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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Haemolysis Neonatal focused on measuring hemolysis,newborn

Eligibility Criteria

48 Hours - 30 Days (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 24, 2017
    Last Updated
    June 26, 2017
    Sponsor
    Assiut University
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    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

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    Efficacy of Intravenous Immunoglobulin in Management of Rh and ABO Incompatibility Disease

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