Status:
COMPLETED
Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
University of Maryland
Conditions:
Encephalopathy, Hypoxic-Ischemic
Eligibility:
All Genders
35-42 years
Phase:
PHASE1
PHASE2
Brief Summary
This research is being done to find out the safety of the investigational study drug, Clonidine Hydrochloride ( CLON). , in infants who are undergoing whole body cooling for the treatment of hypoxic i...
Detailed Description
The most desirable sedative-analgesic agent used in infants with HIE would 1) have an excellent safety profile, 2) provide adequate analgesia and sedation, 3) reduce shivering, 4) cause minimal respir...
Eligibility Criteria
Inclusion
- Infants ≥35 0/7 weeks gestation with the diagnosis of HIE who are being treated with therapeutic hypothermia, who have indwelling arterial lines
- Informed parental consent
Exclusion
- Infants who are considered moribund and the clinical team is considering withdrawal of support
- Infants who need \> 20 µg/kg/min of dopamine or the addition of epinephrine or dobutamine to maintain a mean arterial pressure (MAP) ≥ 45 mmHg, or milrinone for cardiovascular support
- Baseline heart rate (HR) \<80 bpm during hypothermia
- Infants suspected of major chromosomal anomalies, except trisomy 21
- Infants with major cardiovascular anomalies
- Infants with severe persistent pulmonary hypertension of the newborn who are enrolled and who then need Extracorporal Membrane Oxygenation (ECMO) will be withdrawn from the study
Key Trial Info
Start Date :
October 3 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01862250
Start Date
October 3 2013
End Date
April 14 2015
Last Update
January 5 2018
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287