Efficacy of Intravenous Immunoglobulin in Management of Rh and ABO Incompatibility Disease (IVIG)
Primary Purpose
Haemolysis Neonatal
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
intravenous immunoglobulin
Sponsored by
About this trial
This is an interventional treatment trial for Haemolysis Neonatal focused on measuring hemolysis,newborn
Eligibility Criteria
Inclusion Criteria:
1)Gestational age more than or equal 37 weeks and postnatal age from 48hr-72hr.
2)Anemia with Reticulocytic count 10% 3)Serum total bilirubin around 18mg/dl .
Exclusion Criteria:
- 1)perinatal asphyxia. 2)Congenital malformation. 3)Severe respiratory distress. 4)Sepsis during hospital stay. 5)Metabolic problems . 6)Gestational age less than 37 weeks
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Intervention group
Control group
Arm Description
Use of single dose of intravenous immunoglobulin in a dose 0.5_1gm /kg to intervention group
Control group will recieve phototherapy only
Outcomes
Primary Outcome Measures
To measure duration of phototherapy
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
Secondary Outcome Measures
duration of hospital stay
neonates with intravenous immunoglobulin is expected to stay less in hospital and decrease duration of phototherapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03130517
Brief Title
Efficacy of Intravenous Immunoglobulin in Management of Rh and ABO Incompatibility Disease
Acronym
IVIG
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Anticipated)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemolysis Neonatal
Keywords
hemolysis,newborn
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Model Description
intervention group will recieve intravenous immunoglobulin and phototherapy and control group that will receive phototherapy only
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Other
Arm Description
Use of single dose of intravenous immunoglobulin in a dose 0.5_1gm /kg to intervention group
Arm Title
Control group
Arm Type
Other
Arm Description
Control group will recieve phototherapy only
Intervention Type
Drug
Intervention Name(s)
intravenous immunoglobulin
Other Intervention Name(s)
gammaglobulin
Intervention Description
giving intravenous immunoglobulin to neonates included in inclusion criteria in a dose of 0.5-1 gm
Primary Outcome Measure Information:
Title
To measure duration of phototherapy
Description
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
Time Frame
Two days
Secondary Outcome Measure Information:
Title
duration of hospital stay
Description
neonates with intravenous immunoglobulin is expected to stay less in hospital and decrease duration of phototherapy
Time Frame
Four days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
48 Hours
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1)Gestational age more than or equal 37 weeks and postnatal age from 48hr-72hr.
2)Anemia with Reticulocytic count 10% 3)Serum total bilirubin around 18mg/dl .
Exclusion Criteria:
1)perinatal asphyxia. 2)Congenital malformation. 3)Severe respiratory distress. 4)Sepsis during hospital stay. 5)Metabolic problems . 6)Gestational age less than 37 weeks
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
patients with Rh and ABO incompatibility disease will recieve intravenous immunoglobulin
Learn more about this trial
Efficacy of Intravenous Immunoglobulin in Management of Rh and ABO Incompatibility Disease
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