Whole-Body Hypothermia for Neonates with Hypoxic–Ischemic Encephalopathy
Seetha Shankaran, M.D., Abbot R. Laptook, M.D., Richard A. Ehrenkranz, M.D., Jon E. Tyson, M.D., M.P.H., Scott A. McDonald, B.S., Edward F. Donovan, M.D., Avroy A. Fanaroff, M.D., W. Kenneth Poole, Ph.D., Linda L. Wright, M.D., Rosemary D. Higgins, M.D., Neil N. Finer, M.D., Waldemar A. Carlo, M.D., Shahnaz Duara, M.D., William Oh, M.D., C. Michael Cotten, M.D., David K. Stevenson, M.D., Barbara J. Stoll, M.D., James A. Lemons, M.D., Ronnie Guillet, M.D., Ph.D., Alan H. Jobe, M.D., Ph.D., for the National Institute of Child Health and Human Development Neonatal Research Network
Background Hypothermia is protective against brain injury afterasphyxiation in animal models. However, the safety and effectivenessof hypothermia in term infants with encephalopathy is uncertain.
Methods We conducted a randomized trial of hypothermia in infantswith a gestational age of at least 36 weeks who were admittedto the hospital at or before six hours of age with either severeacidosis or perinatal complications and resuscitation at birthand who had moderate or severe encephalopathy. Infants wererandomly assigned to usual care (control group) or whole-bodycooling to an esophageal temperature of 33.5°C for 72 hours,followed by slow rewarming (hypothermia group). Neurodevelopmentaloutcome was assessed at 18 to 22 months of age. The primaryoutcome was a combined end point of death or moderate or severedisability.
Results Of 239 eligible infants, 102 were assigned to the hypothermiagroup and 106 to the control group. Adverse events were similarin the two groups during the 72 hours of cooling. Primary outcomedata were available for 205 infants. Death or moderate or severedisability occurred in 45 of 102 infants (44 percent) in thehypothermia group and 64 of 103 infants (62 percent) in thecontrol group (risk ratio, 0.72; 95 percent confidence interval,0.54 to 0.95; P=0.01). Twenty-four infants (24 percent) in thehypothermia group and 38 (37 percent) in the control group died(risk ratio, 0.68; 95 percent confidence interval, 0.44 to 1.05;P=0.08). There was no increase in major disability among survivors;the rate of cerebral palsy was 15 of 77 (19 percent) in thehypothermia group as compared with 19 of 64 (30 percent) inthe control group (risk ratio, 0.68; 95 percent confidence interval,0.38 to 1.22; P=0.20).
Conclusions Whole-body hypothermia reduces the risk of deathor disability in infants with moderate or severe hypoxic–ischemicencephalopathy.
Source Information
From the Division of Neonatal–Perinatal Medicine, Wayne State University, Detroit (S.S.); Women's and Infant's Hospital, Providence, R.I. (A.R.L., W.O.); Yale University School of Medicine, New Haven, Conn. (R.A.E.); University of Texas at Houston, Houston (J.E.T.); Research Triangle Institute, Research Triangle Park, N.C. (S.A.M., W.K.P.); College of Medicine, University of Cincinnati, Cincinnati (E.F.D., A.H.J.); Rainbow Babies and Children's Hospital, Case Western University, Cleveland (A.A.F.); National Institute of Child Health and Human Development, Bethesda, Md. (L.L.W., R.D.H.); University of California at San Diego, San Diego (N.N.F.); University of Alabama, Birmingham (W.A.C.); Department of Pediatrics, University of Miami, Miami (S.D.); Duke University Medical Center, Durham, N.C. (C.M.C.); Stanford University School of Medicine, Palo Alto, Calif. (D.K.S.); Emory University School of Medicine, Atlanta (B.J.S.); Indiana University School of Medicine, Indianapolis (J.A.L.); and the University of Rochester, Rochester, N.Y. (R.G.).
Address reprint requests to Dr. Shankaran at the Division of Neonatal–Perinatal Medicine, Wayne State University, Children's Hospital of Michigan, 3901 Beaubien Blvd., Rm. 4H46, Detroit, MI 48201, or at sshankar{at}med.wayne.edu.
Hypothermia for Neonates with Hypoxic–Ischemic Encephalopathy
Polderman K. H., Girbes A. R.J., Nelson K. B., Leviton A., Gluckman P. D., Gunn A. J., Wyatt J. S., Shankaran S., Laptook A. R., the National Institute of Child Health and Human Development Neonatal Research Network
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N Engl J Med 2006;
354:1643-1645, Apr 13, 2006.
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