title: An outbreak of neonatal deaths in Brazil associated with contaminated intravenous fluids.
abstract: A nursery outbreak of fever and clinical sepsis resulted in the deaths of 36 neonates in Roraima, Brazil. To determine the cause, epidemiologic studies were performed, along with culture and endotoxin analysis of intravenous (iv) fluids. Affected neonates were more likely to have lower birth weight (2.1 vs. 3.2 kg; P<.01), lower APGAR (activity, pulse, grimace, appearance, and respiration) score at 1 (7 vs. 8; P=.1) or 5 min (8 vs. 9; P=.03), lower gestational age (32 vs. 39 weeks; P=.001), or to receive iv medications (20/20 vs. 2/40; P<.0001). Fever occurred only after iv medication administration. Although culture results of unopened iv medications were negative, endotoxin levels of glucose and distilled water for injection were elevated (3.3 and 1.2 U/mL, respectively). Endotoxin-contaminated iv medications were distributed nationally and may have caused other outbreaks of unexplained death. These results highlight the importance of monitoring both pharmaceutical quality and postmarketing surveillance for adverse events.
authors.affiliation: Hospital Infections Program, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA.
authors.forename: Denise O
authors.initials: DO
authors.lastname: Garrett
authors.forename: L Clifford
authors.initials: LC
authors.lastname: McDonald
authors.forename: Ailton
authors.initials: A
authors.lastname: Wanderley
authors.forename: Celeste
authors.initials: C
authors.lastname: Wanderley
authors.forename: Phyllis
authors.initials: P
authors.lastname: Miller
authors.forename: Janice
authors.initials: J
authors.lastname: Carr
authors.forename: Matthew
authors.initials: M
authors.lastname: Arduino
authors.forename: Lynne
authors.initials: L
authors.lastname: Sehulster
authors.forename: Roger
authors.initials: R
authors.lastname: Anderson
authors.forename: William R
authors.initials: WR
authors.lastname: Jarvis
mesh_terms: D001724:Birth Weight; D001938:Brazil / Q000453:epidemiology; D016022:Case-Control Studies; D015331:Cohort Studies; D004196:Disease Outbreaks; D004340:Drug Contamination; D004731:Endotoxins / Q000032:analysis; D005260:Female; D005334:Fever / Q000453:epidemiology* / Q000209:etiology; D005440:Fluid Therapy / Q000009:adverse effects; D006801:Humans; D007226:Infant Mortality; D007231:Infant, Newborn; D007234:Infant, Premature; D007262:Infusions, Intravenous; D008297:Male; D009725:Nurseries, Hospital; D010288:Parenteral Nutrition; D012307:Risk Factors; D018805:Sepsis / Q000453:epidemiology* / Q000209:etiology
chemical_list: D004731:Endotoxins