Plasma AdministrationPTNCT03149562
Association of Plasma Transfusions and Invasive Fungal Infection
An observational study of Plasma Administration and Invasive Fungal Infection, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
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) Read more about this study
- Who is it for?
- Ages 0 to 24 hours
- Conditions the study is for
- Plasma Administration, Invasive Fungal Infection, Neonatal Infection
- What is being tested?
- plasma transfusions and non-plasma transfusions
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2011to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 24 hours
- All sexes
- No healthy volunteers
- Child
Study population: All critically ill neonates admitted in hospital.
Who may be able to join
- all critically ill neonates admitted in hospital
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pediatrics, Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Juan Ma, physician, 18680887330, zoe330@163.com
About this study
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)
Read the detailed description
Our aim is to explore the association between plasma transfusions and IFI in critically ill neonates
- Being tested
- plasma transfusions, non-plasma transfusions
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasma transfusionsDrug
These critical ill neonates with plasma transfusions
non-plasma transfusionsDrug
These critical ill neonates without plasma transfusions
| Study group | Role | What they receive |
|---|---|---|
| plasma transfusions | The critical ill neonates with plasma transfusions Receives: Drug: plasma transfusions | |
| non-plasma transfusions | The critical ill neonates without plasma transfusions Receives: Drug: non-plasma transfusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of invasive fungal infection
the rate of invasive fungal infection in plasma transfusions group
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start1 Jan 2011
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma AdministrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149562
- Sponsor's protocol ID
- plasma transfusions
- Acronym
- PT
- Status last verified
- Oct 2022
- First submitted
- 3 May 2017
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Plasma Transfusions and Invasive Fungal Infection
- ClinicalTrials.gov ID
- NCT03149562
- Acronym / sponsor ID
- PT / plasma transfusions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
Our aim is to explore the association between plasma transfusions and IFI in critically ill neonates
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plasma transfusions | – | Drug: plasma transfusionsThe critical ill neonates with plasma transfusions |
| non-plasma transfusions | – | Drug: non-plasma transfusionsThe critical ill neonates without plasma transfusions |
Who may qualify
- Ages
- 0 to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All critically ill neonates admitted in hospital.
Key inclusion criteria (1 listed)
- all critically ill neonates admitted in hospital
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plasma transfusionsThese critical ill neonates with plasma transfusions | Drug | plasma transfusions |
| non-plasma transfusionsThese critical ill neonates without plasma transfusions | Drug | non-plasma transfusions |
Primary outcome
the rate of invasive fungal infection
Time frame: 100 days
the rate of invasive fungal infection in plasma transfusions group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plasma Administration and Invasive Fungal Infection, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ma Juan, MD (13508300283, petshi530@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of invasive fungal infection (time frame: 100 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.