| CTRI Number |
CTRI/2024/12/078760 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
CLINICAL PROFILE OF NEONATES
WITH SEPSIS |
|
Scientific Title of Study
|
Clinical profile of neonates admitted in NICU with sepsis : A cross sectional 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 ACHYUT RAMESH PATEL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
| Address |
Neonatal Intensive Care Unit,Department of Paediatrics, Rohilkhand Medical College, Pilibhit Bypass Road, Bareilly 243006
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
09920567447 |
| Fax |
|
| Email |
achyutrameshpatel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHIVANI BANSAL |
| Designation |
ASSOCIATE PROFFESSOR |
| Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room No. 3012, Department of Paediatrics, Rohilkhand Medical College, Pilibhit Bypass Road, Bareilly 243006
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
8958253869 |
| Fax |
|
| Email |
achyutrameshpatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ACHYUT RAMESH PATEL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room No. 3012, Department of Paediatrics, Rohilkhand Medical College, Pilibhit Bypass Road, Bareilly 243006
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
09920567447 |
| Fax |
|
| Email |
achyutrameshpatel@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF PEDIATRICS, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, PILIBHIT BYPASS ROAD, BAREILLY. |
|
|
Primary Sponsor
|
| Name |
DR ACHYUT RAMESH PATEL |
| Address |
Department of Paediatrics, Rohilkhand Medical College, Pilibhit Bypass Road, Bareilly 243006 |
| Type of Sponsor |
Other [] |
|
|
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 ACHYUT RAMESH PATEL |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL PILIBHIT BYPASS ROAD BAREILLY
Bareilly
UTTAR PRADESH |
9920567447
achyutrameshpatel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, RMCH, BAREILLY, UP |
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 |
1.00 Day(s) |
| Age To |
10.00 Day(s) |
| Gender |
Both |
| Details |
All neonates with symptoms and clinical signs suggestive of sepsis, with or without maternal and/or neonatal risk factors.
Attendants of the neonates who gave informed consent.
|
|
| ExclusionCriteria |
| Details |
Attendants of the neonates who did not give informed consent.
Neonates with apparent congenital anomalies.
Outborn neonates admitted to the NICU with a prior history of antibiotic treatment in the last 48 hours.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
â— To study the clinical profile in neonate with sepsis
OBJECTIVES
â— To identify causative organisms and study their antibiotic sensitivity pattern
â— To assess the correlation of perinatal and maternal risk factors in causation and outcome of neonatal sepsis
|
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of hospital stay. |
At discharge |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
10/01/2025 |
| 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
|
Parents
of all the neonates were invited to participate in the study. The study
population consisted of all neonates admitted with a history and clinical
features suggestive of neonatal sepsis, and attendants who gave consent to
participate were enrolled in the study. For all the patients who gave
consent to participate and met the inclusion criteria, a detailed maternal
medical and obstetric history was obtained. Information regarding gestation,
including complications during pregnancy, gestational age at delivery, mode of
delivery, and birth weight, was recorded. A detailed history of the neonates
suggestive of neonatal sepsis was taken. A comprehensive general and systemic
examination of the neonates was performed, and neonatal risk factors were
identified.
Sepsis screen investigations were conducted, which
included:
Complete Blood Count (CBC), Micro ESR, C-reactive
protein (CRP), Blood culture and antibiotic sensitivity, Immature/Total
neutrophil ratio, Urine culture sensitivity, CSF culture and sensitivity (for
suspected cases of meningitis), Absolute neutrophil count
These investigations were used to identify indicators
suggestive of neonatal sepsis. |