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Efficacy and Pharmacokinetics of Intravenous Immune Globulin Administration to High-Risk Neonates

Efficacy and Pharmacokinetics of Intravenous Immune Globulin Administration to High-Risk Neonates Abstract • Objective. —To determine whether intravenous immune globulin (IVIG) administration modifies the incidence of infections in high-risk neonates. Design. —Randomized, double-blind study. Setting. —Neonatal intensive care unit at a tertiary care center. Participants. —A total of 170 infants were enrolled, 82 of whom received IVIG and 88 of whom received the placebo preparation. Infants were stratified by birth weight into one of three groups (category 1, those weighing less than 1000 g; category 2, those weighing between 1000 and 1500 g; and category 3, those weighing more than 1500 g). Interventions. —Intravenous immune globulin (750 mg/kg of body weight), or albumin placebo was administered within 72 hours of admission to the tertiary care center and every 14 days thereafter until discharge from the neonatal intensive care unit or age 3 months. Serum IgG levels were measured and data collected relating to the incidence of systemic and localized infections and to the course of hospitalization. Measurements and Main Results. —The administration of IVIG had no major side effects and resulted in higher serum IgG levels in infants in all birth weight categories compared with infants receiving the placebo. Systemic infections developed in five IVIG-treated infants and five placebo-treated infants. Administration of immunoglobulin had no significant effect on the rate of localized infections or necrotizing enterocolitis. It also did not affect hospital course of the infants as measured by length of hospitalization or the number of days on assisted ventilation, supplemental oxygen, or antibiotics was required. Conclusions. —The general administration of IVIG using this dosage regimen has limited effects on the clinical course of infants in a neonatal intensive care unit.(AJDC. 1991;145:1233-1238) References 1. Wilson CB. Immunologic basis for increased susceptibility of the neonate to infection . J Pediatr . 1986;108:1-12.Crossref 2. Speer CP, Gahr M, Wieland M, Eber S. Phagocytosis associated functions in neonatal monocyte derived macrophages . Pediatr Res . 19;24:213-216.Crossref 3. Gonzalez LA, Hill HR. The current status of intravenous gammaglobulin use in neonates . Pediatr Infect Dis J . 1989;8:315-322. 4. Cairo MS. Neonatal neutrophil host defence: prospects for immunologic enhancement during neonatal sepsis . AJDC . 1989;143:40-46. 5. Kinney JS, McCray E, Kaplan JE, et al. Risk factors associated with echovirus 11 infection in a hospital nursery . J Pediatr Infect Dis . 1986;5:192-197.Crossref 6. Baley JE. Neonatal sepsis: the potential for immunotherapy . Clin Perinatol . 1988;15:755-771. 7. Stabile A, Sopo SM, Romanelli V, Pastore M, Pesaresi MA. Intravenous immunoglobulin for prophylaxis of neonatal sepsis in premature infants . Arch Dis Child . 1988;63:441-443.Crossref 8. Haque KN, Zaidi MH, Haque SK, Bahakin DH, El-Hazmi M, El-Swailam M. Intravenous immunoglobulin for prevention of sepsis in preterm and low birth weight infants . Pediatr Infect Dis . 1986;5:622-625.Crossref 9. Chirico G, Rondini G, Plebani A, Chiara A, Massa M, Vaazio AG. Intravenous gamma globulin therapy for prophylaxis of infection in high-risk neonates . J Pediatr . 1987;110:437-442.Crossref 10. Christensen RD, Hardman T, Thornton J, Hill HR. A randomized, double-blind, placebo-controlled investigation of the safety of intravenous immune globulin administration to preterm neonates . J Perinatol . 1989;9:126-130. 11. Conray SP, Gillies DRN, Docherty A. Neonatal infection in premature infants and use of human immunoglobulin . Arch Dis Child . 1987;62:1252-1256.Crossref 12. Baker CJ, The Neonatal IVIG Collaborative Study Group. Multicenter trial of intravenous immunoglobulin (IVIG) to prevent late-onset infection in preterm infants: preliminary results. Presented before the Society for Pediatric Research; May 4, 1989; Washington, DC. 13. Weisman LE, Stoll B, Kueser T, et al. Intravenous immunoglobulin (IVIG) prophylaxis of late-onset septicemia in neonates. Presented before the Society for Pediatric Research; May 8,1990; Anaheim, Calif. 14. Clapp DW, Kliegman RM, Baley JE, et al. Use of intravenously administered immune globulin to prevent nosocomial sepsis in low birth weight infants: report of a pilot study . J Pediatr . 1989;115:973-978.Crossref 15. Yamaska K, Nakagawa T, Uno T. Statistical moments in pharmacokinetics . J. Pharmacokinet . 1978;6:547-558.Crossref 16. Battaglia F, Lubchenco LO. A practical classification of newborn infants by weight and gestational age . J Pediatr . 1967;71:159-163.Crossref 17. Fleer A, Senders RC, Visser MR, et al. Septicemia due to coagulase-negative staphylococci in a neonatal intensive care unit: clinical and bacteriological features and contaminated parenteral fluids as a source of sepsis . Pediatr Infect Dis J . 1983;2:426-431.Crossref 18. Noel GJ, Edelson PJ. Staphylococcus epidermidis bacteremia in neonates: further observations and the occurrence of focal infection . Pediatrics . 1984;74:832-837. 19. Bell MJ, Ternberg JL, Feigin RD, et al. Neonatal necrotizing enterocolitis: therapeutic decisions based upon clinical staging . Ann Surg . 1978;187:1-7.Crossref 20. Noya FJD, Rench MA, Courtney JT, Feldman S, Baker CJ. Pharmacokinetics of intravenous immunoglobulin in very low birthweight infants . Pediatr Infect Dis J . 1989;8:759-763.Crossref 21. Waites KB, Crouse DT, Philips JB, Canupp KC, Cassell GH. Ureaplasmal pneumonia and sepsis associated with persistent pulmonary hypertension of the newborn . Pediatrics . 1989;83:79-85. 22. Kyllonen KS, Clapp DW, Kliegman RM, et al. Dosage of intravenously administered immune globulin and dosing interval required to maintain target levels of immunoglobulin G in low birth weight infants . J Pediatr . 1989;11:1013-1021.Crossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png American Journal of Diseases of Children American Medical Association

Efficacy and Pharmacokinetics of Intravenous Immune Globulin Administration to High-Risk Neonates

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References (22)

Publisher
American Medical Association
Copyright
Copyright © 1991 American Medical Association. All Rights Reserved.
ISSN
0002-922X
DOI
10.1001/archpedi.1991.02160110025013
Publisher site
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Abstract

Abstract • Objective. —To determine whether intravenous immune globulin (IVIG) administration modifies the incidence of infections in high-risk neonates. Design. —Randomized, double-blind study. Setting. —Neonatal intensive care unit at a tertiary care center. Participants. —A total of 170 infants were enrolled, 82 of whom received IVIG and 88 of whom received the placebo preparation. Infants were stratified by birth weight into one of three groups (category 1, those weighing less than 1000 g; category 2, those weighing between 1000 and 1500 g; and category 3, those weighing more than 1500 g). Interventions. —Intravenous immune globulin (750 mg/kg of body weight), or albumin placebo was administered within 72 hours of admission to the tertiary care center and every 14 days thereafter until discharge from the neonatal intensive care unit or age 3 months. Serum IgG levels were measured and data collected relating to the incidence of systemic and localized infections and to the course of hospitalization. Measurements and Main Results. —The administration of IVIG had no major side effects and resulted in higher serum IgG levels in infants in all birth weight categories compared with infants receiving the placebo. Systemic infections developed in five IVIG-treated infants and five placebo-treated infants. Administration of immunoglobulin had no significant effect on the rate of localized infections or necrotizing enterocolitis. It also did not affect hospital course of the infants as measured by length of hospitalization or the number of days on assisted ventilation, supplemental oxygen, or antibiotics was required. Conclusions. —The general administration of IVIG using this dosage regimen has limited effects on the clinical course of infants in a neonatal intensive care unit.(AJDC. 1991;145:1233-1238) References 1. Wilson CB. Immunologic basis for increased susceptibility of the neonate to infection . J Pediatr . 1986;108:1-12.Crossref 2. Speer CP, Gahr M, Wieland M, Eber S. Phagocytosis associated functions in neonatal monocyte derived macrophages . Pediatr Res . 19;24:213-216.Crossref 3. Gonzalez LA, Hill HR. The current status of intravenous gammaglobulin use in neonates . Pediatr Infect Dis J . 1989;8:315-322. 4. Cairo MS. Neonatal neutrophil host defence: prospects for immunologic enhancement during neonatal sepsis . AJDC . 1989;143:40-46. 5. Kinney JS, McCray E, Kaplan JE, et al. Risk factors associated with echovirus 11 infection in a hospital nursery . J Pediatr Infect Dis . 1986;5:192-197.Crossref 6. Baley JE. Neonatal sepsis: the potential for immunotherapy . Clin Perinatol . 1988;15:755-771. 7. Stabile A, Sopo SM, Romanelli V, Pastore M, Pesaresi MA. Intravenous immunoglobulin for prophylaxis of neonatal sepsis in premature infants . Arch Dis Child . 1988;63:441-443.Crossref 8. Haque KN, Zaidi MH, Haque SK, Bahakin DH, El-Hazmi M, El-Swailam M. Intravenous immunoglobulin for prevention of sepsis in preterm and low birth weight infants . Pediatr Infect Dis . 1986;5:622-625.Crossref 9. Chirico G, Rondini G, Plebani A, Chiara A, Massa M, Vaazio AG. Intravenous gamma globulin therapy for prophylaxis of infection in high-risk neonates . J Pediatr . 1987;110:437-442.Crossref 10. Christensen RD, Hardman T, Thornton J, Hill HR. A randomized, double-blind, placebo-controlled investigation of the safety of intravenous immune globulin administration to preterm neonates . J Perinatol . 1989;9:126-130. 11. Conray SP, Gillies DRN, Docherty A. Neonatal infection in premature infants and use of human immunoglobulin . Arch Dis Child . 1987;62:1252-1256.Crossref 12. Baker CJ, The Neonatal IVIG Collaborative Study Group. Multicenter trial of intravenous immunoglobulin (IVIG) to prevent late-onset infection in preterm infants: preliminary results. Presented before the Society for Pediatric Research; May 4, 1989; Washington, DC. 13. Weisman LE, Stoll B, Kueser T, et al. Intravenous immunoglobulin (IVIG) prophylaxis of late-onset septicemia in neonates. Presented before the Society for Pediatric Research; May 8,1990; Anaheim, Calif. 14. Clapp DW, Kliegman RM, Baley JE, et al. Use of intravenously administered immune globulin to prevent nosocomial sepsis in low birth weight infants: report of a pilot study . J Pediatr . 1989;115:973-978.Crossref 15. Yamaska K, Nakagawa T, Uno T. Statistical moments in pharmacokinetics . J. Pharmacokinet . 1978;6:547-558.Crossref 16. Battaglia F, Lubchenco LO. A practical classification of newborn infants by weight and gestational age . J Pediatr . 1967;71:159-163.Crossref 17. Fleer A, Senders RC, Visser MR, et al. Septicemia due to coagulase-negative staphylococci in a neonatal intensive care unit: clinical and bacteriological features and contaminated parenteral fluids as a source of sepsis . Pediatr Infect Dis J . 1983;2:426-431.Crossref 18. Noel GJ, Edelson PJ. Staphylococcus epidermidis bacteremia in neonates: further observations and the occurrence of focal infection . Pediatrics . 1984;74:832-837. 19. Bell MJ, Ternberg JL, Feigin RD, et al. Neonatal necrotizing enterocolitis: therapeutic decisions based upon clinical staging . Ann Surg . 1978;187:1-7.Crossref 20. Noya FJD, Rench MA, Courtney JT, Feldman S, Baker CJ. Pharmacokinetics of intravenous immunoglobulin in very low birthweight infants . Pediatr Infect Dis J . 1989;8:759-763.Crossref 21. Waites KB, Crouse DT, Philips JB, Canupp KC, Cassell GH. Ureaplasmal pneumonia and sepsis associated with persistent pulmonary hypertension of the newborn . Pediatrics . 1989;83:79-85. 22. Kyllonen KS, Clapp DW, Kliegman RM, et al. Dosage of intravenously administered immune globulin and dosing interval required to maintain target levels of immunoglobulin G in low birth weight infants . J Pediatr . 1989;11:1013-1021.Crossref

Journal

American Journal of Diseases of Children – American Medical Association

Published: Nov 1, 1991

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