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Study the Effect of Blood Transfusion on Oxidant-antioxidant Status in Term and Near-term Neonates

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ClinicalTrials.gov Identifier: NCT03767361
Recruitment Status : Completed
First Posted : December 6, 2018
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Rania Ali El-Farrash, Ain Shams University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Blood Transfusion Complication Oxidative Stress Biological: packed red blood cells transfusion Early Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Study the Effect of Blood Transfusion on Oxidant-antioxidant Status in Term and Near-term Neonates
Actual Study Start Date : June 13, 2018
Actual Primary Completion Date : November 1, 2019
Actual Study Completion Date : February 26, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Fresh PRBCs
Neonates will receive fresh packed red blood cells transfusion within 7 days of donation
 Biological: packed red blood cells transfusion
packed red blood cells transfusion
Active Comparator: Old PRBCs
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.
 Biological: packed red blood cells transfusion
packed red blood cells transfusion


Outcome Measures
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Primary Outcome Measures :
  1. malondialdehyde [ Time Frame: 2-3 hours posttransfusion ]
    MDA

  2. total antioxidant capacity [ Time Frame: 2-3 hours posttransfusion ]
    TAC

  3. serum Copper [ Time Frame: 2-3 hours posttransfusion ]
    s.Cu

  4. serum Zinc [ Time Frame: 2-3 hours posttransfusion ]
    s.Zn

  5. serum magnesium [ Time Frame: 2-3 hours posttransfusion ]
    s.Mg

  6. serum iron [ Time Frame: 2-3 hours posttransfusion ]
    s.Fe

  7. serum Calcium [ Time Frame: 2-3 hours posttransfusion ]
    s.Ca


Eligibility Criteria
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Ages Eligible for Study:   35 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 .
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03767361


Locations
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Egypt
Rania Farrash
Cairo, Egypt, 11381
Sponsors and Collaborators
Rania Ali El-Farrash
Investigators
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Study Director: Rania A. El-Farrash, M.D Ain Shams University
More Information
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Responsible Party: Rania Ali El-Farrash, Clinical Professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT03767361    
Other Study ID Numbers: MS2015
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Transfusion Reaction
Hematologic Diseases
Immune System Diseases