Open-Label, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥28 Weeks to <36 Weeks Gestational Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01508455
First received: January 5, 2012
Last updated: September 8, 2015
Last verified: September 2015
Results First Received: August 2, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Anesthesia
Interventions: Drug: Dexmedetomidine
Drug: Midazolam
Drug: Fentanyl
Drug: Morphine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Neonatal subjects enrolled from 3 centers in the United States

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Dexmedetomidine Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)

Participant Flow:   Overall Study
    Dexmedetomidine  
STARTED     6  
COMPLETED     6  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All subjects that received study drug.

Reporting Groups
  Description
Dexmedetomidine Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)

Baseline Measures
    Dexmedetomidine  
Number of Participants  
[units: participants]
  6  
Age  
[units: participants]
 
<=18 years     6  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: weeks]
Mean (Standard Deviation)
 
Age Continuous     0.8  (1.36)  
Age Continuous: units: Gestational Age     32.5  (2.74)  
Gender  
[units: participants]
 
Female     4  
Male     2  
Region of Enrollment  
[units: participants]
 
United States     6  



  Outcome Measures
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1.  Primary:   Percent of Subjects Requiring Rescue Midazolam for Sedation   [ Time Frame: During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours). ]

2.  Secondary:   Incidence of Rescue Medication (Fentanyl or Morphine) Use for Analgesia During DEX Infusion   [ Time Frame: During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours). ]

3.  Secondary:   Amount of Rescue Medication (Midazolam) for Sedation During Dexmedetomidine Infusion   [ Time Frame: During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours). ]

4.  Secondary:   Amount of Rescue Medication for Analgesia During DEX Infusion   [ Time Frame: During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours). ]

5.  Secondary:   Time Spent With a Total N-PASS Score >3 During DEX Infusion   [ Time Frame: Predose, loading dose (LD) 5 & 10mins/if LD is 20mins (5, 10, 15 & 20mins); maintenance infusion: 0 min, every 15mins (1st hr); every 30mins (2hrs), then hourly; within 5mins of DEX discontinuation; 5mins pre and post rescue medication ]

6.  Secondary:   Time to Successful Extubation   [ Time Frame: From the start of study drug infusion to the study completion/withdrawal (Approximately 48 hours) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Marcelo Garcia da Rocha
Organization: Hospira
phone: 224-212-4424
e-mail: marcelo.rocha@hospira.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hospira, Inc.
ClinicalTrials.gov Identifier: NCT01508455     History of Changes
Other Study ID Numbers: DEX-11-06
Study First Received: January 5, 2012
Results First Received: August 2, 2013
Last Updated: September 8, 2015
Health Authority: United States: Food and Drug Administration
Guatemala: Ministry of Public Health and Social Assistance