Neonatal Cord Blood Screening for HDN

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05617612
Collaborator
(none)
400
13

Study Details

Study Description

Brief Summary

To evaluate the diagnostic efficiency of antibodies screening in cord blood for detection of HDN.

To help finding the antigen negative blood in a timely manner and reduce the morbidities and mortalities of HDN

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Hemolytic disease of the newborn (HDN) refers to fetal or neonatal alloimmune hemolysis caused by red blood cell antibodies due to incompatible maternal and fetal or neonatal blood types. A French midwife first described the disorder in 1609; however, it was not until the 1950s when the underlying cause was clarified. The pathogenesis of HDN begins with the attack of fetal red blood cells (RBCs) by maternal antibodies due to incompatibility of maternal and fetal blood. Immunologically, antibody secretion initially starts with Immunoglobulin M (IgM), which cannot cross the placental barrier, but is then followed by isotype switching, which produces Immunoglobulin G (IgG) antibodies. IgG antibodies can cross the placental barrier, and they do so during the second and or subsequent pregnancies, attacking the fetal RBCs and causing hemolysis and associated complications such as Hydrops fetalis and jaundice. HDN can occur due to Rh antigens, most commonly the D antigen, and A,B and O RBCs antigens (ABO) antigens. Rh(D)-HDN has decreased since the introduction of antenatal and postpartum Rh immunoglobulin. Therefore, the prevalence of HDN, nowadays, varies according to blood type incompatibility. ABO incompatibility is the most common cause of HDN and Rh (D) antigen is the second most common cause.[8] Rh (C, c, E, e) antigen incompatibility occurs occasionally. Several other alloantibodies have also been reported to be associated with hemolytic diseases, including Kidd, Diego, Duffy, Kell and Anti-Mur. Minor blood group incompatibility due to blood groups other than Rh(D), although an uncommon cause of neonatal hyperbilirubinemia, has the potential to cause severe hyperbilirubinemia and its sequelae in infants, if left undiagnosed and untreated. Therefore, identification of at-risk cases will help clinicians to reduce neonatal morbidity and will result in better patient management

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Neonatal Alloantibodies in Cord Blood for Early Detection of Hemolytic Disease of Newborn
    Anticipated Study Start Date :
    Dec 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Jan 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. evaluate the diagnostic efficiency of antibodies screening in cord blood for detection of HDN [Baseline]

      Early detection of HDN through antibodies screening would help finding the antigen negative blood in a timely manner and reduce the morbidities and mortalities

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 3 Days
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Full term neonates >/= 37 weeks.

    • ABO blood compatible mother and neonate

    Exclusion Criteria:
    • Preterm neonates < 37 weeks.

    • ABO incompatibility between mother and neonate

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Shimaaa Abd El-Aleem, Neonatal Alloantibodies in cord blood for early detection of Hemolytic disease of newborn, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05617612
    Other Study ID Numbers:
    • HDN screening
    First Posted:
    Nov 15, 2022
    Last Update Posted:
    Nov 15, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 15, 2022