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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03149562
Other study ID # plasma transfusions
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2011
Est. completion date December 31, 2023

Study information

Verified date October 2022
Source Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Contact Ma Juan, MD
Phone 13508300283
Email petshi530@vip.163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Although lacking strong evidences, plasma transfusions are commonly used in critically ill neonates. To date, the relationships between plasma transfusions and nosocomial infection remain controversial and no study has reported the relationships between plasma transfusion and invasive fungal infection (IFI)


Description:

Our aim is to explore the association between plasma transfusions and IFI in critically ill neonates


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 0 Hours to 24 Hours
Eligibility Inclusion Criteria: - all critically ill neonates admitted in hospital Exclusion Criteria: - severe congenital abnormality; - died within 24 hours or left neonatal intensive care unit within 24 hours according to their parents' decisions; - parents' decision not to participate.

Study Design


Intervention

Drug:
plasma transfusions
These critical ill neonates with plasma transfusions
non-plasma transfusions
These critical ill neonates without plasma transfusions

Locations

Country Name City State
China Department of Pediatrics, Daping Hospital, Third Military Medical University Chongqing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the rate of invasive fungal infection the rate of invasive fungal infection in plasma transfusions group 100 days
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