Document Detail

Intravenous immune globulin prophylaxis of late-onset sepsis in premature neonates.
MedLine Citation:
PMID:  7996367     Owner:  NLM     Status:  MEDLINE    
To determine whether a single dose of intravenously administered immune globulin (IVIG) decreases late-onset sepsis in premature infants, we prospectively entered 753 neonates with birth weight 500 to 2000 gm, gestation < or = 34 weeks, and age < or = 12 hours into a multicenter, double-blind, controlled trial. Infants were randomly selected to receive a single intravenous infusion, 10 ml/kg, of either IVIG (500 mg/kg) or albumin (5 mg/kg) and were observed for 8 weeks for infection. Maternal and neonatal risk factors for infection did not differ between groups. Although serum IgG values before infusion were related to gestation (R = 0.62), the change in serum IgG or half-life of IgG after IVIG infusion was not (R < or = 0.09). The serum IgG concentration was increased (p < 0.05) in IVIG-treated patients for 8 weeks. There were 88 episodes of late-onset sepsis in 79 neonates (10.5%). Causative organisms included the following: Staphylococcus epidermidis (37 episodes), Enterococcus (9), Staphylococcus aureus (7), Candida (6), Escherichia coli (6), and multiple organisms (11). Sepsis, death, and death as a result of infection were unaffected by treatment. We conclude that a single infusion of IVIG, 500 mg/kg, shortly after birth was not effective prophylaxis for late-onset infection in premature neonates. Future studies of late-onset sepsis prophylaxis should consider IVIG with known pathogen-specific antibody concentrations against organisms causing these infections, in particular S. epidermidis.
L E Weisman; B J Stoll; T J Kueser; T T Rubio; C G Frank; H S Heiman; K N Subramanian; C T Hankins; D F Cruess; V G Hemming
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Journal of pediatrics     Volume:  125     ISSN:  0022-3476     ISO Abbreviation:  J. Pediatr.     Publication Date:  1994 Dec 
Date Detail:
Created Date:  1995-01-17     Completed Date:  1995-01-17     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0375410     Medline TA:  J Pediatr     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  922-30     Citation Subset:  AIM; IM    
Department of Pediatrics, Uniformed Services University of the Health Sciences, Bethesda, Maryland.
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MeSH Terms
Albumins / therapeutic use*
Bacteremia / epidemiology,  microbiology,  prevention & control*
Dose-Response Relationship, Drug
Double-Blind Method
Follow-Up Studies
Immunoglobulin G / blood,  drug effects
Immunoglobulins, Intravenous / therapeutic use*
Infant, Newborn
Infant, Premature, Diseases / epidemiology,  microbiology,  prevention & control*
Infusions, Intravenous
Risk Factors
Time Factors
Reg. No./Substance:
0/Albumins; 0/Immunoglobulin G; 0/Immunoglobulins, Intravenous

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