| CTRI Number |
CTRI/2025/03/082587 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
comparision of parameters in complete blood count with sepsis screen and blood culture in neonatal sepsis |
|
Scientific Title of Study
|
Correlation of neutrophil to leukocyte ratio(NLR) and mean platelet volume (MPV) with sepsis screen and blood culture in neonatal sepsis - A prospective 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 Mouna S |
| Designation |
Postgraduate |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
Postgraduate in Department of Pediatrics, BGSGIMS, Bengaluru, Karnataka- 560060
Bangalore
KARNATAKA
560060
India |
| Phone |
8618097370 |
| Fax |
|
| Email |
mounas1197@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagajyothi S |
| Designation |
Associate Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
Associate Professor, Department of Pediatrics, BGSGIMS, Bengaluru, Karnataka- 560060
Bangalore
KARNATAKA
560060
India |
| Phone |
8867779137 |
| Fax |
|
| Email |
rashdaksh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nagajyothi S |
| Designation |
Associate Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
Associate Professor, Department of Pediatrics, BGSGIMS, Bengaluru, Karnataka- 560060
Bangalore
KARNATAKA
560060
India |
| Phone |
8867779137 |
| Fax |
|
| Email |
rashdaksh@gmail.com |
|
|
Source of Monetary or Material Support
|
| BGS Global Institute of Medical Sciences, Bengaluru, Karnataka, India- 560060 |
|
|
Primary Sponsor
|
| Name |
Dr Mouna S |
| Address |
Postgraduate in Department of Pediatrics, BGSGIMS, Bengaluru, Karnataka- 560060 |
| Type of Sponsor |
Other [self] |
|
|
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 Mouna S |
BGS Global Institute of Medical Sciences |
NICU #1,Department of Pediatrics,4th floor, BGSGIMS, Bengaluru, Karnataka- 560060
Bangalore
KARNATAKA |
8618097370
mounas1197@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BGS Global institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D759||Disease of blood and blood-formingorgans, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Both inborn and outborn neonates who are admitted to BGSGIMS NICU ,with either of,
1.more than 34 weeks of gestation with antenatal 2.risk factors for sepsis
3.PROM more than 18hrs
4.Prepartum fever
5.Chorioamnionitis
6.With clinical features of sepsis :
7.Hypothermia or fever with temperature instability
Lethargy, refusal of feeds
Hypotonia
Bradycardia or tachycardia
Respiratory distress
Hypotension or shock |
|
| ExclusionCriteria |
| Details |
1. Neonates with congenital anomaly.
2. Neonate with proven blood culture sepsis.
3. Neonates started on prior antibiotics.
4. Neonates with birth asphyxia.
5. Refusal to give consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate the efficacy of NLR and MPV with sepsis screen and blood culture in predicting neonatal sepsis |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the predictability of neonatal sepsis by NLR and MPV |
at the end of study |
|
|
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)
|
01/04/2025 |
| 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="6"
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
|
Neonates who fulfil the inclusion
criteria will be included in the study. Demographic data will be entered in pre designed proforma. At
the time of admission gestational age will be calculated using extended new ballard
scoring, Blood culture and sensitivity
will be sent at admission and/or before starting antibiotics. sepsis screen will be sent after 4 hour of life
/admission which ever is later. Peripheral smear will be used to
calculate neutrophil to leucocyte ratio and I:T ratio. All babies will be
managed as per standard protocols. Repeat sepsis screen and blood culture will
be sent if clinical condition worsens or warrants upgrade of antibiotics. This
will be documented as separate variable, will not be considered for sampling.
This will be analysed separately. Outcome of all cases, deaths/discharges and
number of days of hospital stay will be recorded. All data will be recorded in Microsoft
excel sheet. |