Daily vs alternate-day plasma exchange in pediatric autoimmune encephalitis
Official title: Daily Versus Alternate-Day Plasma Exchange in Pediatric Autoimmune Encephalitis: A Randomized Controlled Trial
Run by Menoufia University · NCT07707739 · Data updated 2026-11-12
This study tests whether giving plasma exchange on consecutive days is better than every other day for kids with autoimmune encephalitis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Month to 18 Years |
| Sex | All |
| Enrollment | 22 (estimated) |
| Sponsor | Menoufia University Academic / other |
| Locations | 1 site (Shibīn al Kawm, Menoufia Governorate) |
| Status | Recruiting |
| Started | August 1, 2026 |
| Main results expected | February 28, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT07707739 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children diagnosed with autoimmune encephalitis for whom plasma exchange is clinically indicated.
✕Probably not a fit
Patients without a favorable response to plasma exchange or those with exclusion criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, randomized, open-label, parallel-group trial will enroll children with autoimmune encephalitis admitted to the PICU at Menoufia University Hospital. Participants will be randomized to receive 5–7 plasma exchange sessions either on consecutive days (Arm A) or every other day (Arm B). A blinded assessor will determine functional outcome using the modified Rankin Scale (mRS) at the end of the treatment sessions, with the goal of identifying which schedule yields a better functional recovery. Data collection will include demographics, treatment details, vital signs, clinical exams, and laboratory and imaging studies as clinically indicated. Safety monitoring will track immediate complications of plasma exchange and other adverse events.
Why it matters
Potential benefit: If successful, the study could define an optimal plasma exchange schedule to improve functional outcomes in pediatric autoimmune encephalitis.
How similar studies have gone: There is limited prior evidence in this specific pediatric, randomization-compare schedule context; this study addresses a novel comparison in this population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Childern diagnosed as autoimmune encephalitis according to Cellucci et al., 2020; acute/subacute onset (\<3 months) of encephalopathy with at least one of: new focal CNS findings, seizures, CSF pleocytosis, MRI suggestive of encephalitis, and supportive antibody testing when available. * Autoimmune encephalitis cases indicated clinically for PLEX as determined by the treating team (e.g., severe disease, refractory to steroids/IVIG or as part of first-line combination therapy). Exclusion Criteria: * Hemodynamic instability not amenable to plasma exchange. * Severe coagulopathy uncorrectable prior to PLEX (INR \>2 despite correction, platelets \<50,000/µL unless corrected). * Contraindications to central venous access placement. * Enrollment in another interventional trial that would interfere with the outcomes.
Where it's running
-
Menoufia university hospital, Pediatric intensive care unit
Shibīn al Kawm, Menoufia Governorate, Egypt Recruiting
Study contacts
- Principal investigator: Hani Hamed Saad, MD, lecturer of pediatrics — Faculty of medicine, Menoufia University
- Study coordinator: Hani Hamed Saad, MD, pediatrics
- Email: hani.hamed870@med.menofia.edu.eg
- Phone: +201067610619
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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.