title: Immunoglobulins in Neonates with Rhesus Hemolytic Disease of the Fetus and Newborn: Long-Term Outcome in a Randomized Trial.
abstract: OBJECTIVE
  Prophylactic intravenous immunoglobulin (IVIg) does neither reduce the need for exchange transfusion nor the rates of other adverse neonatal outcomes in neonates with rhesus hemolytic disease of the fetus and newborn (rhesus HDFN) according to our randomized controlled trial analysis. Our objective was to assess the long-term neurodevelopmental outcome in the children included in the trial and treated with either IVIg or placebo.
  
  
  METHODS
  All families of the children included in the trial were asked to participate in this follow-up study. The long-term neurodevelopmental outcome in children at least 2 years of age was assessed using standardized tests. The primary outcome was the incidence of neurodevelopmental impairment defined as at least one of the following: cerebral palsy, severe cognitive and/or motor developmental delay (with a test score of less than -2 SD), bilateral deafness or blindness.
  
  
  RESULTS
  Sixty-six of the 80 children (82.5%) who had been recruited to the initial randomized controlled trial participated in the follow-up study. The children were assessed at a median age of 4 years (range 2-7). The median cognitive score was 96 (range 68-118) in the IVIg group and 97 (range 66-118) in the placebo group (p = 0.79). There was no difference in the rate of neurodevelopmental impairment between the IVIg and the placebo group [3% (1/34) vs. 3% (1/32); p = 1.00].
  
  
  CONCLUSIONS
  The long-term neurodevelopmental outcome in children treated with IVIg was not different from that in children treated with placebo. Standardized long-term follow-up studies with large enough case series and sufficient power are needed to replicate these findings.
authors.affiliation: Division of Neonatology, Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands.
authors.forename: Jeanine M M
authors.initials: JM
authors.lastname: van Klink
authors.forename: Suzanne J
authors.initials: SJ
authors.lastname: van Veen
authors.forename: Vivianne E H J
authors.initials: VE
authors.lastname: Smits-Wintjens
authors.forename: Irene T M
authors.initials: IT
authors.lastname: Lindenburg
authors.forename: Monique
authors.initials: M
authors.lastname: Rijken
authors.forename: Dick
authors.initials: D
authors.lastname: Oepkes
authors.forename: Enrico
authors.initials: E
authors.lastname: Lopriore
mesh_terms: D002675:Child, Preschool; D004899:Erythroblastosis, Fetal / Q000209:etiology / Q000628:therapy*; D005078:Exchange Transfusion, Whole Blood / Q000009:adverse effects; D005500:Follow-Up Studies; D006801:Humans; D007116:Immunization, Passive / Q000009:adverse effects / Q000379:methods*; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use; D007231:Infant, Newborn; D007361:Intelligence Tests; D000069451:Long Term Adverse Effects; D065886:Neurodevelopmental Disorders / Q000150:complications*; D010038:Otorhinolaryngologic Diseases / Q000150:complications / Q000453:epidemiology / Q000517:prevention & control; D012203:Rh Isoimmunization / Q000150:complications*; D016896:Treatment Outcome
chemical_list: D016756:Immunoglobulins, Intravenous