| 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
|
|
|
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
|
|
|
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 |