Non Traumatic Chronic Subdural Haematoma in Paediatric Age Groups, Management and Outcome

December 17, 2024 updated by: abo bakr mitwally, Assiut University
1-Review the management strategies and outcomes in cases of non traumatic chronic subdural haematoma in paediatric age group. 2- Review the underlying causes and risk factors in cases of non traumatic chronic subdural haematoma in paediatric age group

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

2.4.1- Type of the study: prospective case series study 2.4. 2- Study Setting: Neurosurgery department Assiut university hospital 2.4. 3- Study subjects:

  1. Inclusion criteria:

    1-Age less than 18 years. 2-patient with subdural haematoma other than traumatic

  2. Exclusion criteria:

    1-Age more than 18 years. 2-patient with traumatic subdural haematoma. 3- patient unfit for surgery

    Patient and method:

    1-General examination. 2- Neurological examination. 3- complete basal investigations. 4-Imaging brain CT scan In paediatric patients with subdural hematoma with an amount of bleeding requiring surgical management, any underlying comorbidities should be investigated regardless of the presence of a history of trauma. While investigating systemic diseases, special attention should be paid to the presence of arachnoid cysts or disruption in cerebrospinal fluid dynamics along with a history of hematologic diseases Data on patient sex, age, bleeding location, type of hematoma based on computed tomography imaging, surgical treatment, presenting symptoms, presence of comorbidities, Glasgow Coma Scale, platelets counts, and international normalized ratio values were recorded There will be file to collect data ( patient data sheet)of the patient: involving personal data and detailed history and detailed general and neurological examinations and all general investigations and specific according to her underlying medical disorders ( risk factor and cause of non traumatic subdural haematoma) and type of treatment that received and report of ct scan and mri Symptoms of subdural haematoma: Drowsy/unconscious , Poor feeding , Irritability , Fits , Pallor , Floppiness , Vomiting , Sudden collapse, Breathing difficulties , Large head , Apnoea , Delayed development Neurological assessment plus Glasgow Coma Scale(paediatric GCS and pupillary reactivity) Investigations: CT scan brain MRI BRAIN : cranial subdural haematoma site and location , size in cm, detected midline shift ,uni or bilateral subdural haematoma, haematoma density , haematoma thickness plus other cranial bleeding or pathology or other spinal cord bleeding or pathology All blood investigations including cbc , coagulation profile , liver ,renal functions , all investigations related to underlying medical or neurological or neurosurgical disorder.

    Treatment: admission either in intensive care unit ,or in the department and type of treatment either medical with conservative involving dexamethasone plus or minus atrovostatins(2.5-5 mg atorvastatin daily combined with dexamethasone with stepwise-decreasing dosing for a total of 4 weeks) Or surgical in the form of burr hole trepanation (Burr-hole drainage (BHD), craniectomy and craniotomy After treatment follow up for 2 days , one month and three months post operative.

  3. Sample Size Calculation: 30 cases according previous case series studies in these rare disease and according to sample size calculation.

2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):CT scan brain MRI BRAIN detected site and location of cranial subdural haematoma ,midline shift uni or bilateral subdural haematoma, haematoma density , haematoma thickness plus other cranial bleeding or pathology or other spinal cord bleeding or pathology All blood investigations including cbc , coagulation profile , liver ,renal functions , all investigations related to underlying medical or neurological or neurosurgical disorder There will be file to collect data ( patient data sheet)of the patient involving personal data and detailed history and detailed general and neurological examinations and all general investigations and specific according to her underlying medical disorders ( risk factor and cause of non traumatic cranial subdural haematoma) and type of treatment that received and report of ct scan and mri

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

pediatric age group from first hour after birth of newborn till 18 years old

Description

Inclusion Criteria:1-Age less than 18 years. 2-patient with subdural haematoma other than traumatic -

Exclusion Criteria:1-Age more than 18 years. 2-patient with traumatic subdural haematoma. 3- patient unfit for surgery

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnosis and outcome of different types of treatment of non traumatic chronic subdural haematoma in paediatric age group in within one year.
Time Frame: one year
diagnosis and outcome of different types of treatment of non traumatic chronic subdural haematoma in paediatric age group.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary (subsidiary): the underlying risk factors and possible relation to non traumatic chronic subdural haematoma in paediatric age group and how to decrease its recurrence
Time Frame: one year
Secondary (subsidiary): the underlying risk factors and possible relation to non traumatic chronic subdural haematoma in paediatric age group and how to decrease its recurrence
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 15, 2024

Primary Completion (Estimated)

December 15, 2025

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 17, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTCSDH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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