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

Oxidative Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03767361
• Other study ID #: MS2015
• Status: Completed
• Phase: Early Phase 1
• Start date: June 13, 2018
• Est. completion date: February 26, 2020

Study information

• Verified date: August 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 26, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Weeks to 37 Weeks

Eligibility

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 .

Related Conditions & MeSH terms

• Blood Transfusion Complication
• Oxidative Stress
• Transfusion Reaction

Intervention

Biological:
• packed red blood cells transfusion
packed red blood cells transfusion

Locations

Country	Name	City	State
Egypt	Rania Farrash	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Rania Ali El-Farrash

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	malondialdehyde	MDA	2-3 hours posttransfusion
Primary	total antioxidant capacity	TAC	2-3 hours posttransfusion
Primary	serum Copper	s.Cu	2-3 hours posttransfusion
Primary	serum Zinc	s.Zn	2-3 hours posttransfusion
Primary	serum magnesium	s.Mg	2-3 hours posttransfusion
Primary	serum iron	s.Fe	2-3 hours posttransfusion
Primary	serum Calcium	s.Ca	2-3 hours posttransfusion