Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03130517 |
| Other study ID # |
assuit university 66 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Early Phase 1
|
| First received |
April 24, 2017 |
| Last updated |
June 26, 2017 |
| Start date |
July 1, 2017 |
| Est. completion date |
December 31, 2018 |
Study information
| Verified date |
June 2017 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
Description:
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 of HDN consists of intensive phototherapy and exchange
transfusion (ET). However, ET is a high-risk invasive procedure associated with a
significant rate of adverse effects .Although the mortality rate associated with ET is
currently reported to be less than 0.3% in term infants , the morbidity rates can reach 74%
and includes catheter-related complications, sepsis, thrombocytopenia and hypocalcemia
Intravenous Immunoglobulin G (IVIG) therapy has been widely used for a variety of
indications in newborn period such as alloimmune neonatal thrombocytopenia and an adjunctive
treatment of neonatal infections. American Academy of Pediatrics, recommends high dose IVIG
(0.5_1 g/kg) as an additional treatment of Rh and ABO hemolytic disease and its use however
there is no consensus on its routine use in ABO hemolytic disease yet .
IVIG "contains a spectrum of antibodies capable of interacting with and altering the
activity of cells of the immune system as well as antibodies capable of reacting with cells
such as erythrocytes". When hemolytic disease occurs, maternal antibodies present in the
infant's blood attach to the antigen receptors on the infant's red blood cells.
Specifically, the maternal antibody attaches its Fc region, the lower portion of the
antigen, to specific immune system cells , such as machrophages, stimulating the destruction
of the antigen-antibody complex and the red blood cell. It has been proposed that IVIG
blocks the Fc receptor and therefore blocks the binding of the antibody to the antigen. With
this blockade, hemolysis no longer occurs.
Neonatal treatment with intravenous immunoglobulin (IVIG) has been suggested as an
altenative therapy to ET for isoimmune hemolytic jaundice to reduce the need for exchange
transfusion and duration of phototherapy and hospitalization in isoimmune hemolytic disease
of the newborn.
