Complications of Exchange Transfusion in Neonates

Not Applicable

• Conditions: Kernicterus
• Interventions: Diagnostic Test: blood group,complete blood count

• Registration Number: NCT03195049
• Lead Sponsor: 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 .

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-15
• Study First Submitted QC: 2017-06-21
• Last Update Submitted: 2017-06-21
• Study First Posted: 2017-06-22
• Last Update Posted: 2017-06-22
• Study Start: 2018-04-15
• Primary Completion: 2019-04-15
• Study Completion: 2019-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• All preterm and full term neonates who need exchange transfusion

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Exclusion Criteria

• Neonatal sepsis
• Congenital anomalies

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
blood group	blood group,complete blood count	blood is collected for maternal and infant blood group,complete blood count,before, during and after the procedure of exchange transfusion .
serum bilirubin estimation	blood group,complete blood count	estimation of serum bilirubin before, during and after the procedure of exchange transfusion .

Primary Outcome Measures

Name	Time	Method
serum bilirubin estimation	2 days	estimation of serum bilirubin