MeningitisNCT07320599
Neuroendoscopic Surgery With Ommaya Reservoir Implantation vs. Burr Hole Drainage for Infantile Postmeningitis Subdural Lesions: Superior Efficacy, Critical Impact of Surgical Timing, and Pathogenic Bacteria as Risk Factors for Progression
An observational study of Meningitis, run by Shengjing Hospital.
Trial summary
Globally, approximately 750,000 cases of infantile meningitis occur annually[1]. Clinical data show infantile postmeningitis subdural fluid collection (IPSFC) is the most common complication of infantile bacterial meningitis (IBM), with a progression rate of 30-60% (39% in standardized treatment cohorts)[2]. Read more about this study
- Who is it for?
- Ages 1 month to 1 year
- Conditions the study is for
- Meningitis
- What is being tested?
- Endoscopic Subdural Fluid Collection Evacuation & Ommaya Reservoir Implantation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Children undergoing surgical treatment should meet at least one imaging criterion (persistent short-term widening of the subdural space or compression of lateral ventricles; unilateral fluid collection thickness >1 cm for two consecutive weeks; formation of empyema abscess wall or mature empyema) and at least two clinical criteria (head circumference growth rate exceeding normal range or increased fontanelle tension; worsening IPSSL symptoms or persistent poor infection control; manifestations of intracranial hypertension such as repeated vomiting or lethargy; frequent neurological abnormalities like epileptic seizures; asymptomatic cases with fluid/empyema thickness >1 cm for >2 weeks).
Who may be able to join
- All enrolled children had received ≥3 weeks of standardized anti-infection therapy, including empirical or susceptibility-guided antibiotics administered intrathecal (post-lumbar puncture) or intravenous and dexamethasone administered intrathecal or intravenous. During conservative management, vital/neurological signs were closely monitored, with regular imaging to assess fluid thickness and empyema progression. Cranial ultrasound (primary modality, ≤3-day intervals) was performed, while CT/MRI were conducted ≤weekly.
Who cannot join
- subdural fluid collections secondary to viral meningitis; secondary collections with confirmed craniocerebral trauma history; diagnosed tuberculous subdural fluid collection; intracranial space-occupying lesions.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Globally, approximately 750,000 cases of infantile meningitis occur annually[1]. Clinical data show infantile postmeningitis subdural fluid collection (IPSFC) is the most common complication of infantile bacterial meningitis (IBM), with a progression rate of 30-60% (39% in standardized treatment cohorts)[2]. Pathogens, predominantly Escherichia coli and Streptococcus pneumoniae, account for 70% of IPSFC cases[3]. IPSFC progresses to subdural empyema (IPSE) in 3.7-17.6% of cases, with 87.1% of IPSE cases occurring in infants <1 year old[4]. Collectively termed infantile postmeningitis subdural space lesions (IPSSL), these conditions impose the highest burden in Sub-Saharan Africa's "Meningitis Belt" and Southeast Asia[5]. IPSE progresses rapidly in infants, with a mortality rate of 18% and 50% of survivors developing neurological sequelae (e.g., epilepsy, motor/intellectual disability, sensory impairment)[6]. While spontaneously resolved IPSFC shows no significant sequelae, prolonged IPSE disrupts brain development, requires extended treatment, and incurs substantial familial burdens.
Causes of IPSFC secondary to IBM include increased subdural capillary permeability (with plasma exudation), cerebrospinal fluid (CSF) circulation/absorption disturbance, immature infantile blood-brain barrier (BBB), and underdeveloped arachnoid granulations[7]. IPSFC typically develops on days 7-10 of IBM and is staged by fluid thickness: Stage I (<0.3 mm), Stage II (3-8 mm), Stage III (>8 mm)[8]. Uncontrolled IBM infection, due to inappropriate antibiotics, inadequate dosage, delayed treatment, or infantile immunocompromise, e.g., preterm infants, allows pathogens to invade and proliferate in the subdural space, inducing local secondary infection, inflammatory cell infiltration, and accumulation of pathogen metabolites/necrotic tissue-ultimately progressing to IPSE[9]. Fibrinogen exudation and fibroblast activation may further form subdural fibrous cords, septa, purulent plaques, inflammatory pseudomembranes, and other fibro-inflammatory proliferative lesions (FIPLs)[10]. IPSE causes more severe mass/toxic effects, requiring aggressive surgical intervention. Cranial MRI shows empyema cavity rim enhancement, heterogeneous internal signals due to fluid collection septa, and dural thickening.
Read more
The progression rate of IPSFC to IPSE ranges from 3.7% to 17.6%, influenced by IBM pathogen types, therapeutic intervention, and host immunity[11]. However, large-scale cohort studies on risk factors for this progression remain lacking. Early adequate antibiotic therapy reduces IPSFC incidence by nearly 50%, whereas delayed intervention may accelerate IPSFC onset (day 3-7) via unremitting meningeal permeability[12]. Inadequate antibiotic courses may promote persistent IPSFC progression with FIPLs formation. Some pediatric neurosurgeons advocate extending antibiotic therapy beyond 21 days for IPSFC to prevent progression to IPSE[13].
Despite early antibiotic therapy reducing IBM mortality, IPSSL management remains challenging. A clinical study showed 22.4% of IPSFC cases required surgery, but occult inflammation in infants can prolong IPSFC up to 2 months[14]. Infantile unclosed fontanelles and cranial elasticity increase neurosurgical complication risks. Current consensus suggests asymptomatic/small-volume fluid collections (thickness <5 mm) often resolve spontaneously, obviating intervention[15]. Ultrasound-guided subdural puncture (US-SP-AF) is the first-line invasive treatment, curing about 50% of infants acutely but with a 30-50% recurrence rate. Whether US-SP-AF reduces IPSFC-to-IPSE progression remains controversial. For US-SP-AF-resistant cases, minimally invasive burr hole irrigation (BHID) with silicone tube drainage (3-5 days) is used; BHID shows higher cure rates than US-SP-AF but still has a 20-33% recurrence rate in small cohorts[16].
Neuroendoscopic technique allows rigid endoscope entry into the subdural space for visualized resection of pathological tissues, management of multiloculated cavities, adhesion lysis, and FIPLs irrigation. This approach directly targets the pathological substrate under vision, reducing residual lesions and recurrence rates compared to traditional methods. In adult cohorts, 6-month postoperative fluid collection recurrence rates are only 8% with neuroendoscopy, versus 33% with BHID[17]. However, neuroendoscopic exploration is technically demanding and equipment-dependent. The Ommaya reservoir offers advantages in postoperative management of cerebrospinal fluid-related disorders, including precise drainage, dynamic monitoring of disease progression, and local drug administration. However, it may be prone to catheter obstruction by pathological components[18].
Severe IPSSL causes intracranial hypertension and neurodevelopmental impairment, requiring comprehensive pediatric neurosurgical and pharmacologic strategies. Treatment selection depends on IPSFC/IPSE pathological features. Current stu
- Conditions
- Meningitis
- Being tested
- Endoscopic Subdural Fluid Collection Evacuation & Ommaya Reservoir Implantation
- Keywords
- infantile meningitis
- Medical subject headings
- Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Subdural Fluid Collection Evacuation & Ommaya Reservoir ImplantationProcedure or surgery
Neuroendoscopy offers significant advantages in IPSE/IPSFC management. It enables visualized resection of subdural FIPLs (fibrous cords, purulent debris, septa, most pseudomembranes), improving lesion clearance and reducing pathogen colonization via high-definition visualization. The minimally invasive approach uses a 3-cm incision and 4-6 cm² bone window, minimizing iatrogenic injury to brain and dura. Meanwhile, direct visualization allows exploration of multilocular cavities, septum disruption, and complete drainage, avoiding residual risks of traditional single-burr drainage. Visualized manipulation avoids vessels and functional areas, reducing injury and complications (e.g., epilepsy, deficits), and protecting infant brain development. ORI is crucial in IPSE/IPSFC treatment.
What is being measured
The primary outcome is the main question the study is designed to answer.
IPSSL-score
This scale incorporates the Hines Neurological Score for Infants (neonatal to 2-year neurofunctional assessment, adapted from traditional Hines Score), intracranial pressure parameters, inflammatory control, and neurological function. The IPSSL-score (total 20 points) shows lower preoperative scores indicate worse symptoms and higher postoperative scores reflect better outcomes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MeningitisStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wangyikang, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320599
- Sponsor's protocol ID
- wangyikang@000622
- Status last verified
- Dec 2025
- First submitted
- 5 Sep 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen TM, Chen HY, Hu B, Hu HL, Guo X, Guo LY, Li SY, Liu G. Characteristics of Pediatric Recurrent Bacterial Meningitis in Beijing Children's Hospital, 2006-2019. J Pediatric Infect Dis Soc. 2021 May 28;10(5):635-640. doi: 10.1093/jpids/piaa176.
PubMed 33491083
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroendoscopic Surgery With Ommaya Reservoir Implantation vs. Burr Hole Drainage for Infantile Postmeningitis Subdural Lesions: Superior Efficacy, Critical Impact of Surgical Timing, and Pathogenic Bacteria as Risk Factors for Progression
- ClinicalTrials.gov ID
- NCT07320599
- Acronym / sponsor ID
- wangyikang@000622
- Conditions
- Meningitis
- Keywords
- infantile meningitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Globally, approximately 750,000 cases of infantile meningitis occur annually[1]. Clinical data show infantile postmeningitis subdural fluid collection (IPSFC) is the most common complication of infantile bacterial meningitis (IBM), with a progression rate of 30-60% (39% in standardized treatment cohorts)[2]. Pathogens, predominantly Escherichia coli and Streptococcus pneumoniae, account for 70% of IPSFC cases[3]. IPSFC progresses to subdural empyema (IPSE) in 3.7-17.6% of cases, with 87.1% of IPSE cases occurring in infants <1 year old[4]. Collectively termed infantile postmeningitis subdural space lesions (IPSSL), these conditions impose the highest burden in Sub-Saharan Africa's "Meningitis Belt" and Southeast Asia[5]. IPSE progresses rapidly in infants, with a mortality rate of 18% and 50% of survivors developing neurological sequelae (e.g., epilepsy, motor/intellectual disability, sensory impairment)[6]. While spontaneously resolved IPSFC shows no significant sequelae, prolonged IPSE disrupts brain development, requires extended treatment, and incurs substantial familial burdens.
Causes of IPSFC secondary to IBM include increased subdural capillary permeability (with plasma exudation), cerebrospinal fluid (CSF) circulation/absorption disturbance, immature infantile blood-brain barrier (BBB), and underdeveloped arachnoid granulations[7]. IPSFC typically develops on days 7-10 of IBM and is staged by fluid thickness: Stage I (<0.3 mm), Stage II (3-8 mm), Stage III (>8 mm)[8]. Uncontrolled IBM infection, due to inappropriate antibiotics, inadequate dosage, delayed treatment, or infantile immunocompromise, e.g., preterm infants, allows pathogens to invade and proliferate in the subdural space, inducing local secondary infection, inflammatory cell infiltration, and accumulation of pathogen metabolites/necrotic tissue-ultimately progressing to IPSE[9]. Fibrinogen exudation and fibroblast activation may further form subdural fibrous cords, septa, purulent plaques, inflammatory pseudomembranes, and other fibro-inflammatory proliferative lesions (FIPLs)[10]. IPSE causes more severe mass/toxic effects, requiring aggressive surgical intervention. Cranial MRI shows empyema cavity rim enhancement, heterogeneous internal signals due to fluid collection septa, and dural thickening.
The progression rate of IPSFC to IPSE ranges from 3.7% to 17.6%, influenced by IBM pathogen types, therapeutic intervention, and host immunity[11]. However, large-scale cohort studies on risk factors for this progression remain lacking. Early adequate antibiotic therapy reduces IPSFC incidence by nearly 50%, whereas delayed intervention may accelerate IPSFC onset (day 3-7) via unremitting meningeal permeability[12]. Inadequate antibiotic courses may promote persistent IPSFC progression with FIPLs formation. Some pediatric neurosurgeons advocate extending antibiotic therapy beyond 21 days for IPSFC to prevent progression to IPSE[13].
Despite early antibiotic therapy reducing IBM mortality, IPSSL management remains challenging. A clinical study showed 22.4% of IPSFC cases required surgery, but occult inflammation in infants can prolong IPSFC up to 2 months[14]. Infantile unclosed fontanelles and cranial elasticity increase neurosurgical complication risks. Current consensus suggests asymptomatic/small-volume fluid collections (thickness <5 mm) often resolve spontaneously, obviating intervention[15]. Ultrasound-guided subdural puncture (US-SP-AF) is the first-line invasive treatment, curing about 50% of infants acutely but with a 30-50% recurrence rate. Whether US-SP-AF reduces IPSFC-to-IPSE progression remains controversial. For US-SP-AF-resistant cases, minimally invasive burr hole irrigation (BHID) with silicone tube drainage (3-5 days) is used; BHID shows higher cure rates than US-SP-AF but still has a 20-33% recurrence rate in small cohorts[16].
Neuroendoscopic technique allows rigid endoscope entry into the subdural space for visualized resection of pathological tissues, management of multiloculated cavities, adhesion lysis, and FIPLs irrigation. This approach directly targets the pathological substrate under vision, reducing residual lesions and recurrence rates compared to traditional methods. In adult cohorts, 6-month postoperative fluid collection recurrence rates are only 8% with neuroendoscopy, versus 33% with BHID[17]. However, neuroendoscopic exploration is technically demanding and equipment-dependent. The Ommaya reservoir offers advantages in postoperative management of cerebrospinal fluid-related disorders, including precise drainage, dynamic monitoring of disease progression, and local drug administration. However, it may be prone to catheter obstruction by pathological components[18].
Severe IPSSL causes intracranial hypertension and neurodevelopmental impairment, requiring comprehensive pediatric neurosurgical and pharmacologic strategies. Treatment selection depends on IPSFC/IPSE pathological features. Current stu
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children undergoing surgical treatment should meet at least one imaging criterion (persistent short-term widening of the subdural space or compression of lateral ventricles; unilateral fluid collection thickness >1 cm for two consecutive weeks; formation of empyema abscess wall or mature empyema) and at least two clinical criteria (head circumference growth rate exceeding normal range or increased fontanelle tension; worsening IPSSL symptoms or persistent poor infection control; manifestations of intracranial hypertension such as repeated vomiting or lethargy; frequent neurological abnormalities like epileptic seizures; asymptomatic cases with fluid/empyema thickness >1 cm for >2 weeks).
Key inclusion criteria (1 listed)
- All enrolled children had received ≥3 weeks of standardized anti-infection therapy, including empirical or susceptibility-guided antibiotics administered intrathecal (post-lumbar puncture) or intravenous and dexamethasone administered intrathecal or intravenous. During conservative management, vital/neurological signs were closely monitored, with regular imaging to assess fluid thickness and empyema progression. Cranial ultrasound (primary modality, ≤3-day intervals) was performed, while CT/MRI were conducted ≤weekly.
Key exclusion criteria (1 listed)
- subdural fluid collections secondary to viral meningitis; secondary collections with confirmed craniocerebral trauma history; diagnosed tuberculous subdural fluid collection; intracranial space-occupying lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Subdural Fluid Collection Evacuation & Ommaya Reservoir ImplantationNeuroendoscopy offers significant advantages in IPSE/IPSFC management. It enables visualized resection of subdural FIPLs (fibrous cords, purulent debris, septa, most pseudomembranes), improving lesion clearance and reducing pathogen colonization via high-definition visualization. The minimally invasive approach uses a 3-cm incision and 4-6 cm² bone window, minimizing iatrogenic injury to brain and dura. Meanwhile, direct visualization allows exploration of multilocular cavities, septum disruption, and complete drainage, avoiding residual risks of traditional single-burr drainage. Visualized manipulation avoids vessels and functional areas, reducing injury and complications (e.g., epilepsy, deficits), and protecting infant brain development. ORI is crucial in IPSE/IPSFC treatment. | Procedure or surgery | – |
Primary outcome
IPSSL-score
Time frame: 1 year
This scale incorporates the Hines Neurological Score for Infants (neonatal to 2-year neurofunctional assessment, adapted from traditional Hines Score), intracranial pressure parameters, inflammatory control, and neurological function. The IPSSL-score (total 20 points) shows lower preoperative scores indicate worse symptoms and higher postoperative scores reflect better outcomes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Results publication: PubMed 33491083Chen TM, Chen HY, Hu B, Hu HL, Guo X, Guo LY, Li SY, Liu G. Characteristics of Pediatric Recurrent Bacterial Meningitis in Beijing Children's Hospital, 2006-2019. J Pediatric Infect Dis Soc. 2021 May 28;10(5):635-640. doi: 10.1093/jpids/piaa176.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningitis, run by Shengjing Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact wangyikang Dr (+8613775970207, kangyiwang2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPSSL-score (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07320599, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.