title: Intravenous immunoglobulin in neonates with rhesus hemolytic disease: a randomized controlled trial.
abstract: BACKGROUND
  Despite limited data, international guidelines recommend the use of intravenous immunoglobulin (IVIg) in neonates with rhesus hemolytic disease.
  
  
  OBJECTIVE
  We tested whether prophylactic use of IVIg reduces the need for exchange transfusions in neonates with rhesus hemolytic disease.
  
  
  METHODS
  We performed a randomized, double-blind, placebo-controlled trial in neonates with rhesus hemolytic disease. After stratification for treatment with intrauterine transfusion, neonates were randomly assigned for IVIg (0.75 g/kg) or placebo (5% glucose). The primary outcome was the rate of exchange transfusions. Secondary outcomes were duration of phototherapy, maximum bilirubin levels, and the need of top-up red-cell transfusions.
  
  
  RESULTS
  Eighty infants were included in the study, 53 of whom (66%) were treated with intrauterine transfusion(s). There was no difference in the rate of exchange transfusions between the IVIg and placebo groups (7 of 41 [17%] vs 6 of 39 [15%]; P = .99) and in the number of exchange transfusions per patient (median [range]: 0 [0-2] vs 0 [0-2]; P = .90) or in duration of phototherapy (4.7 [1.8] vs 5.1 [2.1] days; P = .34), maximum bilirubin levels (14.8 [4.7] vs 14.1 [4.9] mg/dL; P = .52), and proportion of neonates who required top-up red-cell transfusions (34 of 41 [83%] vs 34 of 39 [87%]; P = .76).
  
  
  CONCLUSIONS
  Prophylactic IVIg does not reduce the need for exchange transfusion or the rates of other adverse neonatal outcomes. Our findings do not support the use of IVIg in neonates with rhesus hemolytic disease.
authors.affiliation: Division of Neonatology, Department of Pediatrics, Leiden University Medical Center, Leiden, Netherlands. v.smits@lumc.nl
authors.forename: Vivianne E H J
authors.initials: VE
authors.lastname: Smits-Wintjens
authors.forename: Frans J
authors.initials: FJ
authors.lastname: Walther
authors.forename: Mirjam E A
authors.initials: ME
authors.lastname: Rath
authors.forename: Irene T M
authors.initials: IT
authors.lastname: Lindenburg
authors.forename: Arjan B
authors.initials: AB
authors.lastname: te Pas
authors.forename: Christine M
authors.initials: CM
authors.lastname: Kramer
authors.forename: Dick
authors.initials: D
authors.lastname: Oepkes
authors.forename: Anneke
authors.initials: A
authors.lastname: Brand
authors.forename: Enrico
authors.initials: E
authors.lastname: Lopriore
mesh_terms: D001663:Bilirubin / Q000097:blood; D001805:Blood Transfusion, Intrauterine; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D004899:Erythroblastosis, Fetal / Q000188:drug therapy*; D017707:Erythrocyte Transfusion; D005078:Exchange Transfusion, Whole Blood; D005260:Female; D006452:Hemoglobinometry; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D009426:Netherlands; D010789:Phototherapy; D011446:Prospective Studies; D012203:Rh Isoimmunization / Q000188:drug therapy*
chemical_list: D007074:Immunoglobulin G; D001663:Bilirubin