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.

Study Overview

• Status: Completed
• Conditions: Oxidative Stress; Blood Transfusion Complication
• Intervention / Treatment: Biological: packed red blood cells transfusion

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11381
    • Rania Farrash

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fresh PRBCs; Neonates will receive fresh packed red blood cells transfusion within 7 days of donation	Biological: packed red blood cells transfusion; 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; packed red blood cells transfusion

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rania Ali El-Farrash
• Investigators: Study Director: Rania A. El-Farrash, M.D, ain shams University

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2018
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): February 26, 2020

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hematologic Diseases; Transfusion Reaction
• Other Study ID Numbers: MS2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No