total Amount of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)
Time frame: During Study drug administration (6 to 24 hours)
Total Amount of Rescue Medication Fentanyl Given for Sedation During Dexmedetomidine Infusion (Among Who Used)
Time frame: During study drug administration (6 to 24 hours)
Total Amount of Rescue Medication Morphine Given for Sedation During Dexmedetomidine Infusion (Among Who Used)
Time frame: During study drug administration (6 to 24 hours)
Weight-adjusted Total Amount (Per kg) of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used)
Time frame: During study drug administration (6 to 24 hours)
Weight-adjusted Total Amount (Per kg) of Rescue Medication Fentanyl Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)
Time frame: During study drug administration (6 to 24 hours)
Weight-adjusted Total Amount (Per kg) of Rescue Medication Morphine Given for Analgesia During Dexmedetomidine Infusion (Among Who Used)
Time frame: During study drug administration (6 to 24 hours)
Time to Successful Extubation in DEX-exposed Subjects
Time frame: From start of DEX administration to extubation of each subject up to 7 days post-infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24238862Chrysostomou C, Schulman SR, Herrera Castellanos M, Cofer BE, Mitra S, da Rocha MG, Wisemandle WA, Gramlich L. A phase II/III, multicenter, safety, efficacy, and pharmacokinetic study of dexmedetomidine in preterm and term neonates. J Pediatr. 2014 Feb;164(2):276-82.e1-3. doi: 10.1016/j.jpeds.2013.10.002. Epub 2013 Nov 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Midazolam, Fentanyl/Morphine and Dexmedetomidine in people with Sedation, run by Hospira, now a wholly owned subsidiary of Pfizer at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion (time frame: During study drug administration (6 to 24 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01159262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.