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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

Tracking Information
First Submitted Date  ICMJE June 15, 2017
First Posted Date  ICMJE June 22, 2017
Last Update Posted Date June 22, 2017
Estimated Study Start Date  ICMJE April 15, 2018
Estimated Primary Completion Date April 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2017)
serum bilirubin estimation [ Time Frame: 2 days ]
estimation of serum bilirubin
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Complications of Exchange Transfusion in Neonates
Official Title  ICMJE Complications of Exchange Transfusion in Neonates
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kernicterus
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: blood group
    blood is collected for maternal and infant blood group,complete blood count,before, during and after the procedure of exchange transfusion .
    Intervention: Diagnostic Test: blood group,complete blood count
  • Experimental: serum bilirubin estimation
    estimation of serum bilirubin before, during and after the procedure of exchange transfusion .
    Intervention: Diagnostic Test: blood group,complete blood count
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 21, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 15, 2019
Estimated Primary Completion Date April 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All preterm and full term neonates who need exchange transfusion

Exclusion Criteria:

  • Neonatal sepsis
  • Congenital anomalies
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 4 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03195049
Other Study ID Numbers  ICMJE COET
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mohamed Zanaty, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hanaa Ab Mohamed, Professor Assiut University
PRS Account Assiut University
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP