CTRI

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CTRI Number

CTRI/2026/02/105038 [Registered on: 27/02/2026] Trial Registered Prospectively

Last Modified On:

26/02/2026

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cohort Study

Study Design

Other

Public Title of Study

To compare neonates having sepsis with culture positive to neonates with sepsis without culture positive in terms of their demographics, risk factors, presentations and response to antibiotics.

Scientific Title of Study

Comparison of clinical characteristics and outcomes of neonates with culture-negative versus culture-positive sepsis: a prospective cohort 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	Raghvendra Singh Patel
Designation	Senior Resident
Affiliation	Bharati hospital and research centre
Address	NICU department of neonatology 2nd floor Bharti hospital and research centre Satara Road Dhanakwadi Pune MAHARASHTRA 411043 India
Phone	7275892180
Fax
Email	raghvendrasingh.patel@bharatividyapeeth.edu

Details of Contact Person
Scientific Query

Name	Dr Sujata Deshpande
Designation	Professor
Affiliation	Bharati hospital and research centre
Address	NICU Department of neonatology 2nd floor Bharti hospital and research centre Bharti Vidyapeeth university Satara Road Dhanakwadi Pune MAHARASHTRA 411043 India
Phone	7275892180
Fax
Email	sujata.deshpande@gmail.com

Details of Contact Person
Public Query

Name	Raghvendra Singh Patel
Designation	Senior Resident
Affiliation	Bharati hospital and research centre
Address	NICU Department of neonatology 2nd floor Bharti hospital and research centre Bharti Vidyapeeth university Satara Road Dhanakwadi Pune MAHARASHTRA 411043 India
Phone	7275892180
Fax
Email	raghvendrasingh.patel@bharatividyapeeth.edu

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Bharati Hospital and Research Centr
Address	BHRC, Bharati Vidyapeeth university Satara Road Dhanakwadi Pune 411043
Type of Sponsor	Research institution and hospital

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 Raghvendra Singh Patel	Bharati Hospital and Research Centre	NICU Department of neonatology, 2nd floor BHRC , Bharati Vidyapeeth University, Satara Road , Dhanakwadi 411043 Pune MAHARASHTRA	7275892180 raghvendrasingh.patel@bharatividyapeeth.edu

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional ethics committee Bharati Medical college	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: P35-P39\|\|Infections specific to the perinatal period,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil
Intervention	Nil	Nil

Inclusion Criteria

Age From	0.00 Day(s)
Age To	28.00 Day(s)
Gender	Both
Details	All Neonates (0 to 28 days) admitted to NICU during the study period and clinically suspected to have sepsis by the treating neonatal physician.

ExclusionCriteria

Details

Neonates (0 too 28 days) with the following conditions will be excluded from the study:
1. Major congenital anomalies incompatible with life
2. Blood culture not taken before starting antibiotics
3. Prior sepsis episode during the same admission and patient still not recovered
4. Only the first episode of sepsis for each patient will be included for analysis

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To compare the rates of major organ dysfunction between neonates with culture-negative (probable) and culture-positive (proven) sepsis admitted to the NICU.	Occurrence of any one or more of the Major organ dysfunction after the time of sepsis diagnosis, until the end of antimicrobial course, or 21 days, whichever is later.

Secondary Outcome

Outcome

TimePoints

To compare the following between neonates with culture-negative versus and culture-positive
sepsis:
1. Cause-specific mortality and 28-day all-cause mortality
2. Number of major organ dysfunction secondary to sepsis
3. Morbidity rates other than major organ dysfunction
4. Antibiotic exposure patterns (duration, escalation, de-escalation, prolonged empirical use).
5. Relapse of sepsis within 72 hours of discontinuation of antimicrobial therapy.
6. Severity of illness (peak n-SOFA score) during the course of sepsis

Occurrence of secondary outcome after the time of sepsis diagnosis, until the end of antimicrobial course, or 21 days, whichever is later.

Target Sample Size

Total Sample Size="178"
Sample Size from India="178"
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)

15/03/2026

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)

Open to Recruitment

Recruitment Status of Trial (India)

Open to Recruitment

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 causes high morbidity and mortality in NICUs worldwide especially in low and middle income countries like India where 51 to 56.7 percent of cases are culture negative despite clinical signs. The Delhi Neonatal Infection Study found sepsis incidence at 14.3 percent with culture negative cases at 8.1 percent or 56.7 percent of total sepsis and mortality risks of 8.6 percent for culture negative and 27.7 percent for culture positive. Data on culture negative sepsis outcomes and management is limited and inconsistent. This study will measure its proportion in NICU admissions compare demographics risk factors presentation and outcomes with culture positive sepsis and test if culture negative cases have shorter recovery less severity and different antibiotic use to guide better care and stewardship.