Baseline cyst size guided increase in duration for steroid therapy in viable parenchymal neurocysticercosis a pilot prospective interventional study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- In children and adolescents aged 2-18 years with viable parenchymal NCC (up to 5 lesions), in cysts more than or equal to 0.7 cm, receiving Dexamethasone (0.6 mg/kg/day) for 14 days, to estimate the proportion of resolved cysts at 6 months (+ 1 month) on CECT Head post completion of albendazole and steroid therapy
Study Overview
Brief Summary
Patients will be enrolled from Pediatric OPD, Casualty or Ward based on inclusion criteria as enumerated.The baseline and 6 months CT will be interpreted at the Dept of Radiodiagnosis under the supervision of co-guide from the same. Clinically patients will be followed up at 2 and 4 weeks post initiation of treatment and then at 3 and 6 months post completion of therapy apart from whenever indicated otherwise.Telephonically they will be reviewed every week.BP and blood glucose monitoring once on 5th day of 5 days arm and 7th and 14th days of 14 days arm will be done.At least 30 cysts will be enrolled in the study as per sample size calculation and feasibility of the study in the population.Data will be entered in a pre-designed proforma and statistical analysis will be done as applicable.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 2.00 Year(s) to 18.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Children and adolescents aged 2-18 years 2.Parenchymal NCC, viable (vesicular/colloidal), up to 5 in number 3.In multiple lesions with sizes less than as well as more than 0.7 cm, it will be included in the 14 days steroid group and only the more than 0.7 cm cyst outcome will be analysed.
Exclusion Criteria
- •1.Received anticysticidal and steroid therapy in the last 6 months 2.Need for repeat steroid therapy within 6 months follow up 3.Raised ICP, cysticercal encephalitis 4.Extra-parenchymal NCC, intra-ocular NCC 5.Critically sick children Co-existing known chronic illness.
Outcomes
Primary Outcomes
In children and adolescents aged 2-18 years with viable parenchymal NCC (up to 5 lesions), in cysts more than or equal to 0.7 cm, receiving Dexamethasone (0.6 mg/kg/day) for 14 days, to estimate the proportion of resolved cysts at 6 months (+ 1 month) on CECT Head post completion of albendazole and steroid therapy
Time Frame: 6 months post therapy
Secondary Outcomes
- In children and adolescents aged 2-18 years with viable parenchymal NCC (up to 5 lesions), in cysts less than 0.7 cm receiving Dexamethasone (0.6 mg/kg/day) for 5 days, to estimate the proportion of resolved cysts at 6 months (+ 1 month) on CECT Head post completion of albendazole and steroid therapy(To estimate breakthrough seizure rates in both the groups over at least 6 months follow up post completion of albendazole and steroid therapy)
Investigators
Dr Priyabrata Samal
All India Institute of Medical Sciences, New Delhi