| CTRI Number |
CTRI/2024/04/066148 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Ambispective Study |
| Study Design |
Other |
|
Public Title of Study
|
To study rate of neonatal meningitis in our NICU |
|
Scientific Title of Study
|
To Study Incidence and clinical outcomes of neonatal meningitis in a Level III NICU – a ambispective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonali Amol Avale |
| Designation |
Senior Resident |
| Affiliation |
Government Medical college , Sambhaji Nagar |
| Address |
Department of Neonatology , Government Medical college , Sambhaji Nagar
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9850584999 |
| Fax |
|
| Email |
sonaliawale1193@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxmikant Deshmukh |
| Designation |
Head of Department of Neonatology |
| Affiliation |
Government Medical college , Sambhaji Nagar |
| Address |
Department of Neonatology , Government Medical college , Sambhaji Nagar
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9822478275 |
| Fax |
|
| Email |
deshmukhls@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Amol Avale |
| Designation |
Head of Department of Neonatology |
| Affiliation |
Government Medical college , Sambhaji Nagar |
| Address |
Department of Neonatology Government Medical college , Sambhaji Nagar
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9822478275 |
| Fax |
|
| Email |
deshmukhls@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Medical college , Sambhaji Nagar
|
|
|
Primary Sponsor
|
| Name |
Dr Sonali Amol Avale |
| Address |
Government Medical college , Sambhaji Nagar
|
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SONALI AMOL AVALE |
DEPARTMENT OF NEONATOLOGY , GOVERNMENT MEDICAL COLLEGE , AURANGABAD |
DEPARTMENT OF NEONATOLOGY , GOVERNMENT MEDICAL COLLEGE , AURANGABAD
Aurangabad
MAHARASHTRA |
9850584999
sonaliawale1193@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVT. MEDICAL COLLEGE AURANGABAD -431001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00||Bacterial meningitis, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
Neonates with negative CSF reports (Biochemical parameters) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the incidence of neonatal meningitis |
To study the incidence of neonatal meningitis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study:
Mortality
Duration of hospital stay
Other Complications during stay |
Discharge
Death |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |