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A randomized controlled trial for immune-modulating therapy and plasma exchange in the treatment of acute necrotizing encephalopathy of children

A randomized controlled trial for immune-modulating therapy and plasma exchange in the treatment of acute necrotizing encephalopathy of children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900028416
Enrollment
Unknown
Registered
2019-12-21
Start date
2019-12-20
Completion date
Unknown
Last updated
2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute necrotizing encephalopathy

Interventions

Group 1:Plasma exchange + high doses of methylprednisolone + immunoglobulin
Group 2:high doses of methylprednisolone + immunoglobulin

Sponsors

The PICU of Beijing Children's Hospital affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Aged 1 month to 18 year old; 2. Admitted to hospital within 24h; 3. Conform to the diagnostic criteria of acute necrotizing encephalopathy.

Exclusion criteria

Exclusion criteria: 1. Glasgow score 2T; 2. Children with severe hypersensitivity to one of the three components of methylprednisolone, immunoglobulin and plasma; 3. Children with essential hypertension, primary immunodeficiency, genetic metabolic disease and other basal diseases; 4. Within 24 hours after admission, children with acute necrotizing encephalopathy whose parents request to give up treatment or transfer to other hospital due to various reasons such as economy and prognosis (Children dying from disease are not included); 5. Parents do not agree to use high doses of methylprednisolone, immunoglobulin, and plasmapheresis for any one or more treatment.

Design outcomes

Primary

MeasureTime frame
Discharge fatality rate;length of stay in PICU;Invasive mechanical ventilation time;length of stay;Neurological sequelae;

Countries

China

Contacts

Public ContactQian Suyun

Beijing Children's Hospital affiliated to Capital Medical University

syqian1211@163.com+86 13370115029

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026