NCT03767361

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

June 13, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2020

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

1.4 years

First QC Date

August 7, 2017

Last Update Submit

August 31, 2020

Conditions

Blood Transfusion ComplicationOxidative Stress

Outcome Measures

Primary Outcomes (7)

  • 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

Study Arms (2)

Fresh PRBCs

ACTIVE COMPARATOR

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

Biological: packed red blood cells transfusion

Old PRBCs

ACTIVE COMPARATOR

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

Interventions

packed red blood cells transfusionBIOLOGICAL

packed red blood cells transfusion

Fresh PRBCsOld PRBCs

Eligibility Criteria

Age35 Weeks - 37 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Premature neonates ≤36 weeks in need for blood transfusion.

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rania Farrash

Cairo, 11381, Egypt

Location

MeSH Terms

Conditions

Transfusion Reaction

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesImmune System Diseases

Study Officials

  • Rania A. El-Farrash, M.D

    Ain Shams University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 7, 2017

First Posted

December 6, 2018

Study Start

June 13, 2018

Primary Completion

November 1, 2019

Study Completion

February 26, 2020

Last Updated

September 2, 2020

Record last verified: 2020-08

Locations

EG(1)