An interventional study of Methylprednisolone and IVIG in Henoch-Schönlein Purpura, sponsored by Children's Hospital of Fudan University. Recruiting at 3 sites in China. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Children's Hospital of Fudan University · Not applicable, Interventional, and Treatment
IgA vasculitis is relatively common in children,especially in Asian countries. Abdominal manifestation could be severe, including bleeding, pancreatitis,appendicitis and intestinal intussusception. Delayed diagnosis could be fatal and cause severe complications.Nowadays no guidelines for those with severe abdominal manifestations in China.However, the most used treatment is steroid. For those severe forms are methylprednisolone pulse, IVIG, immunosuppressants and blood purification. Given the fact that different strategies lead to different endings which varies in cost, adverse effect and clinical outcomes in different medical centers, it is necessary to give birth to a useful and feasible strategy. This clinical trial is a muti-center, randomized,controlled prospective study.Patients with gastrointestinal disease will be recruited in three children's medical centres in Shanghai and will be randomized to two groups: MP group and IVIG group. Cost effect and clinical outcomes will be evaluated. Blood purification will be evaluated as a remedy when MP and IVIG fail to cure.
36 studies on the registry are indexed under IgA Vasculitis; 12 are open to participants now.
This study's planned enrollment of 150 is above the median of 60 across 19 interventional studies indexed under IgA Vasculitis.
Browse IgA Vasculitis studies →Children's Hospital of Fudan University is the lead sponsor of 268 studies on the registry; 95 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this group patients will be given Methylprednisolone pulse(15-30mg/kg/d) and continued with oral prednisolone (2mg/kg/d)
Drug: Methylprednisolone · Drug: other basic supportive treatment
In this group patients will be given IVIG (2g/kg) and at the same time oral prednisolone (2mg/kg/d)
Drug: IVIG · Drug: other basic supportive treatment
1.methylprednisolone pulse (15-30mg/kg/d) for 3 days with continued oral prednisolone(2mg/kg/d) 2.if the patients still complain abdominal pain and feel abdominal tenderness on the third day after intervention , patients would be given IVIG(2g/kg/d)as a change
1. IVIG 2g/kg and oral prednisolone 2mg/kg/d 2.if the patients still complain abdominal pain and feel abdominal tenderness on the third day after intervention , patients would be given methylprednisolone pulse (15-30mg/kg/d) for 3 days
1. Omeprazole 0.8mg/kg.d.The maximum dose is less than 40mg per day 2. Low molecular weight heparin calcium 50IU/kg.d
sustained abdominal pain relief
no abdominal pain complaint and no abdominal tenderness
Time frame: 3 days after treatment
sustained abdominal pain relief
3 days after treatment part of the patients may fail the first assigned intervention and has to accept the alternative intervention and abdominal pain complaint and abdominal tenderness will be checked at 7 days after treatment
Time frame: 7 days after treatment
other treatment rather than assigned intervention
other treatment such as blood purification, the second methylprednisolone pulse, and immunosuppressant will be documented if the two interventions all failed
Time frame: 4 weeks after treatment
tolarable food type
what kind of food can be tolerant ( 0 fluid, 1 semi liquid, 2 solid )
Time frame: 2 weeks after treatment
the number of days of taking fasting
the number of days of taking fasting will be counted at the time of discharge
Time frame: At the time of discharge
Drug-related side effects
Side effects associated with methylprednisolone and IVIG will be recorded
Time frame: 3 days after treatment
hypertension
systolic or diastolic blood pressure greater than or equal to 95% for the age, sex, and height of the patient is considered to have 1.hypertension otherwise 0. Blood pressure will be measured with mercury blood pressure monitor.
Time frame: 7 days after treatment
infection
different infection types should be specified
Time frame: 4 weeks after treatment
ocular hypertension
1.ocular hypertension 0. no ocular hypertension. Ocular hypertension will be defined as intraocular pressure of either eye is greater greater or equal to 21mmHg
Time frame: 7 days after treatment
steroid-related diabetes
1. with steroid-related diabetes 0. no steroid-related diabetes . Steroid-related diabetes will be defined as random blood sugar is greater than 11.1 mmol/l
Time frame: 3 days after treatment
cost of treatment
cost of treatment will be obtained from discharge fee list
Time frame: 4 weeks after treatment
The number of days in hospital
The number of days in hospital will be counted at the time of discharge
Time frame: at the time of discharge
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
No publications or documents are linked to this record.
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Studies of the drug tested here: Methylprednisolone
Children's Hospital of Fudan University →