NCT04850456 Treatment Strategy of Human Gamma Globulin on the Therapy for Intensively Ill Children With Inflammatory Storm
| NCT ID | NCT04850456 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Fudan University |
| Condition | Critical Illness |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-10-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The inflammatory storm in critically ill patients releases cytokines, causing systemic immune damage, which may be an important cause of multiple organ failure and even death. Inflammatory storms exacerbate the deterioration of the disease in those children. Gamma globulin may be an effective option to control inflammatory storms. However, this preliminary result needs to be verified from reliable and representative RCTs. In our study, we conducted a retrospective study on the use of gamma globulin and an unused control group. At present, the indications of IVIG are mainly focused on the neuromuscular system and the blood system. We hope to establish a more appropriate and operable evaluation table for the suitability of gamma globulin for clinical use.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04850456 clinical trial?
This trial is open to participants of all sexes, aged 29 Days or older, up to 18 Years, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04850456 currently recruiting?
Yes, NCT04850456 is actively recruiting participants. Contact the research team at 13788904150@163.com for enrollment information.
Where is the NCT04850456 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China.
Who is sponsoring the NCT04850456 clinical trial?
NCT04850456 is sponsored by Children's Hospital of Fudan University. The trial plans to enroll 200 participants.