- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03149562
Association of Plasma Transfusions and Invasive Fungal Infection (PT)
October 23, 2022 updated by: Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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)
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Our aim is to explore the association between plasma transfusions and IFI in critically ill neonates
Study Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ma Juan, MD
- Phone Number: 13508300283
- Email: petshi530@vip.163.com
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400042
- Recruiting
- Department of Pediatrics, Daping Hospital, Third Military Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second to 1 day (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All critically ill neonates admitted in hospital.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
plasma transfusions
The critical ill neonates with plasma transfusions
|
These critical ill neonates with plasma transfusions
|
non-plasma transfusions
The critical ill neonates without plasma transfusions
|
These critical ill neonates without plasma transfusions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the rate of invasive fungal infection
Time Frame: 100 days
|
the rate of invasive fungal infection in plasma transfusions group
|
100 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2011
Primary Completion (ANTICIPATED)
December 31, 2023
Study Completion (ANTICIPATED)
December 31, 2023
Study Registration Dates
First Submitted
May 3, 2017
First Submitted That Met QC Criteria
May 9, 2017
First Posted (ACTUAL)
May 11, 2017
Study Record Updates
Last Update Posted (ACTUAL)
October 25, 2022
Last Update Submitted That Met QC Criteria
October 23, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- plasma transfusions
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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