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Complications of Exchange Transfusion in Neonates (COET)

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ClinicalTrials.gov Identifier: NCT03195049
Recruitment Status : Unknown
Verified June 2017 by Mohamed Zanaty, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Zanaty, Assiut University

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 .

Condition or disease Intervention/treatment Phase
Kernicterus Diagnostic Test: blood group,complete blood count Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Complications of Exchange Transfusion in Neonates
Estimated Study Start Date : April 15, 2018
Estimated Primary Completion Date : April 15, 2019
Estimated Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: blood group
blood is collected for maternal and infant blood group,complete blood count,before, during and after the procedure of exchange transfusion .
Diagnostic Test: blood group,complete blood count
measure levels of total and direct bilirubin before, during and after the procedure of exchange transfusion
Other Name: measure levels of total and direct bilirubin

Experimental: serum bilirubin estimation
estimation of serum bilirubin before, during and after the procedure of exchange transfusion .
Diagnostic Test: blood group,complete blood count
measure levels of total and direct bilirubin before, during and after the procedure of exchange transfusion
Other Name: measure levels of total and direct bilirubin




Primary Outcome Measures :
  1. serum bilirubin estimation [ Time Frame: 2 days ]
    estimation of serum bilirubin



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All preterm and full term neonates who need exchange transfusion

Exclusion Criteria:

  • Neonatal sepsis
  • Congenital anomalies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195049


Contacts
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Contact: Hanaa Ab Mohamed, Professor 00201120096055 ext Assuit hae50@hotmail.com
Contact: Safwat Mo Abdel-Aziz, Lecturer 00201003918080 ext Assuit Safwatabdelaziz371@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Hanaa Ab Mohamed, Professor Assiut University

Publications of Results:
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Responsible Party: Mohamed Zanaty, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03195049     History of Changes
Other Study ID Numbers: COET
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Zanaty, Assiut University:
hyperbilirubinemia
kernicterus
Additional relevant MeSH terms:
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Kernicterus
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Erythroblastosis, Fetal
Hematologic Diseases
Infant, Newborn, Diseases
Metabolic Diseases
Immune System Diseases
Hyperbilirubinemia
Pathologic Processes
Bilirubin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs