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Complications of Exchange Transfusion in Neonates (COET)

Primary Purpose

Kernicterus

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
blood group,complete blood count
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kernicterus focused on measuring hyperbilirubinemia, kernicterus

Eligibility Criteria

1 Day - 4 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All preterm and full term neonates who need exchange transfusion

Exclusion Criteria:

  • Neonatal sepsis
  • Congenital anomalies

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    blood group

    serum bilirubin estimation

    Arm Description

    blood is collected for maternal and infant blood group,complete blood count,before, during and after the procedure of exchange transfusion .

    estimation of serum bilirubin before, during and after the procedure of exchange transfusion .

    Outcomes

    Primary Outcome Measures

    serum bilirubin estimation
    estimation of serum bilirubin

    Secondary Outcome Measures

    Full Information

    First Posted
    June 15, 2017
    Last Updated
    June 21, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03195049
    Brief Title
    Complications of Exchange Transfusion in Neonates
    Acronym
    COET
    Official Title
    Complications of Exchange Transfusion in Neonates
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 15, 2018 (Anticipated)
    Primary Completion Date
    April 15, 2019 (Anticipated)
    Study Completion Date
    September 15, 2019 (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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Exchange transfusion is effective and considered to be safe procedure ; however, it is not without risks. Complications have been reported and mortality rates vary from 0.5 to 3.3%. therefore ,the current recommendation for performing exchange transfusion are based on balance between the risks of encephalopathy and complications related to the procedure .
    Detailed Description
    About 60% of term and 80% of preterm infants have clinical jaundice in the first week after birth but only 2% to 16% of them develop severe hyperbilirubinemia (total serum bilirubin > 25mg/dl) ,which is an emergency because it may cause neonatal bilirubin encephalopathy (kernicterus), which can result in death or irreversible brain damage in survivor. Exchange transfusion is the standard method of therapy for immediate treatment of severe hyperbilirubinemia and prevention of kernicterus. Although the frequency of neonatal exchange transfusion has declined markedly in the past two decades, this procedure is still performed in many countries, especially in those with a high incidence of neonatal hyperbilirubinemia. Exchange transfusion is effective and considered to be safe procedure ; however, it is not without risks. Complications have been reported and mortality rates vary from 0.5 to 3.3%. therefore,the current recommendation for performing exchange transfusion are based on balance between the risks of encephalopathy and complications related to the procedure . Most of these complications are transient, such as severe thrombocytopenia, apnea, hypocalcemia , bradycardia, and hyperkalemia and recovery is expected along with appropriate care and follow up. But serious complications and even death can occurs due to cardiovascular collapse during exchange , necrotizing enterocolitis, bacterial sepsis, and pulmonary hemorrhage that can be avoided by careful cardio-pulmonary and oxygen saturation monitoring.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kernicterus
    Keywords
    hyperbilirubinemia, kernicterus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    blood group
    Arm Type
    Experimental
    Arm Description
    blood is collected for maternal and infant blood group,complete blood count,before, during and after the procedure of exchange transfusion .
    Arm Title
    serum bilirubin estimation
    Arm Type
    Experimental
    Arm Description
    estimation of serum bilirubin before, during and after the procedure of exchange transfusion .
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    blood group,complete blood count
    Other Intervention Name(s)
    measure levels of total and direct bilirubin
    Intervention Description
    measure levels of total and direct bilirubin before, during and after the procedure of exchange transfusion
    Primary Outcome Measure Information:
    Title
    serum bilirubin estimation
    Description
    estimation of serum bilirubin
    Time Frame
    2 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    4 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All preterm and full term neonates who need exchange transfusion Exclusion Criteria: Neonatal sepsis Congenital anomalies
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hanaa Ab Mohamed, Professor
    Phone
    00201120096055
    Ext
    Assuit
    Email
    hae50@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Safwat Mo Abdel-Aziz, Lecturer
    Phone
    00201003918080
    Ext
    Assuit
    Email
    Safwatabdelaziz371@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hanaa Ab Mohamed, Professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    17606558
    Citation
    Steiner LA, Bizzarro MJ, Ehrenkranz RA, Gallagher PG. A decline in the frequency of neonatal exchange transfusions and its effect on exchange-related morbidity and mortality. Pediatrics. 2007 Jul;120(1):27-32. doi: 10.1542/peds.2006-2910.
    Results Reference
    result
    PubMed Identifier
    15275978
    Citation
    Bhutani VK, Johnson LH, Keren R. Diagnosis and management of hyperbilirubinemia in the term neonate: for a safer first week. Pediatr Clin North Am. 2004 Aug;51(4):843-61, vii. doi: 10.1016/j.pcl.2004.03.011.
    Results Reference
    result

    Learn more about this trial

    Complications of Exchange Transfusion in Neonates

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