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Clinical Trial 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 .


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03195049
Study type Interventional
Source Assiut University
Contact Hanaa Ab Mohamed, Professor
Phone 00201120096055
Email hae50@hotmail.com
Status Not yet recruiting
Phase N/A
Start date April 15, 2018
Completion date September 15, 2019

See also
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Recruiting NCT06058910 - Bilistick Point-of-care System 2.0 Bilirubin Validation
Completed NCT02691156 - Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants
Terminated NCT03534466 - Evaluation of Long-Term Gait Development in Infants With Neonatal Encephalopathy Using Infant Treadmill N/A
Withdrawn NCT03527498 - Evaluation of Long-term Neurodevelopment in Neonatal Encephalopathy by Infant Treadmill N/A