Association of Plasma Transfusions and Invasive Fungal In... | NCT03149562

Studies
Association of Plasma Transfusions and Invasive Fungal Infection

NCT03149562

Sponsor

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

Status

Unknown status

Last Update Posted

Oct 25, 2022Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Plasma Administration
Invasive Fungal Infection
Neonatal Infection

Interventions

plasma transfusions
non-plasma transfusions

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2011Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

May 3, 2017

First Submission Date that Met QC Criteria

May 9, 2017

First Posted Date

May 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2022

Last Update Posted Date

Oct 25, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ma Juan, director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityPrincipal Investigator

Lead Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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)

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
plasma transfusions		The critical ill neonates with plasma transfusions	Drug: plasma transfusions
non-plasma transfusions		The critical ill neonates without plasma transfusions	Drug: non-plasma transfusions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
plasma transfusions	Drug	These critical ill neonates with plasma transfusions	plasma transfusions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the rate of invasive fungal infection	the rate of invasive fungal infection in plasma transfusions group	100 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Hours

Maximum Age

24 Hours

Standard Ages

Child

Study Population

All critically ill neonates admitted in hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ma Juan, MD	Contact	13508300283		petshi530@vip.163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pediatrics, Daping Hospital, Third Military Medical University	Recruiting	Chongqing	Chongqing Municipality	400042	China

Condition Browse Module

MeSH Terms

ID	Term
D000072742	Invasive Fungal Infections

Ancestor Terms

ID	Term
D009181	Mycoses
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided