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 type | Observational |
|---|---|
| Ages | 29 Days to 18 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT04850456 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
- Study coordinator: Guoping Lu, Doctor
- Email: 13788904150@163.com
- Phone: 13788904150
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.