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CTRI Number  CTRI/2024/04/064987 [Registered on: 01/04/2024] Trial Registered Prospectively
Last Modified On: 28/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Factors leading to infection among newborns. 
Scientific Title of Study   Case Control Study to Identify determinants of Neonatal Sepsis among admitted term and preterm newborns at KNH Shimla. 
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 Mohd Asif Qureshi 
Designation  Junior Resident 
Affiliation  IGMC, Shimla 
Address  Junior Resident, Dept of Pediatrics, 4th floor, Indira Gandhi Medical College, Shimla, HP - 171001

Shimla
HIMACHAL PRADESH
171001
India 
Phone  9024775518  
Fax    
Email  drasifquresh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mangla Sood 
Designation  Professor 
Affiliation  IGMC, Shimla 
Address  Professor, Dept of Pediatrics, Indira Gandhi Medical College, Ridge - Sanjauli Road, Lakkar Bazar, Shimla, HP - 171001

Shimla
HIMACHAL PRADESH
171001
India 
Phone  9418453465  
Fax    
Email  drmanglasood@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohd Asif Qureshi 
Designation  Junior Resident 
Affiliation  IGMC, Shimla 
Address  Junior Resident, Dept of Pediatrics, 4th floor, Indira Gandhi Medical College, Shimla, HP - 171001

Shimla
HIMACHAL PRADESH
171001
India 
Phone  9024775518  
Fax    
Email  drasifquresh@gmail.com  
 
Source of Monetary or Material Support  
Kamla Nehru Hospital and IGMC Shimla 
 
Primary Sponsor  
Name  KNH & IGMC 
Address  Shimla, HP - 171001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mohd Asif Qureshi  Indira Gandhi Medical College  Dept of Pediatrics, 4th floor, IGMC, Shimla
Shimla
HIMACHAL PRADESH 
9024775518

drasifquresh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indira Gandhi Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P369||Bacterial sepsis of newborn, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Neonates diagnosed with sepsis according to established clinical and haematological criteria of IMNCI and/or evidence of positive blood or CSF or urine culture results will be included as cases in this study.
Neonates who will not be suspected or diagnosed for neonatal sepsis and admitted to the neonatal unit of KNH due to other indication such as LBW, NNJ, asymtomatic prematurity, for feed progression during the study period will be included as controls. 
 
ExclusionCriteria 
Details  Neonates born outside KNH will be excluded from the study.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assess the risk factors of neonatal sepsis among SNCU admissions at KNH Shimla  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Profile of organism in newborn sepsis among SNCU admissions at KNH Shimla  1 year 
Antimicrobial resistance in newborn sepsis SNCU admissions at KNH Shimla  1 year 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
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)   10/04/2024 
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 Yet Recruiting 
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 sepsis is a significant public health concern in the lower and middle-income countriesof sub-Saharan Africa and South-East Asia. Consequently, despite a decreasing trend in global under-5 mortality and neonatal mortality during the last two decades, the rate of reduction of sepsis-specific mortality has been much slower compared to that of other causes like premature birth or intrapartum complications in these regions. More than six million neonates suffer from severe infections and sepsis annually in these regions, contributing to almost one-quarter of global neonatal deaths per year. 
India has the highest incidence of clinical sepsis (17,000/ 1,00,000 live births), [3] with case fatality rate of sepsis among neonates ranges between 25% to 65%.
There are epidemiological differences in the incidence, risk factors, pattern, and antimicrobial sensitivities of pathogens and mortality of neonatal sepsis among different regions and countries in the world. Specific strategies suitable for specific countries to prevent and treat neonatal sepsis are needed to accelerate the progress in preventing neonatal morbidity and mortality. Identification of risk factors and early diagnosis and institution of therapy according to local epidemiology and antimicrobial resistance pattern can improve neonatal survival.
Evidence from reviews of risk factors has been utilized globally to guide the development of management guidelines for neonatal sepsis, and it is similarly recommended that such evidence be used for guideline development for management decisions in India.
There is a lack of evidence on risk factors and common causative agents with their sensitivity patterns of neonatal sepsis in Himachal Pradesh.The present study, therefore, aims to determine the risk factors and etiology of neonatal sepsis with identification of antibiotic resistance pattern among the neonates delivered in a tertiary care teaching hospital in north India
 
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