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A clinical study to compare two techniques of CSF culture to diagnose neonatal meningitis

A STUDY OF COMPARISON BETWEEN TWO METHODS OF CSF CULTURE IN NEONATES WITH NEONATAL SEPSIS (BACS)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2008/091/000209
Enrollment
Unknown
Registered
2008-10-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: NOT APPLICABLE: NOT APPLICABLE Control Intervention1: NOT APPLICABLE: NOT APPLICABLE

Sponsors

Dr. Satish Saluja, Senior Consultant, Department of Neonatology, Sir Ganga Ram Hospital, New Delhi
Lead Sponsor
Dr. Chand Wattal, Senior Consultant, Department of Microbiology, Sir Ganga Ram Hospital, New Delhi
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Neonates admitted to NICU and undergoing CSF examination for suspect sepsis after taking Parental informed consent

Exclusion criteria

Exclusion criteria: Less than 1 ml of CSF obtained for culture Babies having any contraindication of doing CSF Major congenital anomalies Grossly traumatic CSF Dry tap Neonates in whom consent is not available

Design outcomes

Primary

MeasureTime frame
CSF culture positivityTimepoint: seven days from the time of inoculation of CSF

Secondary

MeasureTime frame
Association between sepsis screen parameters and CSF culture positivity Association between blood and CSF culture positivity Association between cytology and CSF culture positivity To compare the time to positivity of culture between two methods Complications of meningitis Seizures Neurological deficits Abnormal neurological examination Post meningitic hydrocephalous Abnormalities on neuroimaging Timepoint: During hospital stay

Countries

India

Contacts

Public ContactAnil Batra

Sir Ganga Ram Hospital, New Delhi

drbatra77@gmail.com01142251738

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026