NCT03149562

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)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 11, 2017

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

13 years

First QC Date

May 3, 2017

Last Update Submit

October 23, 2022

Conditions

Plasma AdministrationInvasive Fungal InfectionNeonatal Infection

Outcome Measures

Primary Outcomes (1)

  • the rate of invasive fungal infection

    the rate of invasive fungal infection in plasma transfusions group

    100 days

Study Arms (2)

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

plasma transfusionsDRUG

These critical ill neonates with plasma transfusions

plasma transfusions
non-plasma transfusionsDRUG

These critical ill neonates without plasma transfusions

non-plasma transfusions

Eligibility Criteria

Age0 Hours - 24 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All critically ill neonates admitted in hospital.

You may qualify if:

  • all critically ill neonates admitted in hospital

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

Invasive Fungal Infections

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Central Study Contacts

Ma Juan, MD

CONTACT

13508300283petshi530@vip.163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 11, 2017

Study Start

January 1, 2011

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

October 25, 2022

Record last verified: 2022-10

Locations

CN(1)