New 2010 neonatal resuscitation guidelines state that offering therapeutic hypothermia (TH) should be a standard of care in managing neonates with perinatal hypoxic - ischemic insult and present with signs of moderate and/or severe hypoxic - ischemic encephalopathy (HIE) . Despite the evidence from several randomized control trial (RCT) proving its effectiveness, its effect is perceived insufficient or only modest. Thus today's research efforts are directed toward finding the new possibilities of enhancing the effects of hypothermia. List of agents with potential neuroprotective properties includes: erythropoetin, melatonin, topiramate, morphine, xenon, MgSO4. Given investigators previous experiences with preterm neonates exposed to MgSO4 prenatally or administered this drug after birth because of perinatal asphyxia, the investigators designed the trial which would evaluate the possibility of increasing the TH effect by combining this method with MgSO4. Until now there are several published studies evaluating the effectiveness of MgSO4 in the group of asphyxiated neonates, including one RCT. However, all of these studies were conducted before the era of TH Furthermore, irrespective of the potential benefits, safety of using MgSO4 during TH in the group of term neonates was not studied. It is particularly important in the light of the results presented by Mittendorf et.al. They studied the effects of prenatal aggressive treatment with MgSO4 on the outcome of preterm neonates showed that patients exposed to high doses of MgSO4 were at higher risk of severe intracranial bleeding. Other side effects of high serum magnesium levels are: vasodilatation, hypotension, cardiac arrhythmias, coagulopathy, and gastrointestinal disturbances. MgSO4 is a very attractive neuroprotective option,also because of its easy availability. Drug can be administered in the birth hospital while neonate is being prepared for the transport to TH center. Timing of the intervention is very important for neonates suffering from perinatal asphyxia. Both TH and administration of potentially neuroprotective drug should be started during "therapeutic window". It is the initial potentially reversible phase of hypoxic insult lasting about 6 hours. If the long-term follow up shows that MgSO4 has an additive neuroprotective effect and no significant side effects in the group of asphyxiated neonates treated with TH this relatively simple and not expensive intervention may be introduced into clinical practice
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Death
Timeframe: until discharge (participants will be followed for the duration of hospital stay @ hypothermia center, an expected up to 4 weeks