Clinical Trial: Efficacy of Intravenous Immunoglobulin in Management of Rh and ABO Incompatibility Disease

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Efficacy of Intravenous Immunoglobulin in Management of RH and ABO Incompatibility Disease of Newborn and Its Effect in Decrease Duration of Hospital Stay and Need for Exchange Transfusion

Brief Summary: hemolytic disease of newborn is an important cause of hyperbilirubinemia with significant morbidity and mortality in neonatal period. intravenous immunoglobulin has widely used in management of hemolytic disease of new born

Detailed Summary:

Hemolytic disease of the newborn (HDN) due to red cell alloimmunisation is an important cause of hyperbilirubinemia with significant morbidity in the neonatal period . Hemolytic disease of the newborn has unfortunately continued to contribute to perinatal and neonatal morbidity and mortality in developing countries . The degree to which the fetus is affected correlated with the amount of maternal antibody that cross the placenta .

Hemolysis from ABO incompatibility is one of the most common cause of isoimmune hemolytic disease during neonatal period. Infants with blood group type A or B , carried by blood group type O mother, will have a positive antibody because of maternal anti-A or anti-B transfer in to the fetal circulation. Ten percent of these infants will present with hemolytic disease . Most of the infant presents with unconjugated hyperbilirubinemia in the first 24 h of life and it is rarely a cause in patients who are discharged from nursery and readmit with severe hyperbilirubinemia.

Rh incompatibility can occur when an Rh-negative pregnant mother is exposed to Rh-positive fetal red blood cells secondary to fetomaternal hemorrhage during the course of pregnancy from spontaneous or induced abortion , trauma, invasive obstetric procedures, or normal delivery. As a consequence, blood from the fetal circulation, and, after a significant exposure, sensitization occurs leading to maternal antibody production against the foreign Rh antigen. Once produced, maternal Rh immunoglobulin G (IgG) antibodies may cross freely from the placenta to the fetal circulation, where they form antigen-antibody complexes with Rh- positive fetal erythrocytes and eventually are destroyed, resulting in a fetal alloimmune-induced hemolytic anemia and Jaundice.

Traditional neonatal treatment o
Sponsor: Assiut University

Current Primary Outcome: To measure duration of phototherapy [ Time Frame: Two days ]

to measure how many neonate need for exchange transfusion after one dose of intravenous immunoglobulin and reduction of haemolysis rate which is estimated by reduction in reticulocytic count


Original Primary Outcome: Same as current

Current Secondary Outcome: duration of hospital stay [ Time Frame: Four days ]

neonates with intravenous immunoglobulin is expected to stay less in hospital and decrease duration of phototherapy


Original Secondary Outcome: Same as current

Information By: Assiut University

Dates:
Date Received: April 24, 2017
Date Started: June 1, 2017
Date Completion: December 31, 2018
Last Updated: April 24, 2017
Last Verified: April 2017