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: October 18, 2013
Last verified: October 2013
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: 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
No text entered.

Reporting Groups
  Description
DEX 0.2 LD / 0.2 MD LD – Loading Dose (mg/kg) MD – Maintenance Dose (mg/kg/hr)

Participant Flow:   Overall Study
    DEX 0.2 LD / 0.2 MD  
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
DEX 0.2 LD / 0.2 MD LD – Loading Dose (mg/kg) MD – Maintenance Dose (mg/kg/hr)

Baseline Measures
    DEX 0.2 LD / 0.2 MD  
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

1.  Primary:   Percent of Subjects Requiring Rescue Midazolam for Sedation   [ Time Frame: Subjects were followed for an average of 14.25 hours ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


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


No publications provided by Hospira, Inc.

Publications automatically indexed to this study:

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: October 18, 2013
Health Authority: United States: Food and Drug Administration
Guatemala: Ministry of Public Health and Social Assistance