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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03767361
Other study ID # MS2015
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
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
Health authority
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 .

Study Design


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
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