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Completed

NCT Number: NCT03767361

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

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.

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Key information

Conditions

Blood Transfusion Complication Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Oxidative Stress Transfusion Reaction

Age range

35 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Rania Farrash

Cairo, 11381, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

packed red blood cells transfusion

Biological

packed red blood cells transfusion

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rania Ali El-Farrash

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 6, 2018
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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