| Perinatal hypoxia-ischemia brain damage (HIBD) remains a major cause of acute mortability and chronic neurological morbidity in infants and children despite marked improvements in perinatal practice. The mechanisms of brain injury are not completely understood. Up to now, although many therapeutic strategies have been evaluated in animals, none of them have been proven clinically effective in reducing harmful effects of HIBD except of hypothermia. However, this method has not been accepted by most of pediatrians. The purpose of this study was to evaluate the safety and effect of systemic hypothermia on neonatal HIBD.MethodsThirty-two asphyxiated newboms from Aug. 2002 to Oct. 2003 were enrolled this study in our NICU who fulfilled the following criteria: (1). Gestation age >37 week's, body weight >2.5kg. (2) with one of the following factors : (1)Apgar score <3 at 1min , <5 at 5min ; (2) Assisted respiration >min due to respiratory distress; (3) pH 7.1 of cord or arterial blood in 60min after birth ; (4)Clinical manifestation of encephalopathy during the first 6h of life; (3) Severe congenital abnormities, hemorrhage and infections were excluded . The infants were randomized to either systemic hypothermia group (n = 16) or control group (n = 16). The infants in hypothermia group were got parental consent and maintained rectal temperature33.0-34.0'C for 72h by cooling device. The supportive treatments were the same in both groups. Heart rate, blood pressure, respiratory rate, rectal temperature, consciousness, oxygen saturation, skin lesion, blood glucose, blood gases, blood electrolytes, coagulation parameters, platelet, renal (Bun + Cr) and liver function (ALT + AST) , neuron-specific enolase (NSE) and S-100 protein in blood and CSF were all monitored. Clinical follow-up include: Neonatal Behavioral Neurological Assessment (NBNA) was evaluated on postnatal day 7, 14 , 28, Brain CT was re-examined at 1 month and intellectual development index was evaluated at 3 month > 6 month by using Intellectual Development Table made by Children's Development Center of China (CDCC).Results(1) vital signs: (1)Heart rate was decreased about 30 beats / min in hypothermia group during hypothermia treatment with a rectal temperature around 33.5 C, which was significantly lower than that of control group. Heart rate increased gradually with the recovery of body temperature. Cardiac arrhythmia, bradycardia or other serious symptoms were not observed during the process of hypothermia. (2)Respiration was steady. Apnea and blood oxygen-saturation descent was not occurred. (3)There was no hypothermia related to changes in blood pressure during treatment though the blood pressure was lightly lower in the hypothermia group during recovery after hypothermia.(2) Coagulation: Both plasminogen time (PT) and thrombin time (TT) were prolonged in all infants after birth. These abnormalities were corrected at 96h after treatment. Platelet counts had no significantly differences between hypothermia group and control group(3)Blood glucose and electrolytes: Blood glucose in both groups was decreased before treatment and recovered to the normal level after supportive treatment. No hypothermia treatment related blood glucose change was observed. The blood natrium, calcium was lower than that of normal level before treatment and were normal at 96h after supportive treatment. All the electrolytes in both groups were no significant2004difference.(4)Blood gas: All the asphyxia infants had metabolic acidosis before treatment and were gradually corrected after therapy. There was no hypothermia related acidosis was found.(5)Renal and liver function: All infants had acute renal and liver insufficiency before treatment because of asphyxia and all the parameters of renal and liver function were recovered after supportive treatment in both groups. Side effect of hypothermia on renal and liver function was not found.(6)Clinical observation: No hypothermia treatment related bleeding, infection, pulmonary hemorrhage, necrotizing enterocol...
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