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The efficacy of the use of intravenous human immunoglobulin in Brazilian newborns with rhesus hemolytic disease: a randomized double-blind trial

Authors

  • Maria Cristina Santos,

    Corresponding author
    1. From the Transfusion Medicine Unit, Neonatology, the Clinical Research Unit, and Epidemiology, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.
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  • Cynthia Sá,

    1. From the Transfusion Medicine Unit, Neonatology, the Clinical Research Unit, and Epidemiology, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.
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  • Saint Clair Gomes Jr,

    1. From the Transfusion Medicine Unit, Neonatology, the Clinical Research Unit, and Epidemiology, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.
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  • Luiz Antonio Camacho,

    1. From the Transfusion Medicine Unit, Neonatology, the Clinical Research Unit, and Epidemiology, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.
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  • Maria Elisabeth Moreira

    1. From the Transfusion Medicine Unit, Neonatology, the Clinical Research Unit, and Epidemiology, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.
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Maria Elisabeth Moreira, PhD, Neonatology, Oswaldo Cruz Foundation, Avenida Rui Barbosa 716-Flamengo, Rio de Janeiro RJ, Brazil CEP 22250-020; e-mail: bebethiff@gmail.com.

Abstract

BACKGROUND: The purpose of this study was to evaluate the efficacy of intravenous human immunoglobulin (IVIG) in the presence of high-intensity phototherapy in decreasing the need for exchange transfusion in newborns with rhesus hemolytic disease.

STUDY DESIGN AND METHODS: We performed a randomized, double-blind, placebo-controlled trial. The trial included D+ newborns born at 32 weeks of gestational age or later with a positive direct antiglobulin test and whose mothers were Rh-alloimmunized and did or did not receive intrauterine transfusion. The newborns were randomly assigned to receive either IVIG at a dose of 500 mg/kg or placebo (saline solution, 10 mL/kg) during the first 6 hours of life. The primary outcome was the need for exchange transfusion. The criteria for exchange transfusion were total serum bilirubin (TSB) level at or above 340 µmol/L (20 mg/dL) or increasing by 8.5 µmol/L/hr (0.5 mg/dL/hr) despite intensive phototherapy.

RESULTS: The trial included 92 newborns. There was no difference in the rate of exchange transfusion between groups: 6 of 46 (13%) in the IVIG group versus 7 of 46 (15.2%) in the placebo group (p = 0.765). There were no significant differences between groups with respect to their need for exchange transfusion, phototherapy time, peak bilirubin, or length of hospital stay. There were no adverse events related to the drug or the form of administration.

CONCLUSION: Nonspecific human immunoglobulin was not effective in preventing the need for exchange transfusion in neonates with rhesus hemolytic disease.

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