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

Rania Ali El-Farrash

Status and phase: Completed; Early Phase 1

Conditions: Blood Transfusion Complication; Oxidative Stress

Treatments: Biological: packed red blood cells transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03767361

MS2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 35 to 37 weeks old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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65 participants in 2 patient groups

Fresh PRBCs

Active Comparator group

Description:

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

Treatment:

Biological: packed red blood cells transfusion

Old PRBCs

Active Comparator group

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.

Treatment:

Biological: packed red blood cells transfusion