Complications of Exchange Transfusion in Neonates
COET
1 other identifier
interventional
50
0 countries
N/A
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2017
CompletedFirst Posted
Study publicly available on registry
June 22, 2017
CompletedStudy Start
First participant enrolled
April 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2019
CompletedJune 22, 2017
June 1, 2017
1 year
June 15, 2017
June 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
serum bilirubin estimation
estimation of serum bilirubin
2 days
Study Arms (2)
blood group
EXPERIMENTALblood is collected for maternal and infant blood group,complete blood count,before, during and after the procedure of exchange transfusion .
serum bilirubin estimation
EXPERIMENTALestimation of serum bilirubin before, during and after the procedure of exchange transfusion .
Interventions
measure levels of total and direct bilirubin before, during and after the procedure of exchange transfusion
Eligibility Criteria
You may qualify if:
- All preterm and full term neonates who need exchange transfusion
You may not qualify if:
- Neonatal sepsis
- Congenital anomalies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 17606558RESULTBhutani 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.
PMID: 15275978RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hanaa Ab Mohamed, Professor
Assiut University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 15, 2017
First Posted
June 22, 2017
Study Start
April 15, 2018
Primary Completion
April 15, 2019
Study Completion
September 15, 2019
Last Updated
June 22, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share