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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine 0.05 mcg/kg | Experimental | Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr. |
|
| Dexmedetomidine 0.1 mcg/kg | Experimental | Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr. |
|
| Dexmedetomidine 0.2 mcg/kg | Experimental | Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion | During study drug administration (6 to 24 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Who Received Rescue Medication for Analgesia During Dexmedetomidine Infusion | During Study drug administration (6 to 24 hours) | |
| Total Amount of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used) |
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Inclusion Criteria:
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).
Exclusion Criteria:
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.
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | United States | ||
| Miller Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24238862 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine 0.05 mcg/kg | Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr. Midazolam: Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion Fentanyl: Per package insert, N-PASS scores and investigator discretion. Dexmedetomidine |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Fentanyl/Morphine | Drug | Per package insert, N-PASS scores and investigator discretion. |
|
| Dexmedetomidine | Drug |
|
|
| During Study drug administration (6 to 24 hours) |
| Total Amount of Rescue Medication Fentanyl Given for Sedation During Dexmedetomidine Infusion (Among Who Used) | During study drug administration (6 to 24 hours) |
| Total Amount of Rescue Medication Morphine Given for Sedation During Dexmedetomidine Infusion (Among Who Used) | 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) | 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) | 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) | During study drug administration (6 to 24 hours) |
| Time to Successful Extubation in DEX-exposed Subjects | From start of DEX administration to extubation of each subject up to 7 days post-infusion |
| Long Beach |
| California |
| 90806 |
| United States |
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| University of California San Francisco, Department of Pediatrics, Division of Neonatology | San Francisco | California | 94143-0734 | United States |
| Dept. of Anesthesia, SUMC | Stanford | California | 94305 | United States |
| University of Miami - Miller School of Medicine, Department of Anesthesiology | Miami | Florida | 33136 | United States |
| Georgia Health Sciences University | Augusta | Georgia | 30912 | United States |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Wichita | Kansas | 67214 | United States |
| Kosair Charities Pediatric Clinical Research Unit, University of Louisville | Louisville | Kentucky | 40202 | United States |
| Duke University Medical Center, Department of Anesthesiology | Durham | North Carolina | 27710 | United States |
| Akron Children's Hospital Medical Center | Akron | Ohio | 44308 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | United States |
| Greenville | South Carolina | 29605 | United States |
| West Virginia University School of Medicine | Morgantown | West Virginia | 26506 | United States |
| Zona 11 Guatemala | C.P. 01011 | Guatemala |
| Dexmedetomidine 0.1 mcg/kg |
Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr. Midazolam: Per package insert, N-PASS scores and investigator discretion Fentanyl: Per package insert, N-PASS scores and investigator discretion. Dexmedetomidine |
| FG002 | Dexmedetomidine 0.2 mcg/kg | Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr. Midazolam: Per package insert, N-PASS scores and investigator discretion Fentanyl: Per package insert, N-PASS scores and investigator discretion. Dexmedetomidine |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine 0.05 mcg/kg | Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr. Midazolam: Per package insert, N-PASS scores and investigator discretion Fentanyl: Per package insert, N-PASS scores and investigator discretion. Dexmedetomidine |
| BG001 | Dexmedetomidine 0.1 mcg/kg | Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr. Midazolam: Per package insert, N-PASS scores and investigator discretion Fentanyl: Per package insert, N-PASS scores and investigator discretion. Dexmedetomidine |
| BG002 | Dexmedetomidine 0.2 mcg/kg | Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr. Midazolam: Per package insert, N-PASS scores and investigator discretion Fentanyl: Per package insert, N-PASS scores and investigator discretion. Dexmedetomidine |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | weeks |
| |||||||||||||||
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion | Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours. | Posted | Number | percentage of subjects | During study drug administration (6 to 24 hours) |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Who Received Rescue Medication for Analgesia During Dexmedetomidine Infusion | Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours. | Posted | Number | percentage of subjects | During Study drug administration (6 to 24 hours) |
| |||||||||||||||||||||||||||||||||||
| Secondary | Total Amount of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used) | All subjects who received midazolam during Dexmedetomidine infusion | Posted | Mean | Standard Deviation | Milligram | During Study drug administration (6 to 24 hours) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Total Amount of Rescue Medication Fentanyl Given for Sedation During Dexmedetomidine Infusion (Among Who Used) | All subjects who received fentanyl during Dexmedetomidine infusion | Posted | Mean | Standard Deviation | Microgram | During study drug administration (6 to 24 hours) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Total Amount of Rescue Medication Morphine Given for Sedation During Dexmedetomidine Infusion (Among Who Used) | All subjects who received morphine during Dexmedetomidine infusion | Posted | Mean | Standard Deviation | milligram | During study drug administration (6 to 24 hours) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Weight-adjusted Total Amount (Per kg) of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used) | All subjects who received midazolam during Dexmedetomidine infusion | Posted | Mean | Standard Deviation | milligrams/Kg | During study drug administration (6 to 24 hours) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Weight-adjusted Total Amount (Per kg) of Rescue Medication Fentanyl Given for Analgesia During Dexmedetomidine Infusion (Among Who Used) | All subjects who received fentanyl during Dexmedetomidine infusion | Posted | Mean | Standard Deviation | microgram/Kg | During study drug administration (6 to 24 hours) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Weight-adjusted Total Amount (Per kg) of Rescue Medication Morphine Given for Analgesia During Dexmedetomidine Infusion (Among Who Used) | All subjects who received morphine during Dexmedetomidine infusion | Posted | Mean | Standard Deviation | milligram/Kg | During study drug administration (6 to 24 hours) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to Successful Extubation in DEX-exposed Subjects | Efficacy Evaluable Population: All subjects who received randomized Dexmedetomidine for at least 6 hours. | Posted | Median | 95% Confidence Interval | hour | From start of DEX administration to extubation of each subject up to 7 days post-infusion |
|
Start of study drug administration until 7 days following the start of study drug. Serious adverse events collected from signing of informed consent until 7 days following start of study drug administration or hospital discharge (whichever comes first).
Patients were monitored for safety parameters from 6 to 24 hours in the ICU.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexmedetomidine 0.05 mcg/kg | Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr. Midazolam: Per package insert, N-PASS scores and investigator discretion Fentanyl: Per package insert, N-PASS scores and investigator discretion. Dexmedetomidine | 0 | 14 | 7 | 14 | ||
| EG001 | Dexmedetomidine 0.1 mcg/kg | Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr. Midazolam: Per package insert, N-PASS scores and investigator discretion Fentanyl: Per package insert, N-PASS scores and investigator discretion. Dexmedetomidine | 1 | 14 | 9 | 14 | ||
| EG002 | Dexmedetomidine 0.2 mcg/kg | Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr. Midazolam: Per package insert, N-PASS scores and investigator discretion Fentanyl: Per package insert, N-PASS scores and investigator discretion. Dexmedetomidine | 0 | 8 | 6 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (13.0) | Non-systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA (13.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Patent ductus arteriosus | Congenital, familial and genetic disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Edema | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hyperbiliruninaemia | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abscess neck | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Shunt stenosis | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Blood bilirubin unconjugated increased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Hemoglobin decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Anger | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Atelectasis neonatal | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Plueral effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Diastolic hypotension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marcelo Garcia de Rocha MD, Global Medical Director | Hospira | 224-212-4424 | marcelo.rocha@hospira.com |
| ID | Term |
|---|---|
| D008874 | Midazolam |
| D005283 | Fentanyl |
| D009020 | Morphine |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
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| Between 18 and 65 years |
|
| >=65 years |
|
| >= 36 weeks to <= 44 weeks gestational age |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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