The INIS Study. International Neonatal Immunotherapy Study: Non-specific intravenous immunoglobulin therapy for suspected or proven neonatal sepsis: An international, placebo controlled, multicentre randomised trial

BMC Pregnancy and Childbirth

Volumn 8, Issue , 2008, Pages

  Brocklehurst, Peter ^a   Brearley, Sally ^b   Haque, Khalid ^c   Leslie, Andy ^d   Salt, Alison ^e   Stenson, Ben ^f   Stephenson, Jim ^c   Tarnow Mordi, William ^g  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b St Helier Hospital ^*  (United Kingdom)

^c ST HELIER HOSPITAL   (United Kingdom)

^d NOTTINGHAM CITY HOSPITAL   (United Kingdom)

^e MOORFIELDS EYE HOSPITAL   (United Kingdom)

^f ROYAL INFIRMARY OF EDINBURGH   (United Kingdom)

^g WESTMEAD HOSPITAL   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; GRANULOCYTE COLONY STIMULATING FACTOR; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; IMMUNOGLOBULIN; PENTOXIFYLLINE; PLACEBO; RECOMBINANT CYTOKINE;

ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEVELOPMENTAL DISORDER; DISABILITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; ERYTHROCYTE; FEMALE; FOLLOW UP; GESTATIONAL AGE; HEMOLYSIS; HOSPITAL DISCHARGE; HUMAN; INCIDENCE; INFANT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NERVOUS SYSTEM DEVELOPMENT; NEUTROPENIA; NEWBORN MORTALITY; NEWBORN SEPSIS; PRION DISEASE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SEPTIC SHOCK; TREATMENT DURATION; VIRUS TRANSMISSION;

EID: 62549166257     PISSN: None     EISSN: 14712393     Source Type: Journal    
DOI: 10.1186/1471-2393-8-52     Document Type: Article

References (64)

1. Grether JK Nelson KB Maternal infection and cerebral palsy in infants of normal birth weight JAMA 1997, 278(3):207-11 10.1001/jama.278.3.207 9218666
2. Murphy DJ Sellers S MacKenzie IZ Yudkin PL Johnson AM Case-control study of antenatal and intrapartum risk factors for cerebral palsy in very preterm singleton babies Lancet 1995, 346(8988):1449-54 10.1016/ S0140-6736(95)92471-X 7490990
3. Parliamentary Select Committee House of Lords inquiry into antimicrobial resistance Commun Dis Rep CDR Wkly 1998, 8(17):147-150
4. Levy SB The challenge of antibiotic resistance Sci Am 1998, 278(3):46-53 9487702
5. Isaacs D Barfield CP Grimwood K McPhee AJ Minutillo C Tudehope DI Systemic bacterial and fungal infections in infants in Australian neonatal units. Australian Study Group for Neonatal Infections Med J Aust 1995, 162(4):198-201 7877542
6. UK Neonatal Staffing study group Patient volume, staffing and workload in relation to risk-adjusted outcomes in a stratified sample of UK neonatal intensive care units: A prospective evaluation Lancet 2002, 359:99-107 10.1016/S0140-6736(02)07366-X 11809250
7. Fanaroff AA Korones SB Wright LL Verter J Poland RL Bauer CR Tyson JE Philips JB Edwards W Lucey JF Catz CS Shankaran S Oh W Incidence, presenting features, risk factors and significance of late onset septicemia in very low birth weight infants. The National Institute of Child Health and Human Development Neonatal Research Network Pediatr Infect Dis J 1998, 17(7):593-8 10.1097/00006454-199807000-00004 9686724
8. Schelonka RL Chai MK Yoder BA Hensley D Brockett RM Ascher DP Volume of blood required to detect common neonatal pathogens J Pediatr 1996, 129(2):275-8 10.1016/S0022-3476(96)70254-8 8765627
9. Barton L Hodgman JE Pavlova Z Causes of death in the extremely low birth weight infant Pediatrics 1999, 103(2):446-51 10.1542/peds.103.2.446 9925839
10. Nelson KB Dambrosia JM Grether JK Phillips TM Neonatal cytokines and coagulation factors in children with cerebral palsy Ann Neurol 1998, 44(4):665-75 10.1002/ana.410440413 9778266
11. Dammann O Leviton A Infection remote from the brain, neonatal white matter damage, and cerebral palsy in the preterm infant Semin Pediatr Neurol 1998, 5(3):190-201 10.1016/S1071-9091(98)80034-X 9777677
12. Dammann O Leviton A Brain damage in preterm newborns: Might enhancement of developmentally regulated endogenous protection open a door for prevention? Pediatrics 1999, 104(3):541-50 10.1542/peds.104.3.541 10469783
13. Baley JE Neonatal sepsis: The potential for immunotherapy Clin Perinatol 1988, 15(4):755-71 3061698
14. Fujiwara T Taniuchi S Hattori K Kobayashi T Kinoshita Y Kobayashi Y Effect of immunoglobulin therapy on phagocytosis by polymorphonuclear leucocytes in whole blood of neonates Clin Exp Immunol 1997, 107(3):435-9 1904605 9067513 10.1046/j.1365-2249.1997.d01-957.x
15. Christensen RD Brown MS Hall DC Lassiter HA Hill HR Effect on neutrophil kinetics and serum opsonic capacity of intravenous administration of immune globulin to neonates with clinical signs of early-onset sepsis J Pediatr 1991, 118(4 Pt 1):606-14 1901083
16. Harper TE Christensen RD Rothstein G Hill HR Effect of intravenous immunoglobulin G on neutrophil kinetics during experimental group B streptococcal infection in neonatal rats Rev Infect Dis 1986, 8(Suppl 4):S401-8 3092307
17. Masouye P Gunning K Pittet JF Suter PM Morel DR Xanthine derivative HWA 138 attenuates hemodynamic and oxygen uptake dysfunction secondary to severe endotoxin shock in sheep Circ Shock 1992, 36(2):113-19 1582002
18. Lundblad R Ekstrom P Giercksky KE Pentoxifylline improves survival and reduces tumor necrosis factor, interleukin-6, and endothelin-1 in fulminant intra-abdominal sepsis in rats Shock 1995, 3(3):210-15 10.1097/ 00024382-199503000-00009 7773801
19. Zeni F Pain P Vindimian M Gay JP Gery P Bertrand M Page Y Page D Bertrand JC Effects of pentoxifylline on circulating cytokine concentrations and hemodynamics in patients with septic shock: Results from a double-blind, randomized, placebo-controlled study Crit Care Med 1996, 24(2):207-14 10.1097/00003246-199602000-00005 8605790
20. Staudinger T Presterl E Graninger W Locker GJ Knapp S Laczika K Klappacher G Stoiser B Wagner A Tesinsky P Kordova H Frass M Influence of pentoxifylline on cytokine levels and inflammatory parameters in septic shock Intensive Care Med 1996, 22(9):888-93 10.1007/BF02044112 8905422
21. Lauterbach R Zembala M Pentoxifylline reduces plasma tumour necrosis factor-alpha concentration in premature infants with sepsis Eur J Pediatr 1996, 155(5):404-9 10.1007/BF01955273 8741040
22. Lauterbach R Pawlik D Kowalczyk D Ksycinski W Helwich E Zembala M Effect of the immunomodulating agent, pentoxifylline, in the treatment of sepsis in prematurely delivered infants: A placebo-controlled, double-blind trial Crit Care Med 1999, 27(4):807-14 10.1097/ 00003246-199904000-00042 10321674
23. Perez EM Weisman LE Novel approaches to the prevention and therapy of neonatal bacterial sepsis Clin Perinatol 1997, 24(1):213-29 9099511
24. Gillan ER Christensen RD Suen Y Ellis R Ven van de C Cairo MS A randomized, placebo-controlled trial of recombinant human granulocyte colony-stimulating factor administration in newborn infants with presumed sepsis: Significant induction of peripheral and bone marrow neutrophilia Blood 1994, 84(5):1427-33 7520770
25. Drossou-Agakidou V Kanakoudi-Tsakalidou F Sarafidis K Taparkou A Tzimouli V Tsandali H Kremenopoulos G Administration of recombinant human granulocyte colony-stimulating factor to septic neonates induces neutrophilia and enhances the neutrophil respiratory burst and beta2 integrin expression. Results of a randomized controlled trial Eur J Pediatr 1998, 157(7):583-8 10.1007/s004310050884 9686822
26. Schibler KR Osborne KA Leung LY Le TV Baker SI Thompson DD A randomized, placebo-controlled trial of granulocyte colony-stimulating factor administration to newborn infants with neutropenia and clinical signs of early-onset sepsis Pediatrics 1998, 102(1 Pt 1):6-13 10.1542/ peds.102.1.6 9651406
27. Bedford Russell A Emmerson A Wilkinson N Holland B Sweet D Davies E UK multicentre prospective, randomised double blind placebo controlled trial of rhG-CSF (granulocyte colony-stimulating factor) in neonatal sepsis Proceedings of the Royal College of Paediatrics and Child Health Spring meeting 1999:G69
28. Carr R Modi N Doré J El-Rifai R Lindo Dl A randomized, controlled trial of prophylactic granulocyte-macrophage colony-stimulating factor in human newborns less than 32 weeks gestation Pediatrics 1999, 103:796-802 10.1542/peds.103.4.796 10103305
29. Cairo MS Agosti J Ellis R Laver JJ Puppala B deLemos R Givner L Nesin M Wheeler JG Seth T Ven van de C Fanaroff A A randomized, double-blind, placebo-controlled trial of prophylactic recombinant human granulocyte-macrophage colony-stimulating factor to reduce nosocomial infections in very low birth weight neonates J Pediatr 1999, 134(1):64-70 10.1016/S0022-3476(99)70373-2 9880451
30. Tarnow-Mordi W Healy M Distinguishing between "no evidence of effect" and "evidence of no effect" in randomised controlled trials and other comparisons Arch Dis Child 1999, 80(1):210-13 1717858 10325697
31. Cairo MS Worcester CC Rucker RW Hanten S Amlie RN Sender L Hicks DA Randomized trial of granulocyte transfusions versus intravenous immune globulin therapy for neonatal neutropenia and sepsis J Pediatr 1992, 120(2 Pt 1):281-5 1735830
32. Tollner U Pohlandt F Heinze F Henrichs I Treatment of septicaemia in the newborn infant: Choice of initial antimicrobial drugs and the role of exchange transfusion Acta Paediatr Scand 1977, 66(5):605-10 10.1111/ j.1651-2227.1977.tb07955.x 899779
33. Northern Neonatal Network Nursing Initiative Randomised trial of prophylactic early fresh-frozen plasma or gelatin or glucose in preterm babies: Outcome at 2 years. Northern Neonatal Nursing Initiative Trial Group Lancet 1996, 348(9022):229-32 10.1016/S0140-6736(95)12506-X 8684200
34. Ohlsson A Lacy JB Intravenous immunoglobulin for preventing infection in preterm and/or low-birthweight infants (Cochrane Review) The Cochrane Libary Oxford: Update Software 2003 2
35. Ohlsson A Lacy JB Intravenous immunoglobulin for suspected or subsequently proven infection in neonates (Cochrane Review) The Cochrane Libary Oxford: Update Software 2003 2
36. Samatha S Jalalu MP Hegde RK Vishwanath D Maiya PP Role of IgM enriched intravenous immunoglobulin as an adjuvant to antibiotics in neonatal sepsis Karnataka Pediatr J 1997, 11:1-6
37. Shenoi A Nagesh NK Maiya PP Bhat SR Rao SDS Multicentre randomized placebo controlled trial of therapy with intravenous immunoglobulin in decreasing mortality due to neonatal sepsis Indian Pediatr 1999, 36:1113-18 10745332
38. Mancila Ramirez J Gonzales R Castellanos C Garcia P Santos JI Immunoglobulina intravenosa en el tratamiento de septicemia neonatal Bol Med Hosp Infant Mex 1992, 49:4-11 1304766
39. Weisman LE Stoll B Kueser T Rubio TT Frank CG Heiman HS Subramanian KN Hankins CT Anthony BF Cruess DF Intravenous immune globulin therapy for early-onset sepsis in premature neonates J Pediatr 1992, 121(3):434-43 10.1016/S0022-3476(05)81802-5 1517923
40. Chen JY Intravenous immunoglobulin in the treatment of full-term and premature newborns with sepsis J Formosa Med Assoc 1996, 95:839-44
41. Haque KN Zaidi MH Bahakim H IgM-enriched intravenous immunoglobulin therapy in neonatal sepsis Am J Dis Child 1988, 142(12):1293-6 3195529
42. Erdem G Yurdakok M Tekinalp G Ersoy F The use of IgM-enriched intravenous immunoglobulin for the treatment of neonatal sepsis in preterm infants Turk J Pediatr 1993, 35(4):277-81 8160279
43. Sidiropoulos D Boehme U von Muralt G Morell A Barandun S Immunoglobulin supplementation in prevention or treatment of neonatal sepsis Pediatr Infect Dis 1986, 5(3 Suppl):S193-4 3714523
44. Jenson HB Pollock BH Meta-analyses of the effectiveness of intravenous immune globulin for prevention and treatment of neonatal sepsis Pediatrics 1997, 99(2):E2 10.1542/peds.99.2.e2 9099759
45. Alejandria MM Lansang MA Dans LF Mantaring JBV Intravenous immunoglobulin for treating sepsis and shock (Cochrane Review) The Cochrane Libary Oxford: Update Software 2003 2
46. Turner ML Ironside JW New-variant Creutzfeldt-Jakob disease: The risk of transmission by blood transfusion Blood Rev 1998, 12(4):255-68 10.1016/ S0268-960X(98)90007-8 9950096
47. Turner M The impact of new variant Creutzfeldt-Jakob disease on blood transfusion practice Br J Haematol 1999, 106:842-50 10.1046/ j.1365-2141.1999.01457.x 10519983
48. Foster PR Assessment of the potential of plasma fractionation processes to remove causative agents of transmissible spongiform encephalopathy Transfus Med 1999, 9(1):3-14 10.1046/j.1365-3148.1999.009001003.x 10216900
49. Osborn DA Lui K Pussell P Jana AK Desai AS Cole M T and Tk antigen activation in necrotising enterocolitis: Manifestations, severity of illness, and effectiveness of testing Arch Dis Child Fetal Neonatal Ed 1999, 80(3):F192-F197 1720919 10212080
50. Mollison P Engelfriet C Contreras M Blood Transfusion in Clinical Medicine Oxford: Blackwell 10 1997
51. Haque KN Remo C Bahakim H Comparison of two types of intravenous immunoglobulins in the treatment of neonatal sepsis Clin Exp Immunol 1995, 101(2):328-33 1553274 7648717
52. Haque K Management of neonatal sepsis in the UK: A national audit of practice J of Clinical Excellence 2000, 2:81-85
53. Taylor D Kenyon S Peto R Tarnow-Mordi W Preterm premature rupture of membranes Lancet 1996, 347(8995):204 10.1016/S0140-6736(96)90391-8 8544584
54. Taylor D Kenyon S Tarnow-Mordi W Infection and preterm labour [comment] Br J Obstet Gynaecol 1997, 104(12):1338-40 9422010
55. Tarnow-Mordi W Consent, information, and neonatal research [letter] Lancet 1999, 353(9163):1530-1 10.1016/S0140-6736(05)67227-3 10232351
56. Johnson A Follow up studies: A case for a standard minimum data set Arch Dis Child Fetal Neonatal Ed 1997, 76(1):F61-F63 1720604 9059192
57. Disability and perinatal care: Measurement of health status at two years A report of two working groups convened by the National Perinatal Epidemiology Unit and the former Oxford Regional Health Authority Oxford: NPEU 1994
58. Saudino KJ Dale PS Oliver B Petrill SA Richardson V Rutter M Simonoff E Stevenson J Plomin R The validity of parent-based assessment of the cognitive abilities of two-year olds British Journal of Development Psychology 1198, 16:349-63
59. Bayley N Bayley Scales of Infant Development San Antonio TX Psychological Corporation 2 1993
60. Peto R Pike M Armitage P Breslow N Cox D Howard S Mantel N McPherson K Peto J Smith DG Design and analysis of randomized clinical trials requiring prolonged observation of each patient. 1. Introduction and design Br J Cancer 1976, 34:585-612 795448
61. Tucker J Tarnow-Mordi W Gould C Parry G Marlow N UK neonatal intensive care services in 1996 Arch Dis Child Fetal Neonatal Ed 1999, 80(3):F233-F234 1720924 10212089
62. Peto R Baigent C Trials: The next 50 years. Large scale randomised evidence of moderate benefits BMJ 1998, 317(7167):1170-1 1114150 9794846
63. Early versus delayed neonatal administration of a synthetic surfactant - the judgment of OSIRIS. The OSIRIS (open study of infants at high risk of or with respiratory insufficiency - the role of surfactant) Collaborative Group Lancet 1992, 340(8832):1363-9 10.1016/ 0140-6736(92)92557-V 1360087
64. Human Immunoglobulin for Intravenous Administration Information Pamphlet, Scottish National Blood Transfusion Service 2000