Clinical trial Recruiting at 2 sites Observational Ages 29 Days to 18

Using gamma globulin to treat critically ill children with inflammatory storms

Official title: Treatment Strategy of Human Gamma Globulin in Children With Severe Infection Complicated With Inflammatory Storm : A Cohort Study

Run by Children's Hospital of Fudan University · NCT04850456 · Data updated 2026-11-12

This study is testing if gamma globulin therapy can help critically ill children with severe inflammatory conditions recover better than those who don’t receive it.

Quick facts

Study typeObservational
Ages29 Days to 18 Years
SexAll
Enrollment200 (estimated)
SponsorChildren's Hospital of Fudan University
Academic / other
Locations2 sites (Shanghai, Shanghai Municipality and 1 other locations)
StatusRecruiting
StartedOctober 1, 2024
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedMarch 16, 2026
Trial IDNCT04850456 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children hospitalized in the PICU with severe infections complicated by inflammatory storms.

Probably not a fit

Patients who are discharged within 48 hours or those without informed consent may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of gamma globulin therapy in critically ill children suffering from inflammatory storms, which can lead to severe complications like multiple organ failure. The researchers will conduct a retrospective analysis of clinical and demographic data from children hospitalized in the Pediatric Intensive Care Unit (PICU) at the Children's Hospital of Fudan University. By comparing outcomes between those treated with gamma globulin and an unused control group, the study seeks to provide insights into the appropriateness of gamma globulin for managing severe infections in this vulnerable population.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic option for managing inflammatory storms in critically ill children, potentially improving survival rates and outcomes.

How similar studies have gone: While the role of gamma globulin in severe infections is debated, this study aims to provide new insights, as similar approaches have not been extensively validated in this specific context.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* children hospitalized in PICU of Children's Hospital of Fudan University
* Children With Severe Infection Complicated With Inflammatory Storm

Exclusion Criteria:

* discharge within 48 hours
* patients without informed consent
* incomplete clinical and demographic data

Where it's running

  • Children's Hospital of Fudan University
    Shanghai, Shanghai Municipality, China
    Recruiting
  • Children's Hospital of Fudan University
    Shanghai, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.