Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2018-04-15
2019-09-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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blood group
blood is collected for maternal and infant blood group,complete blood count,before, during and after the procedure of exchange transfusion .
blood group,complete blood count
measure levels of total and direct bilirubin before, during and after the procedure of exchange transfusion
serum bilirubin estimation
estimation of serum bilirubin before, during and after the procedure of exchange transfusion .
blood group,complete blood count
measure levels of total and direct bilirubin before, during and after the procedure of exchange transfusion
Interventions
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blood group,complete blood count
measure levels of total and direct bilirubin before, during and after the procedure of exchange transfusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Congenital anomalies
1 Day
4 Weeks
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Mohamed Zanaty
Principal Investigator
Principal Investigators
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Hanaa Ab Mohamed, Professor
Role: STUDY_CHAIR
Assiut University
Central Contacts
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References
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Steiner LA, Bizzarro MJ, Ehrenkranz RA, Gallagher PG. A decline in the frequency of neonatal exchange transfusions and its effect on exchange-related morbidity and mortality. Pediatrics. 2007 Jul;120(1):27-32. doi: 10.1542/peds.2006-2910.
Bhutani VK, Johnson LH, Keren R. Diagnosis and management of hyperbilirubinemia in the term neonate: for a safer first week. Pediatr Clin North Am. 2004 Aug;51(4):843-61, vii. doi: 10.1016/j.pcl.2004.03.011.
Other Identifiers
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COET
Identifier Type: -
Identifier Source: org_study_id
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