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Trial record 6 of 326 for:    clonidine

Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia (HIE)

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ClinicalTrials.gov Identifier: NCT01862250
Recruitment Status : Completed
First Posted : May 24, 2013
Results First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Collaborator:
University of Maryland, College Park
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Encephalopathy, Hypoxic-Ischemic
Intervention Drug: Clonidine (Duraclon®)
Enrollment 13
Recruitment Details  
Pre-assignment Details Study medication was not administered for one participant
Arm/Group Title Clonidine Infants With HIE
Hide Arm/Group Description

Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming

Clonidine (Duraclon®): Clonidine at dosing intervals of 6, 8, 12, 18 or 24 hours.

If the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.

  • 10 mm Hg reduction in Mean Arterial Pressure (MAP) or MAP ≤ 40 mm Hg sustained for ≥30 min after administration
  • 20% drop in Heart Rate (HR) from the infant's baseline, sustained for ≥30 min after administration
  • HR ≤70/min, sustained for ≥30 min after administration
Period Title: Overall Study
Started 12
Completed 8
Not Completed 4
Reason Not Completed
Adverse Event             4
Arm/Group Title Clonidine Infants With HIE
Hide Arm/Group Description

Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming

Clonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.

If the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.

  • 10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration
  • 20% drop in HR from the infant's baseline, sustained for ≥30 min after administration
  • HR ≤70/min, sustained for ≥30 min after administration
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Weeks
Number Analyzed 12 participants
38.2
(35.9 to 39.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
6
  50.0%
Male
6
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  33.3%
White
8
  66.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Steady State Clonidine Blood Levels During Hypothermia
Time Frame 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Only 8 babies were assessed for this outcome because the rest did not have a steady state trough level performed during cooling
Arm/Group Title Clonidine Infants With HIE
Hide Arm/Group Description:

Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming

Clonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.

If the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.

  • 10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration
  • 20% drop in HR from the infant's baseline, sustained for ≥30 min after administration
  • HR ≤70/min, sustained for ≥30 min after administration
Overall Number of Participants Analyzed 8
Median (Full Range)
Unit of Measure: ng/ml
0.6
(0.27 to 1.06)
2.Primary Outcome
Title Amount of Morphine Given
Hide Description Intravenous morphine (mg/kg) was given. The standard dose is 0.05 mg/kg per dose
Time Frame Up to 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clonidine Infants With HIE
Hide Arm/Group Description:

Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming

Clonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.

If the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.

  • 10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration
  • 20% drop in HR from the infant's baseline, sustained for ≥30 min after administration
  • HR ≤70/min, sustained for ≥30 min after administration
Overall Number of Participants Analyzed 8
Median (Inter-Quartile Range)
Unit of Measure: mg/kg
0.02
(0.00 to 0.08)
3.Secondary Outcome
Title Presence of Shivering After Clonidine
Hide Description Babies were assessed after administration of clonidine for the presence or absence of shivering.
Time Frame 48hrs
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clonidine Infants With HIE
Hide Arm/Group Description:

Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming

Clonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.

If the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.

  • 10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration
  • 20% drop in HR from the infant's baseline, sustained for ≥30 min after administration
  • HR ≤70/min, sustained for ≥30 min after administration
Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Secondary Outcome
Title Time to Passive Rewarming
Hide Description Following 2 hours of therapeutic hypothermia, the temperature of the thermo-blanket is adjusted up half degree per hour allowing passive rewarming until 36.5 degrees is reached
Time Frame Beginning at 72 hours up to 12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clonidine Infants With HIE
Hide Arm/Group Description:

Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming

Clonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.

If the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.

  • 10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration
  • 20% drop in HR from the infant's baseline, sustained for ≥30 min after administration
  • HR ≤70/min, sustained for ≥30 min after administration
Overall Number of Participants Analyzed 8
Median (Inter-Quartile Range)
Unit of Measure: Hours
8.7
(7.4 to 10.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clonidine Infants With HIE
Hide Arm/Group Description

Infants in this group will receive Intravenous clonidine at 1µg/kg/dose either every 6 or 8 hrs from the start of cooling to the end of re-warming

Clonidine (Duraclon®): Clonidine at dosing intervals of 4, 6, 8, 12, 18 or 24 hours.

If the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.

  • 10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration
  • 20% drop in HR from the infant's baseline, sustained for ≥30 min after administration
  • HR ≤70/min, sustained for ≥30 min after administration
All-Cause Mortality
Clonidine Infants With HIE
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Clonidine Infants With HIE
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clonidine Infants With HIE
Affected / at Risk (%)
Total   0/12 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Estelle B. Gauda
Organization: University of Toronto
Phone: 416-813-4908
EMail: estelle.gauda@sickkids.ca
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01862250     History of Changes
Obsolete Identifiers: NCT02252848
Other Study ID Numbers: ID: NA_00072308
First Submitted: April 1, 2013
First Posted: May 24, 2013
Results First Submitted: October 19, 2017
Results First Posted: January 5, 2018
Last Update Posted: January 5, 2018