Neonatal ECMO Study of Temperature (NEST) - a randomised controlled trial

BMC Pediatrics

Volumn 10, Issue , 2010, Pages

  Field, David J ^a   Firmin, Richard ^b   Azzopardi, Denis V ^c   Cowan, Frances ^d   Juszczak, Edmund ^e   Brocklehurst, Peter ^e  

^a UNIVERSITY OF LEICESTER   (United Kingdom)

^b GLENFIELD HOSPITAL   (United Kingdom)

^c IMPERIAL COLLEGE LONDON   (United Kingdom)

^d HAMMERSMITH HOSPITAL   (United Kingdom)

^e UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BRAIN HYPOXIA; BRAIN ISCHEMIA; CLINICAL TRIAL; COGNITION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COOLING; EXTRACORPOREAL OXYGENATION; FOLLOW UP; HEALTH STATUS; HUMAN; INFANT; INFORMED CONSENT; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NEWBORN; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SURVIVAL; TEMPERATURE; UNITED KINGDOM; BODY TEMPERATURE; COMPARATIVE STUDY; DEVELOPMENTAL DISORDER; FEMALE; HEART FAILURE; INDUCED HYPOTHERMIA; INTELLIGENCE; MALE; METHODOLOGY; PATHOPHYSIOLOGY; RESPIRATORY FAILURE; TIME; TREATMENT OUTCOME;

BODY TEMPERATURE; DEVELOPMENTAL DISABILITIES; EXTRACORPOREAL MEMBRANE OXYGENATION; FEMALE; FOLLOW-UP STUDIES; GREAT BRITAIN; HEART FAILURE; HUMANS; HYPOTHERMIA, INDUCED; INFANT, NEWBORN; INTELLIGENCE; MALE; RESPIRATORY INSUFFICIENCY; TIME FACTORS; TREATMENT OUTCOME;

EID: 77950934127     PISSN: None     EISSN: 14712431     Source Type: Journal    
DOI: 10.1186/1471-2431-10-24     Document Type: Article

References (43)

1. UK Collaborative ECMO Trial Group UK collaborative randomised trial of neonatal extracorporeal membrane oxygenation. Lancet 1996, 348:75-82. 10.1016/S0140-6736(96)04100-1, 8676720, UK Collaborative ECMO Trial Group.
2. Bennett CC, Johnson A, Field DJ, Elbourne D. UK collaborative randomised trial of neonatal extracorporeal membrane oxygenation: follow-up to age 4 years. Lancet 2001, 357:1094-6. 10.1016/S0140-6736(00)04310-5, 11297963.
3. Horan M, Ichiba S, Firmin RK, Killer HM, Edwards D, Azzopardi D, Hodge R, Kotecha S, Field D. A pilot investigation of mild hypothermia in neonates receiving extracorporeal membrane oxygenation (ECMO). J Pediatr 2004, 144:301-8. 10.1016/j.jpeds.2003.11.034, 15001932.
4. Wu YW, Miller SP, Chin K, Collins AE, Lomeli SC, Chuang NA, Barkovich AJ, Ferriero DM. Multiple risk factors in neonatal sinovenous thrombosis. Neurology 2002, 59:438-40.
5. Van Heijst A, Liem D, Hopman J, Staak F, Sengers R. Oxygenation and hemodynamics in left and right cerebral hemispheres during induction of veno-arterial extracorporeal membrane oxygenation. J Pediatr 2004, 144:223-8. 10.1016/j.jpeds.2003.11.006, 14760266.
6. Roelants-van Rijn AM, Grond J, de Vries LS, Groenendaal F. Cerebral proton magnetic resonance spectroscopy of neonates after extracorporeal membrane oxygenation. Acta Paediatr 2001, 90:1288-91. 10.1080/080352501317130344, 11808901.
7. Lorch SA, D'Agostino JA, Zimmerman R, Bernbaum J. "Benign" extra-axial fluid in survivors of neonatal intensive care. Arch Pediatr Adolesc Med 2004, 158:178-82. 10.1001/archpedi.158.2.178, 14757610.
8. Lazar EL, Abramson SJ, Weinstein S, Stolar CJ. Neuroimaging of brain injury in neonates treated with extracorporeal membrane oxygenation: lessons learned from serial examinations. J Pediatr Surg 1994, 29:186-90. discussion 90-1., 10.1016/0022-3468(94)90315-8, 8176589.
9. Lago P, Rebsamen S, Clancy RR, Pinto-Martin J, Kessler A, Zimmerman R, Schmelling D, Bernbaum J, Gerdes M, D'Agostino JA, et al. MRI, MRA, and neurodevelopmental outcome following neonatal ECMO. Pediatr Neurol 1995, 12:294-304. 10.1016/0887-8994(95)00047-J, 7546003.
10. Mercuri E, Ricci D, Cowan FM, Lessing D, Frisone MF, Haataja L, Counsell SJ, Dubowitz LM, Rutherford MA. Head growth in infants with hypoxic-ischemic encephalopathy: correlation with neonatal magnetic resonance imaging. Pediatrics 2000, 106:235-43. 10.1542/peds.106.2.235, 10920145.
11. Cowan F, Dubowitz L, Mercuri E, Counsell S, Barnett A, Rutherford MA. Cognitive but not major motor deficits following perinatal asphyxia and early encephalopathy: a consequence of white matter injury. Early Hum Dev 2003, 73:113-4.
12. Cowan F. Outcome after intrapartum asphyxia in term infants. Semin Neonatol 2000, 5:127-40. 10.1053/siny.2000.0011, 10859707.
13. Mercuri E, Barnett A, Rutherford M, Guzzetta A, Haataja L, Cioni G, Cowan F, Dubowitz L. Neonatal cerebral infarction and neuromotor outcome at school age. Pediatrics 2004, 113:95-100. 10.1542/peds.113.1.95, 14702455.
14. Mercuri E, Cowan F. Cerebral infarction in the newborn infant: review of the literature and personal experience. Eur J Paediatr Neurol 1999, 3:255-63. 10.1016/S1090-3798(99)90980-7, 10595670.
15. Thoresen M, Penrice J, Lorek A, Cady EB, Wylezinska M, Kirkbride V, Cooper CE, Brown CG, Edwards AD, Wyatt JS, et al. Mild hypothermia after severe transient hypoxia-ischemia ameliorates delayed cerebral energy failure in the newborn piglet. Pediatr Res 1995, 37:667-70. 10.1203/00006450-199505000-00019, 7603788.
16. Taylor DL, Mehmet H, Cady EB, Edwards AD. Improved neuroprotection with hypothermia delayed by 6 hours following cerebral hypoxia-ischemia in the 14-day-old rat. Pediatr Res 2002, 51:13-9. 10.1203/00006450-200201000-00005, 11756634.
17. Sirimanne ES, Blumberg RM, Bossano D, Gunning M, Edwards AD, Gluckman PD, Williams CE. The effect of prolonged modification of cerebral temperature on outcome after hypoxic-ischemic brain injury in the infant rat. Pediatr Res 1996, 39:591-7. 10.1203/00006450-199604000-00005, 8848330.
18. Gunn AJ, Gunn TR, de Haan HH, Williams CE, Gluckman PD. Dramatic neuronal rescue with prolonged selective head cooling after ischemia in fetal lambs. J Clin Invest 1997, 99:248-56. 10.1172/JCI119153, 507792, 9005993.
19. Colbourne F, Corbett D. Delayed postischemic hypothermia: a six month survival study using behavioral and histological assessments of neuroprotection. J Neurosci 1995, 15:7250-60.
20. The Hypothermia after Cardiac Arrest Study Group Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med 2002, 346:549-56. 10.1056/NEJMoa012689, 11856793, The Hypothermia after Cardiac Arrest Study Group.
21. Thoresen M, Whitelaw A. Cardiovascular changes during mild therapeutic hypothermia and rewarming in infants with hypoxic-ischemic encephalopathy. Pediatrics 2000, 106:92-9. 10.1542/peds.106.1.92, 10878155.
22. Gunn AJ, Gluckman PD, Gunn TR. Selective head cooling in newborn infants after perinatal asphyxia: a safety study. Pediatrics 1998, 102:885-92. 10.1542/peds.102.4.885, 9755260.
23. Azzopardi D, Robertson NJ, Cowan FM, Rutherford MA, Rampling M, Edwards AD. Pilot study of treatment with whole body hypothermia for neonatal encephalopathy. Pediatrics 2000, 106:684-94. 10.1542/peds.106.4.684, 11015509.
24. Gluckman PD, Wyatt JS, Azzopardi D, Ballard R, Edwards AD, Ferriero DM, Polin RA, Robertson CM, Thoresen M, Whitelaw A, Gunn AJ. Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomised trial. Lancet 2005, 365:663-70.
25. Shankaran S, Laptook AR, Ehrenkranz RA, Tyson JE, McDonald SA, Donovan EF, Fanaroff AA, Poole WK, Wright LL, Higgins RD, Finer NN, Carlo WA, Duara S, Oh W, Cotten CM, Stevenson DK, Stoll BJ, Lemons JA, Guillet R, Jobe AH, . National Institute of Child Health and Human Development Neonatal Research Network Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy. N Engl J Med 2005, 353:1574-84. 10.1056/NEJMcps050929, 16221780, National Institute of Child Health and Human Development Neonatal Research Network.
26. Rutherford MA, Azzopardi D, Whitelaw A, Cowan F, Renowden S, Edwards AD, Thoresen M. Mild hypothermia and the distribution of cerebral lesions in neonates with hypoxic-ischemic encephalopathy. Pediatrics 2005, 116:1001-6. 10.1542/peds.2005-0328, 16199715.
27. Hanrahan JD, Cox IJ, Edwards AD, Cowan FM, Sargentoni J, Bell JD, Bryant DJ, Rutherford MA, Azzopardi D. Persistent increases in cerebral lactate concentration after birth asphyxia. Pediatr Res 1998, 44:304-11. 10.1203/00006450-199809000-00007, 9727705.
28. Shimokawa M, Kitaguchi K, Kawaguchi M, Sakamoto T, Kakimoto M, Furuya H. The influence of induced hypothermia for hemostatic function on temperature-adjusted measurements in rabbits. Anesth Analg 2003, 96:1209-13. table of contents., 10.1213/01.ANE.0000050767.86196.AF, 12651686.
29. Menasche P, Peynet J, Haeffner-Cavaillon N, Carreno MP, de Chaumaray T, Dillisse V, Faris B, Piwnica A, Bloch G, Tedgui A. Influence of temperature on neutrophil trafficking during clinical cardiopulmonary bypass. Circulation 1995, 92:II334-40.
30. Boldt J, Knothe C, Welters I, Dapper FL, Hempelmann G. Normothermic versus hypothermic cardiopulmonary bypass: do changes in coagulation differ?. Ann Thorac Surg 1996, 62:130-5. 10.1016/0003-4975(96)00239-1, 8678631.
31. Ichiba S, Killer HM, Firmin RK, Kotecha S, Edwards AD, Field D. Pilot investigation of hypothermia in neonates receiving extracorporeal membrane oxygenation. Arch Dis Child Fetal Neonatal Ed 2003, 88:F128-33. 10.1136/fn.88.2.F128, 1721509, 12598502.
32. Davis PJ, Firmin RK, Manktelow B, Goldman AP, Davis CF, Smith JH, Cassidy JV, Shekerdemian LS. Long-term outcome following extracorporeal membrane oxygenation for congenital diaphragmatic hernia: the UK experience. J Pediatr 2004, 144:309-15. 10.1016/j.jpeds.2003.11.031, 15001933.
33. Bayley N. Manual for the Bayley Scales of Infant and Toddler Development 2006, San Antonio, Texas: Harcourt Assessment, 3.
34. Haataja L, Mercuri E, Regev R, Cowan F, Rutherford M, Dubowitz V, Dubowitz L. Optimality score for the neurologic examination of the infant at 12 and 18 months of age. J Pediatr 1999, 135:153-61. 10.1016/S0022-3476(99)70016-8, 10431108.
35. Haataja L, Mercuri E, Guzzetta A, Rutherford M, Counsell S, Flavia Frisone M, Cioni G, Cowan F, Dubowitz L. Neurologic examination in infants with hypoxic-ischemic encephalopathy at age 9 to 14 months: use of optimality scores and correlation with magnetic resonance imaging findings. J Pediatr 2001, 138:332-7. 10.1067/mpd.2001.111325, 11241038.
36. Palisano RJ, Cameron D, Rosenbaum PL, Walter SD, Russell D. Stability of the gross motor function classification system. Dev Med Child Neurol 2006, 48:424-8. 10.1017/S0012162206000934, 16700931.
37. Saudino K, Dale P, Oliver B, Petrill S, Richardson V, Rutter M, et al. The validity of a parent-based assessment of the cognitive abilities of 2-year olds. Br J Dev Psychol 1998, 16:349-63.
38. Johnson S, Wolke D, Marlow N. Developmental assessment of preterm infants at 2 years: validity of parent reports. Dev Med Child Neurol 2008, 50:58-62. 10.1111/j.1469-8749.2007.02010.x, 18173632.
39. Johnson S, Marlow N, Wolke D, Davidson L, Marston L, O'Hare A, Peacock J, Schutle J. Validation of a parent report measure of cognitive development in very preterm infants. Dev Med Child Neurol 2004, 46:389-97.
40. Lee CL, Bates JE. Mother-child interaction at age two years and perceived difficult temperament. Child Dev 1985, 56:1314-25. 10.2307/1130246, 4053745.
41. Briggs-Gowan MJ, Carter AS, Irwin JR, Wachtel K, Cicchetti DV. The Brief Infant-Toddler Social and Emotional Assessment: screening for social-emotional problems and delays in competence. J Pediatr Psychol 2004, 29:143-55. 10.1093/jpepsy/jsh017, 15096535.
42. Wood NS, Marlow N, Costeloe K, Gibson AT, Wilkinson AR. Neurologic and developmental disability after extremely preterm birth. EPICure Study Group. N Engl J Med 2000, 343:378-84. 10.1056/NEJM200008103430601, 10933736.
43. Hansen-Pupp I, Hallin AL, Hellstrom-Westas L, Cilio C, Berg AC, Stjernqvist K, Fellman V, Ley D. Inflammation at birth is associated with subnormal development in very preterm infants. Pediatr Res 2008, 64:183-8. 10.1203/PDR.0b013e318176144d, 18391842.