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CompletedNCT03767361Updated Sep 2, 2020

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

An Early Phase 1 interventional study of packed red blood cells transfusion in Blood Transfusion Complication and Oxidative Stress, sponsored by Rania Ali El-Farrash. Completed at 1 site in Egypt. Open to participants aged 35 Weeks to 37 Weeks. Per ClinicalTrials.gov, last updated 2020-09-02.

Sponsored by Rania Ali El-Farrash · Early Phase 1, Interventional, and Health services research

Phase
Early Phase 1
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
35 Weeks to 37 Weeks
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Blood Transfusion Complication
  • Oxidative Stress

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03

In context

Transfusion Reaction

56 studies on the registry are indexed under Transfusion Reaction; 12 are open to participants now.

This study's enrollment of 65 is close to the median of 71 across 23 interventional studies indexed under Transfusion Reaction.

Browse Transfusion Reaction studies →

Lead sponsor

Rania Ali El-Farrash is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Weeks to 37 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Premature neonates ≤36 weeks in need for blood transfusion.

Exclusion criteria

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 .
05

Study design

Phase
Early Phase 1
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
65 participants (actual)

Study arms

  • Active comparator
    Fresh PRBCs

    Neonates will receive fresh packed red blood cells transfusion within 7 days of donation

    Biological: 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

Interventions

  • Biologicalpacked red blood cells transfusion

    packed red blood cells transfusion

06

What researchers measure

Primary outcomes

  1. malondialdehyde

    MDA

    Time frame: 2-3 hours posttransfusion

  2. total antioxidant capacity

    TAC

    Time frame: 2-3 hours posttransfusion

  3. serum Copper

    s.Cu

    Time frame: 2-3 hours posttransfusion

  4. serum Zinc

    s.Zn

    Time frame: 2-3 hours posttransfusion

  5. serum magnesium

    s.Mg

    Time frame: 2-3 hours posttransfusion

  6. serum iron

    s.Fe

    Time frame: 2-3 hours posttransfusion

  7. serum Calcium

    s.Ca

    Time frame: 2-3 hours posttransfusion

07

Study locations

1 site
  • Rania Farrash
    Cairo, 11381, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03767361
Lead sponsor
Rania Ali El-Farrash
Responsible party
Rania Ali El-Farrash (Clinical Professor, Ain Shams University) — Sponsor-investigator
First posted
Dec 6, 2018
Start date
Jun 13, 2018
Primary completion
Nov 1, 2019
Completion
Feb 26, 2020
Last update
Sep 2, 2020

Study contacts

Rania A. El-Farrash, M.D
study director · Ain Shams University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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