title: Use of cytomegalovirus hyperimmunoglobulin for prevention of congenital cytomegalovirus disease: a retrospective analysis.
abstract: OBJECTIVE
  The aim of this study was to investigate the current prenatal "off-label use" of cytomegalovirus hyperimmunoglobulin (CMV-HIG) in the prevention and treatment of congenital CMV (cCMV) infection, including the long-term outcome of the children.
  
  
  METHODS
  This retrospective observational study comprised mothers and their children, born between January 1, 2006, and October 30, 2010. Prenatal CMV-HIG was administered after diagnosis of primary CMV infection of the mother. Clinical and virological data were collected from maternal and pediatric medical and laboratory reports. Follow-up was 12-36 months after birth.
  
  
  RESULTS
  Forty-two women and 43 children met the study criteria. In total, 40 mothers and six unborn infants received 115 doses of CMV-HIG. The treatment group (TG; CMV-DNA polymerase chain reaction-positive amniotic fluid) included four mothers; the multinomial group (MG; CMV-positive mother and unknown CMV status of fetus) included 38 mothers (39 infants). For the four unborn infants in TG, CMV-HIG was administered either intraumbilically or into the amniotic fluid; three of the four mothers received intravenous CMV-HIG. Three children in TG remained CMV-positive and were asymptomatic at birth and during follow-up. One infant in TG had symptomatic cCMV infection in utero, at birth, and during follow-up. In MG, 37 of 38 women received intravenous CMV-HIG and two of 39 infants received CMV-HIG in utero. In total, 9 (23.1%) of 39 children in MG were positive for cCMV (including a terminated pregnancy). All eight instances of cCMV infection at birth in MG were asymptomatic at birth and during follow-up. The fetus from the terminated pregnancy showed no sonographic symptoms of cCMV infection. No severe side effect occurred in 115 CMV-HIG applications.
  
  
  CONCLUSIONS
  CMV-HIG was well tolerated. Compared with published untreated mother-child pairs, we observed a trend toward a smaller risk for intrauterine CMV transmission following CMV-HIG application. Signs of prenatal cCMV disease were not reversed after CMV-HIG.
authors: Department of Neonatology, University Hospital, Johann Wolfgang Goethe University, Theodor Stern Kai 7, Frankfurt/Main, Germany. h.buxmann.md@web.de
authors: Horst
authors: H
authors: Buxmann
authors: Otto M v
authors: OM
authors: Stackelberg
authors: Rolf L
authors: RL
authors: Schlößer
authors: Gisela
authors: G
authors: Enders
authors: Markus
authors: M
authors: Gonser
authors: Matthias
authors: M
authors: Meyer-Wittkopf
authors: Klaus
authors: K
authors: Hamprecht
authors: Martin
authors: M
authors: Enders
mesh_terms: D000653:Amniotic Fluid / Q000821:virology; D003587:Cytomegalovirus / Q000235:genetics; D003586:Cytomegalovirus Infections / Q000151:congenital* / Q000188:drug therapy / Q000517:prevention & control*; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D005315:Fetal Diseases / Q000188:drug therapy / Q000821:virology; D005500:Follow-Up Studies; D006801:Humans; D007136:Immunoglobulins / Q000008:administration & dosage* / Q000627:therapeutic use; D016756:Immunoglobulins, Intravenous; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control; D016133:Polymerase Chain Reaction; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000821:virology*; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D004279:DNA, Viral; D007136:Immunoglobulins; D016756:Immunoglobulins, Intravenous; C045781:cytomegalovirus-specific hyperimmune globulin