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Clinical Trials/CTRI/2024/04/066148
CTRI/2024/04/066148Not yet recruitingNot Applicable

To Study Incidence and clinical outcomes of neonatal meningitis in a Level III NICU – a ambispective observational study

Dr Sonali Amol Avale1 site in 1 country100 target enrollmentStarted: May 7, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
To study the incidence of neonatal meningitis

Study Overview

Brief Summary

Neonatal meningitis continues to be a serious health challenge with high mortality and morbidity worldwide . Neonatal meningitis is a diffuse inflammation of the meninges during the first 28 days of life . Despite advances in the management of neonatal meningitis, mortality and neurologic complications are still unacceptably high, especially in developing countries .The risk factors associated with neonatal meningitis in neonatal sepsis might vary from one study area to another .Previous studies found that neonatal meningitis was high in neonates with prematurity , maternal history of chorioamnionitis, Prolonged Rupture of Membrane (PROM) , perinatal asphyxia a , positive blood culture [5], and group B streptococcus bacteremia .In neonates, signs and symptoms of serious infections are often obscure, and the clinical presentation of neonatal meningitis is indistinguishable from that of neonatal sepsis without meningitis . The most important clinical indicators of neonatal meningitis are convulsions, irritability, bulging fontanel, and temperature ≥ 39°C . Therefore, the only confirmatory diagnosis for neonatal meningitis is cerebrospinal fluid analysis. Hence, the current study aimed to determine the magnitude and clinical presentations  of neonatal meningitis among newborns with neonatal sepsis.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
0.00 Day(s) to 30.00 Day(s) (—)
Sex
All

Inclusion Criteria

  • All neonates with positive biochemical parameters((as per the age wise cutoff) in CSF or culture positive meningitis in NICU, Government medical College and Hospital Aurangabad.

Exclusion Criteria

  • Neonates with negative CSF reports (Biochemical parameters).

Outcomes

Primary Outcomes

To study the incidence of neonatal meningitis

Time Frame: To study the incidence of neonatal meningitis

Secondary Outcomes

  • To study:(Mortality)

Investigators

Sponsor
Dr Sonali Amol Avale
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Sonali Amol Avale

Government Medical college , Sambhaji Nagar

Study Sites (1)

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