Antenatal allopurinol for reduction of birth asphyxia induced brain damage (ALLO-Trial); a randomized double blind placebo controlled multicenter study

BMC Pregnancy and Childbirth

Volumn 10, Issue , 2010, Pages

  Kaandorp, Joepe J ^a   Benders, Manon J N L ^a   Rademaker, Carin M A ^a   Torrance, Helen L ^a   Oudijk, Martijn A ^b   de Haan, Timo R ^b   Bloemenkamp, Kitty W M ^c   Rijken, Monique ^c   van Pampus, Maria G ^d   Bos, Arie F ^d   Porath, Martina M ^e   Oetomo, Sidarto B ^e   Willekes, Christine ^f   Gavilanes, AW Danilo ^f   Wouters, Maurice G A J ^g   van Elburg, Ruurd M ^g   Huisjes, Anjoke J M ^h   Bakker, Saskia C M J E R ^h   van Meir, Claudia A ⁱ   von Lindern, Jeannette ⁱ   Boon, Janine ^j   de Boer, Inge P ^j   Rijnders, Robbert J P ^k   Jacobs, Corrie J W F M ^k   Uiterwaal, Cuno S P M ^a   Mol, Ben Willem J ^b   Visser, Gerard H A ^a   van Bel, Frank ^a   Derks, Jan B ^a   more..

^a UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^b ACADEMIC MEDICAL CENTER   (Netherlands)

^c LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^d UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^e MÁXIMA MEDICAL CENTER   (Netherlands)

^f MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^g VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^h GELRE HOSPITALS   (Netherlands)

ⁱ GROENE HART HOSPITAL   (Netherlands)

^j DEPARTMENT OF SURGERY   (Netherlands)

^k JEROEN BOSCH HOSPITAL   (Netherlands)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALLOPURINOL; HYPOXANTHINE; IRON; ISOPROSTANE; PLACEBO; PROTEIN S100B; BIOLOGICAL MARKER; ENOLASE; NERVE GROWTH FACTOR; PROTEIN S 100; S 100 CALCIUM BINDING PROTEIN BETA SUBUNIT; S-100 CALCIUM-BINDING PROTEIN BETA SUBUNIT; SCAVENGER; XANTHINE OXIDASE;

ARTICLE; BLOOD LEVEL; BLOOD PH; BRAIN DAMAGE; BRAIN DISEASE; BRAIN HYPOXIA; BRAIN ISCHEMIA; CLINICAL TRIAL; DATA ANALYSIS; DOUBLE BLIND PROCEDURE; FEMALE; FETUS; FETUS BLOOD SAMPLING; FETUS DISTRESS; FETUS HEART RATE; FETUS HYPOXIA; HUMAN; MULTICENTER STUDY; NERVOUS SYSTEM FUNCTION; NEWBORN MORBIDITY; NEWBORN MORTALITY; OUTCOME ASSESSMENT; OXIDATIVE STRESS; PERINATAL ASPHYXIA; PREGNANT WOMAN; PRENATAL CARE; PRENATAL PERIOD; RANDOMIZED CONTROLLED TRIAL; ST SEGMENT; UMBILICAL CORD BLOOD; BLOOD; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG ANTAGONISM; METHODOLOGY; MULTIVARIATE ANALYSIS; NETHERLANDS; NEWBORN; NEWBORN HYPOXIA; PILOT STUDY; PREGNANCY; PROSPECTIVE STUDY; REGRESSION ANALYSIS;

ALLOPURINOL; ASPHYXIA NEONATORUM; BIOLOGICAL MARKERS; DOUBLE-BLIND METHOD; FEMALE; FETAL HYPOXIA; FREE RADICAL SCAVENGERS; HUMANS; HYPOXIA-ISCHEMIA, BRAIN; INFANT, NEWBORN; MULTIVARIATE ANALYSIS; NERVE GROWTH FACTORS; NETHERLANDS; PHOSPHOPYRUVATE HYDRATASE; PILOT PROJECTS; PREGNANCY; PRENATAL CARE; PROSPECTIVE STUDIES; REGRESSION ANALYSIS; S100 PROTEINS; XANTHINE OXIDASE;

EID: 77949461630     PISSN: None     EISSN: 14712393     Source Type: Journal    
DOI: 10.1186/1471-2393-10-8     Document Type: Article

References (25)

1. Fellman V, Raivio KO. Reperfusion injury as the mechanism of brain damage after perinatal asphyxia. Pediatr Res 1997, 41:599-606. 10.1203/00006450-199705000-00001, 9128279.
2. Rosenberg AA, Murdaugh E, White CW. The role of oxygen free radicals in postasphyxia cerebral hypoperfusion in newborn lambs. Pediatr Res 1989, 26:215-219. 10.1203/00006450-198909000-00012, 2587123.
3. Warner DS, Sheng H, Batinic-Haberle I. Oxidants, antioxidants and the ischemic brain. J Exp Biol 2004, 207:3221-3231. 10.1242/jeb.01022, 15299043.
4. Palmer C, Vannucci RC, Towfighi J. Reduction of perinatal hypoxic-ischemic brain damage with allopurinol. Pediatr Res 1990, 27:332-336. 10.1203/00006450-199004000-00003, 2342827.
5. Whitelaw A. Systematic review of therapy after hypoxic-ischaemic brain injury in the perinatal period. Semin Neonatol 2000, 5:33-40. 10.1053/siny.1999.0113, 10802748.
6. Peeters-Scholte C, Braun K, Koster J, Kops N, Blomgren K, Buonocore G, van Buul-Offers S, Hagberg H, Nicolay K, van Bel F, Groenendaal F. Effects of allopurinol and deferoxamine on reperfusion injury of the brain in newborn piglets after neonatal hypoxia-ischemia. Pediatr Res 2003, 54:516-522. 10.1203/01.PDR.0000081297.53793.C6, 12815112.
7. Van Bel F, Shadid M, Moison RM, Dorrepaal CA, Fontijn J, Monteiro L, van de Bor, Berger HM. Effect of allopurinol on postasphyxial free radical formation, cerebral hemodynamics, and electrical brain activity. Pediatrics 1998, 101:185-193. 10.1542/peds.101.2.185, 9445490.
8. Gunes T, Ozturk MA, Koklu E, Kose K, Gunes I. Effect of allopurinol supplementation on nitric oxide levels in asphyxiated newborns. Pediatr Neurol 2007, 36:17-24. 10.1016/j.pediatrneurol.2006.08.005, 17162192.
9. Benders MJ, Bos AF, Rademaker CM, Rijken M, Torrance HL, Groenendaal F, van Bel F. Early postnatal allopurinol does not improve short term outcome after severe birth asphyxia. Arch Dis Child Fetal Neonatal Ed 2006, 91:163-165.
10. 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, 365:663-670.
11. Boda D, Németh P, Kiss P, Orvos H. Treatment of mothers with allopurinol to produce therapeutic blood levels in newborns. Prenat Neonat Med 1999, 4:130-134.
12. van Dijk AJ, Parvizi N, Taverne MA, Fink-Gremmels J. Placental transfer and pharmacokinetics of allopurinol in late pregnant sows and their fetuses. J Vet Pharmacol Ther 2008, 31:489-495. 10.1111/j.1365-2885.2008.00976.x, 19000269.
13. Derks JB, Oudijk MA, Rosén KG, Thakor AS, Visser GHA, van Bel F, Giussani DA. Allopurinol maintains umbilical blood flow following repeated episodes of ischaemia-reperfusion in fetal sheep during late gestation [abstract]. J Soc Gynecol Invest 2006, 13:s35.
14. Masaoka N, Nakajima Y, Hayakawa Y, Ohgame S, Hamano S, Nagaishi M, Yamamoto T. Transplacental effects of allopurinol on suppression of oxygen free radical production in chronically instrumented fetal lamb brains during intermittent umbilical cord occlusion. J Matern Fetal Neonatal Med 2005, 18:1-7. 10.1080/14767050500127716, 16105785.
15. Torrance HL, Benders MJ, Derks JB, Rademaker CM, Bos AF, Berg P, Longini M, Buonocore G, Venegas M, Baquero H, Visser GH, Van Bel F. Maternal allopurinol during fetal hypoxia lowers cord blood levels of the brain injury marker S-100B. Pediatrics 2009, 124:350-357. 10.1542/peds.2008-2228, 19564319.
16. Torrance H, Derks JB, Oudijk MA, Thakor AS, Cindrova-Davies T, van Bel F, Visser GHA, Burton GJ, Giussani DA. Maternal treatment with allopurinol diminishes fetal cardiac oxidative stress following repeated episodes of ischaemia-reperfusion in sheep. Proceedings of the 34th annual meeting of the Fetal and Neonatal Physiological Society; 26-29 august 2007, Sendai, Japan 2007, 90.
17. Ferriero DM. Neonatal brain injury. N Engl J Med 2004, 351:1985-1995. 10.1056/NEJMra041996, 15525724.
18. Hagberg B, Hagberg G, Olow I. The changing panorama of cerebral palsy in Sweden. VI. Prevalence and origin during the birth year period 1983-1986. Acta Paediatr 1993, 82:387-393. 10.1111/j.1651-2227.1993.tb12704.x, 8318808.
19. van Handel M, Swaab H, de Vries LS, Jongmans MJ. Long-term cognitive and behavioral consequences of neonatal encephalopathy following perinatal asphyxia: a review. Eur J Pediatr 2007, 166:645-654. 10.1007/s00431-007-0437-8, 1914268, 17426984.
20. Summary of Product Characteristics Acepurin®. , http://db.cbg-meb.nl/Bijsluiters/h09974.pdf
21. Halevy S, Ghislain PD, Mockenhaupt M, Fagot JP, Bouwes Bavinck JN, Sidoroff A, Naldi L, Dunant A, Viboud C, Roujeau JC, . EuroSCAR Study Group Allopurinol is the most common cause of Stevens-Johnson syndrome and toxic epidermal necrolysis in Europe and Israel. J Am Acad Dermatol 2008, 58:25-32. 10.1016/j.jaad.2007.08.036, 17919772, EuroSCAR Study Group.
22. Chaudhari T, McGuire W. Allopurinol for preventing mortality and morbidity in newborn infants with suspected hypoxic-ischaemic encephalopathy. Cochrane Database Syst Rev 2008, 16(2):CD006817.
23. van Kesteren C, Benders MJ, Groenendaal F, van Bel F, Ververs FF, Rademaker CM. Population pharmacokinetics of allopurinol in full-term neonates with perinatal asphyxia. Ther Drug Monit 2006, 28:339-344. 10.1097/01.ftd.0000211808.74192.86, 16778717.
24. Sarnat HB, Sarnat MS. Neonatal encephalopathy following fetal distress. A clinical and electroencephalographic study. Arch Neurol 1976, 33:696-705.
25. Thompson CM, Puterman AS, Linley LL, Hann FM, Elst CW, Molteno CD, Malan AF. The value of a scoring system for hypoxic ischaemic encephalopathy in predicting neurodevelopmental outcome. Acta Paediatr 1997, 86:757-761. 10.1111/j.1651-2227.1997.tb08581.x, 9240886.