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AzTrials

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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

  1. 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.

  1. First posted6 Jan 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

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)
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

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.

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