CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2026/03/106349 [Registered on: 17/03/2026] Trial Registered Prospectively

Last Modified On:

17/03/2026

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cohort Study

Study Design

Other

Public Title of Study

Factors Affecting Recovery and Survival in Children with Severe Infection (Sepsis) who Require Breathing Support

Scientific Title of Study

Clinical Profile, Prognostic Factors and Outcomes in Children With Sepsis Requiring Respiratory Support.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Ms Kulal Prasali Sadashiva
Designation	Part-Time PhD candidate
Affiliation	Manipal College of Health Professions, MAHE, Manipal
Address	Department of Respiratory Therapy, Manipal College of Health Professions, MAHE, Manipal Udupi KARNATAKA 576104 India
Phone	8692958775
Fax
Email	prasali.sk@manipal.edu

Details of Contact Person
Scientific Query

Name	Dr Sandeep Kumar BK
Designation	Associate Professor
Affiliation	Kasturba Medical College, MAHE, Manipal
Address	Department of Pediatrics, Kasturba Medical College, MAHE, Manipal Udupi KARNATAKA 576104 India
Phone	8197120018
Fax
Email	kumar.sandeep@manipal.edu

Details of Contact Person
Public Query

Name	Ms Kulal Prasali Sadashiva
Designation	Part-Time PhD candidate
Affiliation	Manipal College of Health Professions, MAHE, Manipal
Address	Department of Respiratory Therapy, Manipal College of Health Professions, MAHE, Manipal Udupi KARNATAKA 576104 India
Phone	8692958775
Fax
Email	prasali.sk@manipal.edu

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Ms Kulal Prasali Sadashiva
Address	4th Floor, Department of Respiratory Therapy, Manipal College of Health Professions, MAHE, Manipal-576104, Karnataka, India
Type of Sponsor	Other [Self]

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 Sandeep Kumar BK	Kasturba Hospital	2nd Floor, Pediatric Intensive Care Unit, Department of Pediatrics, Kasturba Medical College and Hospital, MAHE, Manipal Udupi KARNATAKA	8197120018 kumar.sandeep@manipal.edu

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: B998\|\|Other infectious disease,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil
Intervention	Nil	Nil

Inclusion Criteria

Age From	1.00 Month(s)
Age To	18.00 Year(s)
Gender	Both
Details	Children 1 month - 18 years with sepsis requiring respiratory support.

ExclusionCriteria

Details

Neonates
Children diagnosed with major lung/airway malformations
Denial of consent
Mortality within 24 hours of admission
Children with malignancy.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Identification of clinical, laboratory and radiological factors that help predict 28-day outcomes in children with sepsis requiring respiratory support.	Clinical and laboratory factors will be assessed within 24 hours of sepsis diagnosis. Radiological factors will be within 48 hours of sepsis diagnosis.

Secondary Outcome

Outcome	TimePoints
Evaluation of Phoenix-4, PELOD 2, pSOFA and modified PRISM-3 score to predict mortality in septic children. Correlation between RALE and PLUS score in septic children requiring respiratory support.	Based on when death occured or 28-days, whichever is earlier. Based on when respiratory support was provided.

Target Sample Size

Total Sample Size="135"
Sample Size from India="135"
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)

28/03/2026

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="3"
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

A prospective observation study will be conducted among children 1 month to 18 years of age diagnosed with sepsis. The aim of the study is to assess the clinical profile and identify the prognostic factors of mortality in children with sepsis requiring respiratory support. Neonates, Children diagnosed with major lung/airway malformations, Denial of consent, Mortality within 24 hours of admission and Children with malignancy will not be included in the study. The primary objective of the study is to assess the clinical profile and identify the prognostic factors of mortality in children with sepsis requiring respiratory support. The secondary objectives are 1.To study the 24-hour predictive factors of outcomes such as mortality, mode of respiratory support, days on respiratory support, length of stay in PICU in septic children requiring respiratory support. 2. To identify the best scoring system to prognosticate outcomes in children with sepsis. 3. To correlate Pediatric Lung Ultrasound Score (PLUS) and Radiographic Assessment of Lung Edema (RALE) score in septic children requiring respiratory support.