Study the Effect of Blood Transfusion on Oxidant-antioxidant Status in Term and Near-term Neonates
Primary Purpose
Blood Transfusion Complication, Oxidative Stress
Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
packed red blood cells transfusion
Sponsored by
About this trial
This is an interventional health services research trial for Blood Transfusion Complication
Eligibility Criteria
Inclusion Criteria:
- Premature neonates ≤36 weeks in need for blood transfusion.
Exclusion Criteria:
- Critically ill neonates.(perinatal asphaxia,on high setting mechanical ventilation,different types of shock eg ;septic shock and major congenital anomalies)
- Extremely low birth weight neonates(<1000gm birth weight )
- Recipient of blood transfusion before enrollment in the study.
- Neonates planned for exchange transfusion .
Sites / Locations
- Rania Farrash
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Fresh PRBCs
Old PRBCs
Arm Description
Neonates will receive fresh packed red blood cells transfusion within 7 days of donation
Neonates will receive fresh packed red blood cells transfusion older than 7 days yet within the standard range accepted universally will be transfused to this group.
Outcomes
Primary Outcome Measures
malondialdehyde
MDA
total antioxidant capacity
TAC
serum Copper
s.Cu
serum Zinc
s.Zn
serum magnesium
s.Mg
serum iron
s.Fe
serum Calcium
s.Ca
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03767361
Brief Title
Study the Effect of Blood Transfusion on Oxidant-antioxidant Status in Term and Near-term Neonates
Official Title
Study the Effect of Blood Transfusion on Oxidant-antioxidant Status in Term and Near-term Neonates
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 13, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
February 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rania Ali El-Farrash
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Primary aim is to evaluate the effect of blood transfusion on oxidant-antioxidant status in premature neonates. Secondary aim is to assess the effect of the age of transfused red blood cells on the biological markers of oxidative stress.
Detailed Description
Oxidant-antioxidant status will be assessed by measuring total antioxidant capacity (TAC) and malondialdehyde (MDA), as well as antioxidant minerals, in 65 term and near-term neonates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Transfusion Complication, Oxidative Stress
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fresh PRBCs
Arm Type
Active Comparator
Arm Description
Neonates will receive fresh packed red blood cells transfusion within 7 days of donation
Arm Title
Old PRBCs
Arm Type
Active Comparator
Arm Description
Neonates will receive fresh packed red blood cells transfusion older than 7 days yet within the standard range accepted universally will be transfused to this group.
Intervention Type
Biological
Intervention Name(s)
packed red blood cells transfusion
Intervention Description
packed red blood cells transfusion
Primary Outcome Measure Information:
Title
malondialdehyde
Description
MDA
Time Frame
2-3 hours posttransfusion
Title
total antioxidant capacity
Description
TAC
Time Frame
2-3 hours posttransfusion
Title
serum Copper
Description
s.Cu
Time Frame
2-3 hours posttransfusion
Title
serum Zinc
Description
s.Zn
Time Frame
2-3 hours posttransfusion
Title
serum magnesium
Description
s.Mg
Time Frame
2-3 hours posttransfusion
Title
serum iron
Description
s.Fe
Time Frame
2-3 hours posttransfusion
Title
serum Calcium
Description
s.Ca
Time Frame
2-3 hours posttransfusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Premature neonates ≤36 weeks in need for blood transfusion.
Exclusion Criteria:
Critically ill neonates.(perinatal asphaxia,on high setting mechanical ventilation,different types of shock eg ;septic shock and major congenital anomalies)
Extremely low birth weight neonates(<1000gm birth weight )
Recipient of blood transfusion before enrollment in the study.
Neonates planned for exchange transfusion .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rania A. El-Farrash, M.D
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Rania Farrash
City
Cairo
ZIP/Postal Code
11381
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Study the Effect of Blood Transfusion on Oxidant-antioxidant Status in Term and Near-term Neonates
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