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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03767361
Enrollment
65
Registered
2018-12-06
Start date
2018-06-13
Completion date
2020-02-26
Last updated
2020-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Transfusion Complication, Oxidative Stress

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.

Interventions

BIOLOGICALpacked red blood cells transfusion

packed red blood cells transfusion

Sponsors

Rania Ali El-Farrash
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Weeks to 37 Weeks
Healthy volunteers
No

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 .

Design outcomes

Primary

MeasureTime frameDescription
malondialdehyde2-3 hours posttransfusionMDA
total antioxidant capacity2-3 hours posttransfusionTAC
serum Copper2-3 hours posttransfusions.Cu
serum Zinc2-3 hours posttransfusions.Zn
serum magnesium2-3 hours posttransfusions.Mg
serum iron2-3 hours posttransfusions.Fe
serum Calcium2-3 hours posttransfusions.Ca

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026