Efficacy of High-dose Intravenous Immunoglobulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease
Condition: Hyperbilirubinemia; Erythroblastosis, Fetal
MeSH terms: Erythroblastosis, Fetal; Hyperbilirubinemia
Intervention: Intravenous Immunoglobulin; Normal saline solution
Intervention description: Intravenous Immunoglobulin; Normal saline solution 10 ml/Kg
Intervention MeSH terms: Pharmaceutical Solutions; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 92.0
Sex: All
Minimum age: 1 Hour
Maximum age: 6 Hours
Healthy volunteers: No
Keywords: Immunoglobulins, Intravenous; Hyperbilirubinemia; Erythroblastosis, Fetal; Exchange Transfusion, Whole Blood

Summary:

      The use of intravenous immunoglobulin G (IVIG) therapy has been reported in
      hyperbilirubinemia of Rh hemolytic disease but we don't have enough evidences for it. Human
      Immunoglobulin is considered an alternative to delay the hemolytic process and consequently
      reduce the number of exchange transfusions and transfusions of red cells concentrate, thus
      diminishing the risk of transmitting transfusional therapies-related diseases. OBJECTIVE: To
      determine the effect of IVIG in decreasing the incidence and severity of neonatal immune
      hemolytic jaundice due to Rh hemolytic disease reducing the need for exchange transfusion as
      a primary goal in these babies. METHODS: This will be a randomized, double blind, clinical
      trial involving all newborns with risk of significant hyperbilirubinemia due to direct
      Coombs-positive Rh hemolytic disease. The primary goal will be need for exchange transfusion
      and others are: incidence of late anemia, kernicterus and deafness Babies were randomly
      assigned into two groups: group 1 (study group) received phototherapy plus IVIG (500 mg/kg);
      and group 2 (control group) received phototherapy and normal saline solution (10 ml/Kg) in
      the first 6 hours of life. Exchange transfusion was carried out in any group if at any time
      the bilirubin level reached 340 micromol/l (20 mg/dl) or more, or rose by 8.5 micromol/l per
      h (0.5 mg/dl per h). Adverse effects will be related in two groups. Parents informed consent
      will be asked in pre-natal time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All newborns with a gestational age equal or higher than 32 weeks, with a Rh (D)
             positive blood type, children of sensitized Rh (D) negative mothers, regardless if
             they were submitted or not to an intra-uterus transfusion.

        Exclusion Criteria:

          -  Newborns in serious condition, hydropic, hemodynamically instable or with indication
             for exchange transfusion at birth. The indications for exchange transfusion at birth
             are: presence of bilirubin in the umbilical cord higher or equal to 4mg%; hydrops,
             cardiac insufficiency secondary to severe anemia.