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Original Article Moderate Hypothermia to Treat Perinatal Asphyxial Encephalopathy Denis V. Azzopardi, F.R.C.P.C.H., Brenda Strohm, R.G.N., A. David Edwards, F.Med.Sci., Leigh Dyet, M.B., B.S., Ph.D., Henry L. Halliday, F.R.C.P.H., Edmund Juszczak, M.Sc., Olga Kapellou, M.D., Malcolm Levene, F.Med.Sci., Neil Marlow, F.Med.Sci., Emma Porter, M.R.C.P.C.H., Marianne Thoresen, M.D., Ph.D., Andrew Whitelaw, F.R.C.P.C.H., and Peter Brocklehurst, F.F.P.H., for the TOBY Study Group N Engl J Med 2009; 361:1349-1358 DOI: 10.1056/NEJMoa0900854. Results Of 325 infants enrolled, 163 underwent intensive care with cooling, and 162 underwent intensive care alone.
In the cooled group, 42 infants died and 32 survived but had severe neurodevelopmental disability, whereas in the noncooled group, 44 infants died and 42 had severe disability (relative risk for either outcome, 0.86; 95% confidence interval [CI], 0.68 to 1.07; P=0.17). Infants in the cooled group had an increased rate of survival without neurologic abnormality (relative risk, 1.57; 95% CI, 1.16 to 2.12; P=0.003).
Among survivors, cooling resulted in reduced risks of cerebral palsy (relative risk, 0.67; 95% CI, 0.47 to 0.96; P=0.03) and improved scores on the Mental Developmental Index and Psychomotor Developmental Index of the Bayley Scales of Infant Development II (P=0. Read Fantastic Beasts And Where To Find Them Pdf Viewer more. 03 for each) and the Gross Motor Function Classification System (P=0.01). Improvements in other neurologic outcomes in the cooled group were not significant.
Adverse events were mostly minor and not associated with cooling. Perinatal asphyxial encephalopathy is associated with high morbidity and mortality rates worldwide and is a major burden for the patient, the family, and society.
There is an urgent need to improve outcomes in affected infants. Experimentally, reducing body temperature to 3 to 5°C below the normal level reduces cerebral injury and improves neurologic function after asphyxia. Preliminary clinical studies have found no serious adverse effects of cooling.
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Two randomized, controlled trials, the CoolCap trial and the National Institute of Child Health and Human Development (NICHD) trial, have reported outcomes among infants at 18 months of age who had asphyxial encephalopathy, after slightly different cooling regimens. Only the NICHD trial showed a significant reduction in the composite primary outcome of death or disability with hypothermia. Neither trial had sufficient power to detect significant differences in important individual neurologic outcomes, and several systematic reviews and an expert workshop did not reach a consensus in recommending hypothermia as standard treatment. To clarify the role of hypothermia, we carried out the Total Body Hypothermia for Neonatal Encephalopathy Trial (TOBY), a multicenter, randomized trial comparing intensive care plus total-body cooling for 72 hours with intensive care without cooling among term infants with asphyxial encephalopathy. Study Design and Procedures TOBY was a randomized, controlled trial, involving term infants, comparing intensive care plus total-body cooling for 72 hours with intensive care without cooling. Infants were eligible if they were born at or after 36 completed weeks' gestation. They also had to have, at 10 minutes after birth, either an Apgar score of 5 or less or a continued need for resuscitation or, within 60 minutes after birth, acidosis (defined as any occurrence of umbilical-cord, arterial, or capillary pH of.