Complications of Exchange Transfusion in Neonates (COET)
Primary Purpose
Kernicterus
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
blood group,complete blood count
Sponsored by
About this trial
This is an interventional treatment trial for Kernicterus focused on measuring hyperbilirubinemia, kernicterus
Eligibility Criteria
Inclusion Criteria:
- All preterm and full term neonates who need exchange transfusion
Exclusion Criteria:
- Neonatal sepsis
- Congenital anomalies
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
blood group
serum bilirubin estimation
Arm Description
blood is collected for maternal and infant blood group,complete blood count,before, during and after the procedure of exchange transfusion .
estimation of serum bilirubin before, during and after the procedure of exchange transfusion .
Outcomes
Primary Outcome Measures
serum bilirubin estimation
estimation of serum bilirubin
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03195049
Brief Title
Complications of Exchange Transfusion in Neonates
Acronym
COET
Official Title
Complications of Exchange Transfusion in Neonates
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2018 (Anticipated)
Primary Completion Date
April 15, 2019 (Anticipated)
Study Completion Date
September 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kernicterus
Keywords
hyperbilirubinemia, kernicterus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
blood group
Arm Type
Experimental
Arm Description
blood is collected for maternal and infant blood group,complete blood count,before, during and after the procedure of exchange transfusion .
Arm Title
serum bilirubin estimation
Arm Type
Experimental
Arm Description
estimation of serum bilirubin before, during and after the procedure of exchange transfusion .
Intervention Type
Diagnostic Test
Intervention Name(s)
blood group,complete blood count
Other Intervention Name(s)
measure levels of total and direct bilirubin
Intervention Description
measure levels of total and direct bilirubin before, during and after the procedure of exchange transfusion
Primary Outcome Measure Information:
Title
serum bilirubin estimation
Description
estimation of serum bilirubin
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
4 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All preterm and full term neonates who need exchange transfusion
Exclusion Criteria:
Neonatal sepsis
Congenital anomalies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hanaa Ab Mohamed, Professor
Phone
00201120096055
Ext
Assuit
Email
hae50@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Safwat Mo Abdel-Aziz, Lecturer
Phone
00201003918080
Ext
Assuit
Email
Safwatabdelaziz371@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanaa Ab Mohamed, Professor
Organizational Affiliation
Assiut University
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17606558
Citation
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.
Results Reference
result
PubMed Identifier
15275978
Citation
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.
Results Reference
result
Learn more about this trial
Complications of Exchange Transfusion in Neonates
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