| Registry | NCT03195049, acronym COET |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 50 (Estimated) |
| Sponsor | Assiut University (Other) |
| Conditions | Kernicterus |
| Interventions | blood group,complete blood count (Diagnostic test) |
| Dates | start 2018-04-15 (estimated), primary completion 2019-04-15 (estimated), completion 2019-09-15 (estimated), first posted 2017-06-22, last updated 2017-06-22 |
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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 .
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| blood group | Experimental | Diagnostic Test: 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 | Experimental | Diagnostic Test: blood group,complete blood count | estimation of serum bilirubin before, during and after the procedure of exchange transfusion . |
Sex: All, ages: 1 Day to 4 Weeks
Inclusion Criteria: * All preterm and full term neonates who need exchange transfusion Exclusion Criteria: * Neonatal sepsis * Congenital anomalies