Cited by 2,862Neonatal and fetal brain pathologyThermal Regulation in MedicineInfant Development and Preterm Care

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Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy

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Shankaran, Seetha, Laptook, Abbot R., Ehrenkranz, Richard A., Tyson, Jon E., McDonald, Scott A., Donovan, Edward F., Fanaroff, Avroy A., Poole, W. Kenneth, Wright, Linda L., Higgins, Rosemary D., Finer, Neil N., Carlo, Waldemar A., Duara, Shahnaz, Oh, William, Cotten, C. Michael, Stevenson, David K., Stoll, Barbara J., Lemons, James A., Guillet, Ronnie, Jobe, Alan H.·2005·New England Journal of Medicine

DOI 10.1056/nejmcps050929

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Abstract

BACKGROUND: Hypothermia is protective against brain injury after asphyxiation in animal models. However, the safety and effectiveness of hypothermia in term infants with encephalopathy is uncertain. METHODS: We conducted a randomized trial of hypothermia in infants with a gestational age of at least 36 weeks who were admitted to the hospital at or before six hours of age with either severe acidosis or perinatal complications and resuscitation at birth and who had moderate or severe encephalopathy. Infants were randomly assigned to usual care (control group) or whole-body cooling to an esophageal temperature of 33.5 degrees C for 72 hours, followed by slow rewarming (hypothermia group). Neurodevelopmental outcome was assessed at 18 to 22 months of age. The primary outcome was a combined end point of death or moderate or severe disability. RESULTS: Of 239 eligible infants, 102 were assigned to the hypothermia group and 106 to the control group. Adverse events were similar in the two groups during the 72 hours of cooling. Primary outcome data were available for 205 infants. Death or moderate or severe disability occurred in 45 of 102 infants (44 percent) in the hypothermia group and 64 of 103 infants (62 percent) in the control group (risk ratio, 0.72; 95 percent confidence interval, 0.54 to 0.95; P=0.01). Twenty-four infants (24 percent) in the hypothermia 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 the hypothermia group as compared with 19 of 64 (30 percent) in the 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 death or disability in infants with moderate or severe hypoxic-ischemic encephalopathy.

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Effect of Depth and Duration of Cooling on Death or Disability at Age 18 Months Among Neonates With Hypoxic-Ischemic Encephalopathy
Shankaran, S., Laptook, A. R., Pappas, A., McDonald, S. A., Das, A., Tyson, J. E., Poindexter, B. B., Schibler, K. R., Bell, E. F., Heyne, R. J., et al. (2017) · JAMA · doi:10.1001/jama.2017.7218 · Cited by 266
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Intervention strategies for neonatal hypoxic-ischemic cerebral injury
Perlman, J. M. (2006) · Clinical Therapeutics · doi:10.1016/j.clinthera.2006.09.005 · Cited by 265
2005 American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC) of Pediatric and Neonatal Patients: Neonatal Resuscitation Guidelines
American Heart Association, A. A. O. P. (2006) · PEDIATRICS · doi:10.1542/peds.2006-0349 · Cited by 263
A novel magnetic resonance imaging score predicts neurodevelopmental outcome after perinatal asphyxia and therapeutic hypothermia
Weeke, L. C., Groenendaal, F., Mudigonda, K., Blennow, M., Lequin, M. H., Meiners, L. C., van Haastert, I. C., Benders, M. J., Hallberg, B., & de Vries, L. S. (2018) · The Journal of Pediatrics · doi:10.1016/j.jpeds.2017.09.043 · Cited by 260
Pathophysiology and Treatment of Septic Shock in Neonates
Wynn, J. L., & Wong, H. R. (2010) · Clinics in Perinatology · doi:10.1016/j.clp.2010.04.002 · Cited by 260
Pharmacological Blockade of the Cold Receptor TRPM8 Attenuates Autonomic and Behavioral Cold Defenses and Decreases Deep Body Temperature
Almeida, M. C., Hew‐Butler, T., Soriano, R. N., Rao, S. P., Wang, W., Wang, L., Tamayo, N. A., de Oliveira, D. L., Nucci, T. B., Aryal, P., et al. (2012) · Journal of Neuroscience · doi:10.1523/jneurosci.5606-11.2012 · Cited by 254
Melatonin augments hypothermic neuroprotection in a perinatal asphyxia model
Robertson, N. J., Faulkner, S. D., Fleiss, B., Bainbridge, A. P., Andorka, C., Price, D., Powell, E., Lecky-Thompson, L., Thei, L., Chandrasekaran, M., et al. (2012) · Brain · doi:10.1093/brain/aws285 · Cited by 256
Epidemiology of cerebral palsy
Blair, E. M., & Watson, L. C. (2005) · Seminars in Fetal and Neonatal Medicine · doi:10.1016/j.siny.2005.10.010 · Cited by 253
Biomarkers for Severity of Neonatal Hypoxic-Ischemic Encephalopathy and Outcomes in Newborns Receiving Hypothermia Therapy
Chalak, L. F., Sánchez, P. J., ADAMS-HUET, B. A., Laptook, A. R., Heyne, R. J., & Rosenfeld, C. R. (2013) · The Journal of Pediatrics · doi:10.1016/j.jpeds.2013.10.067 · Cited by 247
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Comparison of hypothermia and normothermia after severe traumatic brain injury in children (Cool Kids): a phase 3, randomised controlled trial
Adelson, P. D., Wisniewski, S. R., Beca, J., Brown, S. D., Bell, M. J., Muizelaar, J. P., Okada, P. J., Beers, S. R., Balasubramani, G. K., & Hirtz, D. (2013) · The Lancet Neurology · doi:10.1016/s1474-4422(13)70077-2 · Cited by 247
Hypothermic neuroprotection
Gunn, A. J., & Thoresen, M. (2006) · NeuroRx · doi:10.1016/j.nurx.2006.01.007 · Cited by 245
Bumetanide for the treatment of seizures in newborn babies with hypoxic ischaemic encephalopathy (NEMO): an open-label, dose finding, and feasibility phase 1/2 trial
Pressler, R., Boylan, G. B., Marlow, N., Blennow, M., Chiron, C., Cross, J. H., de Vries, L. S., Hallberg, B., Hellström-Westas, L. K., Jullien, V., et al. (2015) · The Lancet Neurology · doi:10.1016/s1474-4422(14)70303-5 · Cited by 243
Xenon and Hypothermia Combine Additively, Offering Long-Term Functional and Histopathologic Neuroprotection After Neonatal Hypoxia/Ischemia
Hobbs, C., Thoresen, M., Tucker, A. M., Aquilina, K., Chakkarapani, E., & Dingley, J. (2008) · Stroke · doi:10.1161/strokeaha.107.499822 · Cited by 241
Part 10: Pediatric Basic and Advanced Life Support
Kleinman, M. E., de Caen, A. R., Chameides, L., Atkins, D. L., Berg, R. A., Berg, M., Bhanji, F., Biarent, D., Bingham, R. M., Coovadia, A. H., et al. (2010) · Circulation · doi:10.1161/circulationaha.110.971093 · Cited by 249
Multicenter cohort study of in-hospital pediatric cardiac arrest*
Meert, K. L., Donaldson, A., Nadkarni, V., Tieves, K. S., Schleien, C. L., Brilli, R. J., Clark, R. S. B., Shaffner, D. H., Levy, F. H., Statler, K. D., et al. (2009) · Pediatric Critical Care Medicine · doi:10.1097/pcc.0b013e3181a7045c · Cited by 235
Diagnosis, Treatment, and Prevention of Cerebral Palsy
O’Shea, T. M. (2008) · Clinical Obstetrics & Gynecology · doi:10.1097/grf.0b013e3181870ba7 · Cited by 263
Plasticity and injury in the developing brain
Johnston, M. V., Ishida, A., Nakajima, W., Matsushita, H., Nishimura, A., & Tsuji, M. (2008) · Brain and Development · doi:10.1016/j.braindev.2008.03.014 · Cited by 243
Brain-immune interactions in perinatal hypoxic-ischemic brain injury
Li, B., Concepcion, K. R., Meng, X., & Zhang, L. (2017) · Progress in Neurobiology · doi:10.1016/j.pneurobio.2017.10.006 · Cited by 236
Targeted Neonatal Echocardiography in the Neonatal Intensive Care Unit: Practice Guidelines and Recommendations for Training: Writing group of the American Society of Echocardiography (ASE) in collaboration with the European Association of Echocardiography (EAE) and the Association for European Pediatric Cardiologists (AEPC)
Mertens, L., Seri, I., Marek, J., Arlettaz, R., Barker, P. C. A., McNamara, P. J., Moon‐Grady, A. J., Coon, P. D., Noori, S., Simpson, J. M., et al. (2011) · European Journal of Echocardiography · doi:10.1093/ejechocard/jer181 · Cited by 228
High-Dose Erythropoietin and Hypothermia for Hypoxic-Ischemic Encephalopathy: A Phase II Trial
Wu, Y. W., Mathur, A., Chang, T., McKinstry, R. C., Mulkey, S. B., Mayock, D. E., Meurs, K. P. V., Rogers, E. E., Gonzalez, F. F., Comstock, B. A., et al. (2016) · PEDIATRICS · doi:10.1542/peds.2016-0191 · Cited by 227
Brain injury following trial of hypothermia for neonatal hypoxic–ischaemic encephalopathy
Shankaran, S., Barnes, P. D., Hintz, S. R., Laptook, A. R., Zaterka-Baxter, K. M., McDonald, S. A., Ehrenkranz, R. A., Walsh, M. C., Tyson, J. E., Donovan, E. F., et al. (2012) · Archives of Disease in Childhood Fetal & Neonatal · doi:10.1136/archdischild-2011-301524 · Cited by 225
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Acute Kidney Injury in Asphyxiated Newborns Treated with Therapeutic Hypothermia
Selewski, D. T., Jordan, B. K., Askenazi, D. J., Dechert, R. E., & Sarkar, S. (2012) · The Journal of Pediatrics · doi:10.1016/j.jpeds.2012.10.002 · Cited by 222
Neonatal hypoxic ischemic encephalopathy: an update on disease pathogenesis and treatment
Yıldız, E. P., Ekici, B., & Tatlı, B. (2016) · Expert Review of Neurotherapeutics · doi:10.1080/14737175.2017.1259567 · Cited by 220
Melatonin Reduces Inflammation and Cell Death in White Matter in the Mid-Gestation Fetal Sheep Following Umbilical Cord Occlusion
Welin, A.-K., Svedin, P., Lapatto, R., Sultan, B., Hagberg, H., Gressèns, P., Kjellmer, I., & Mallard, C. E. (2007) · Pediatric Research · doi:10.1203/01.pdr.0000252546.20451.1a · Cited by 219
Hypothermia and Other Treatment Options for Neonatal Encephalopathy: An Executive Summary of the Eunice Kennedy Shriver NICHD Workshop
Higgins, R. D., Raju, T. N. K., Edwards, A. D., Azzopardi, D., Bose, C. L., Clark, R. H., Ferriero, D. M., Guillet, R., Gunn, A. J., Hagberg, H., et al. (2011) · The Journal of Pediatrics · doi:10.1016/j.jpeds.2011.08.004 · Cited by 219
Self-citation
Electroencephalographic monitoring during hypothermia after pediatric cardiac arrest
Abend, N. S., Topjian, A., Ichord, R., Herman, S. T., Helfaer, M. A., Donnelly, M., Nadkarni, V., Dlugos, D., & Clancy, R. R. (2009) · Neurology · doi:10.1212/wnl.0b013e3181a82687 · Cited by 218
Neurological implications of urea cycle disorders
Gropman, A. L., Summar, M. L., & Leonard, J. V. (2007) · Journal of Inherited Metabolic Disease · doi:10.1007/s10545-007-0709-5 · Cited by 219
Multiple interacting cell death mechanisms in the mediation of excitotoxicity and ischemic brain damage: A challenge for neuroprotection
Puyal, J., Ginet, V., & Clarke, P. G. H. (2013) · Progress in Neurobiology · doi:10.1016/j.pneurobio.2013.03.002 · Cited by 224
Neonatal seizures
Silverstein, F. S., & Jensen, F. E. (2007) · Annals of Neurology · doi:10.1002/ana.21167 · Cited by 216
Elevated Temperature After Hypoxic-Ischemic Encephalopathy: Risk Factor for Adverse Outcomes
Laptook, A. R., Tyson, J. E., Shankaran, S., McDonald, S. A., Ehrenkranz, R. A., Fanaroff, A. A., Donovan, E. F., Goldberg, R. N., O’Shea, T. M., Higgins, R. D., et al. (2008) · PEDIATRICS · doi:10.1542/peds.2007-1673 · Cited by 213
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Perinatal Hypoxic‐Ischemic Encephalopathy
Lai, M., & Yang, S. (2010) · BioMed Research International · doi:10.1155/2011/609813 · Cited by 225
Central control of body temperature
Morrison, S. F. (2016) · F1000Research · doi:10.12688/f1000research.7958.1 · Cited by 210
Hypothermia: a systematic review and meta-analysis of clinical trials
Shah, P. S. (2010) · Seminars in Fetal and Neonatal Medicine · doi:10.1016/j.siny.2010.02.003 · Cited by 207
Erythropoietin for Neuroprotection in Neonatal Encephalopathy: Safety and Pharmacokinetics
Wu, Y. W., Bauer, L. A., Ballard, R. A., Ferriero, D. M., Glidden, D. V., Mayock, D. E., Chang, T., Durand, D. J., Song, D., Bonifacio, S. L., et al. (2012) · PEDIATRICS · doi:10.1542/peds.2012-0498 · Cited by 207
Cardiopulmonary Resuscitation in Infants and Children With Cardiac Disease
Marino, B. S., Tabbutt, S., MacLaren, G., Hazinski, M. F., Adatia, I., Atkins, D. L., Checchia, P. A., DeCaen, A., Fink, E. L., Hoffman, G. M., et al. (2018) · Circulation · doi:10.1161/cir.0000000000000524 · Cited by 206
The energetic brain—A review from students to students
Bordone, M. P., Salman, M. M., Titus, H. E., Amini, E., Andersen, J. V., Chakraborti, B., Diuba, A. V., Dubouskaya, T. G., Ehrke, E., Espindola de Freitas, A., et al. (2019) · Journal of Neurochemistry · doi:10.1111/jnc.14829 · Cited by 205
Therapeutic Hypothermia for Neonatal Hypoxic–Ischemic Encephalopathy – Where to from Here?
Davidson, J. O., Wassink, G., van den Heuij, L. G., Bennet, L., & Gunn, A. J. (2015) · Frontiers in Neurology · doi:10.3389/fneur.2015.00198 · Cited by 203
Multicenter cohort study of out-of-hospital pediatric cardiac arrest*
Moler, F. W., Donaldson, A. E., Meert, K. L., Brilli, R. J., Nadkarni, V., Shaffner, D. H., Schleien, C. L., Clark, R. S. B., Dalton, H. J., Statler, K. D., et al. (2010) · Critical Care Medicine · doi:10.1097/ccm.0b013e3181fa3c17 · Cited by 203
The biological basis of injury and neuroprotection in the fetal and neonatal brain
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Human Neural Stem Cell Grafts Modify Microglial Response and Enhance Axonal Sprouting in Neonatal Hypoxic–Ischemic Brain Injury
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Authors: Shankaran, S., Laptook, A. R., Ehrenkranz, R. A., Tyson, J. E., McDonald, S. A., Donovan, E. F., Fanaroff, A. A., Poole, W. K., Wright, L. L., Higgins, R. D., Finer, N. N., Carlo, W. A., Duara, S., Oh, W., Cotten, C. M., Stevenson, D. K., Stoll, B. J., Lemons, J. A., Guillet, R., & Jobe, A. H.
Affiliations: Wayne State University (US)
Women & Infants Hospital of Rhode Island (US)
Yale University (US)
RTI International (US)
University of Cincinnati (US)
Rainbow Babies & Children's Hospital (US)
National Institutes of Health (US)
University of California San Diego (US)
University of Alabama at Birmingham (US)
University of Miami (US)
Duke Medical Center (US)
Stanford University (US)
Emory University (US)
Indiana University School of Medicine (US)
University of Rochester (US)
ORCID: Shankaran, Seetha
Laptook, Abbot R.
McDonald, Scott A.
Higgins, Rosemary D.
Carlo, Waldemar A.
Duara, Shahnaz
Cotten, C. Michael
Stevenson, David K.
Stoll, Barbara J.
Guillet, Ronnie
Jobe, Alan H.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2005-10-13
Volume: 353
Issue: 15
Pages: 1574-1584
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmcps050929
OpenAlex: W2164127547
Cited by: 2,862
References: 36
Citations by year: 2026: 95 · 2025: 152 · 2024: 157 · 2023: 121 · 2022: 118 · 2021: 155 · 2020: 123 · 2019: 129 · 2018: 152 · 2017: 152 · 2016: 143 · 2015: 170 · 2014: 131 · 2013: 141 · 2012: 166
FWCI: 89.20
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
UWA Profiles and Research Repository (UWA) (submittedVersion)
Funders: National Center for Research Resources (5-M01-RR-00044, M01RR008084, M01-RR00039, M01RR000125, M01-RR 00750, M01 RR-00125, M01 RR 0039-43, M01RR000750, M-01 RR 00070, M01RR000044, M01RR000070, M01RR000039, M01-RR-08084)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10HD040498, (U10 HD27871, U10 HD 27853, U10HD027880, U10 HD27880, U10 HD 40461, U10HD40521, U10HD21385, U10HD 21397, U10HD40498, U10HD27851, U10 HD34216, U10HD40492, U01HD36790, U10‐HD‐27904, U10HD021397, U10HD027904, U10HD027856, U10HD040689, U10HD027871, U10-HD21373, U10HD027853, U10HD040492, U10HD034216, U10HD021373, U10HD021385, U10HD40689, U10 HD27856, U10HD040521, U01HD036790, U10HD027851, U10HD040461)
Topics: Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Neonatal and fetal brain pathology
Health Sciences › Medicine › Critical Care and Intensive Care Medicine › Thermal Regulation in Medicine
Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Infant Development and Preterm Care
Keywords: whole-body hypothermia, hypoxic-ischemic encephalopathy, neonates, neuroprotection, cerebral palsy, neurodevelopmental outcomes, perinatal asphyxia, acidosis, term infants, mortality, disability
MeSH terms: Acidosis, Asphyxia Neonatorum, Blindness, Cerebral Palsy, Developmental Disabilities, Female, Follow-Up Studies, Humans, Hypothermia, Induced, Infant, Newborn, Obstetric Labor Complications, Male, Pregnancy, Pregnancy Complications, Hypoxia-Ischemia, Brain, Hearing Loss

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Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy

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