NCT06323226

Brief Summary

This study is conducted in critically ill children with sepsis with a five years follow-up. We aim to investigate the impact of sepsis on long-term outcomes including growth, neurodevelopment, survival rate, quality of life.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress87%
Jan 2019Jun 2027

Study Start

First participant enrolled

January 1, 2019

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

8 years

First QC Date

March 14, 2024

Last Update Submit

January 19, 2026

Conditions

SepsisChildren, Only

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Rate of death in 5-years follow-up

    Five years

Eligibility Criteria

Age0 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

We included critically ill children with sepsis who successfully discharged from pediatric intensive care units and age \< 16 years. Age, sex, and illness severity matched critically ill children would be included as control group. Children with underlying diseases, cancer, and hematologic malignancy would be excluded.

You may qualify if:

  • We included critically ill children with sepsis who successfully discharged from pediatric Intensive care units, age \< 16 years.
  • We also included age, sex, illness severity matched critically ill children as control group.

You may not qualify if:

  • We excluded children with underlying diseases, cancer, hematologic malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Yi Ji, PhD, MD

CONTACT

8618980606865jijiyuanyuan@163.com

Study Design

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

Study Record Dates

First Submitted

March 14, 2024

First Posted

March 21, 2024

Study Start

January 1, 2019

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

January 22, 2026

Record last verified: 2026-01

Locations

CN(1)