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Clinical Trials/NCT03195049
NCT03195049
Unknown
Not Applicable

Complications of Exchange Transfusion in Neonates

Assiut University0 sites50 target enrollmentApril 15, 2018
ConditionsKernicterus

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Kernicterus
Sponsor
Assiut University
Enrollment
50
Primary Endpoint
serum bilirubin estimation
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2018
End Date
September 15, 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Zanaty

Principal Investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

  • All preterm and full term neonates who need exchange transfusion

Exclusion Criteria

  • Neonatal sepsis
  • Congenital anomalies

Outcomes

Primary Outcomes

serum bilirubin estimation

Time Frame: 2 days

estimation of serum bilirubin

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