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

Early Phase 1

Completed

• Conditions: Blood Transfusion Complication; Oxidative Stress
• Interventions: Biological: packed red blood cells transfusion

• Registration Number: NCT03767361
• Lead Sponsor: Rania Ali El-Farrash

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.

Study Timeline

• Study First Submitted: 2017-08-07
• Study Start: 2018-06-13
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-06
• Primary Completion: 2019-11-01
• Study Completion: 2020-02-26
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Old PRBCs	packed red blood cells transfusion	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.
Fresh PRBCs	packed red blood cells transfusion	Neonates will receive fresh packed red blood cells transfusion within 7 days of donation

Primary Outcome Measures

Name	Time	Method
serum magnesium	2-3 hours posttransfusion	s.Mg
total antioxidant capacity	2-3 hours posttransfusion	TAC
serum Copper	2-3 hours posttransfusion	s.Cu
serum iron	2-3 hours posttransfusion	s.Fe
serum Calcium	2-3 hours posttransfusion	s.Ca
serum Zinc	2-3 hours posttransfusion	s.Zn
malondialdehyde	2-3 hours posttransfusion	MDA

Trial Locations

Locations (1)

Rania Farrash; 🇪🇬 Cairo, Egypt