Using gamma globulin to treat critically ill children with inflammatory storms
Treatment Strategy of Human Gamma Globulin in Children With Severe Infection Complicated With Inflammatory Storm : A Cohort Study
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 29 Days to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Trial ID | NCT04850456 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children hospitalized in the PICU with severe infections complicated by inflammatory storms.
Not a fit: Patients who are discharged within 48 hours or those without informed consent may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.