Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia
Status:
Completed
Trial end date:
2015-04-14
Target enrollment:
Participant gender:
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 ischemic encephalopathy (HIE). The only known and effective treatment
for HIE is therapeutic hypothermia or whole body cooling for72 hours. During the cooling
process, babies get agitated, shiver and are uncomfortable. To treat these side effects
morphine is frequently used. CLON is very effective in decreasing shivering in adults and
children. Furthermore, in some preclinical studies, clonidine has been shown to be
neuroprotective (safe for the brain in models of brain injury)..This is a Phase I-II to
determine if low dose CLON will reduce the incidence of shivering and whether it has short
term cardiovascular safety. In this Phase I-II study, the investigators will determine the
(i) the maximum tolerated dose of CLON during cooling for HIE, (ii) the effects of CLON on
heart rate, blood pressure, core body temperature and cerebral autoregulation (ability to
maintain constant blood flow to the brain) and (iii) association between blood levels and
changes in the above parameters. In this study the investigators hope to find ways to improve
sedation, shivering and agitation in newborn infants with HIE on the cooling protocol. Our
ultimate goal is determine the potential neuro-protective properties of clonidine in newborn
babies with HIE.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Estelle B. Gauda, MD Johns Hopkins University
Collaborators:
University of Maryland University of Maryland, College Park