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CTRI Number  CTRI/2025/08/093764 [Registered on: 27/08/2025] Trial Registered Prospectively
Last Modified On: 26/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Can Neutrophil-to-lymphocyte ratio help predict recovery in seriously ill children admitted to intensive care  
Scientific Title of Study   NEUTROPHIL TO LYMPHOCYTE RATIO AS A MARKER OF OUTCOME IN CRITICALLY ILL CHILDREN ADMITTED TO PAEDIATRIC INTENSIVE CARE UNIT 
Trial Acronym  NLR 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ritwik Nath 
Designation  Junior Resident 
Affiliation  Dutta Meghe Institue of Higher Education and Research 
Address  Department of Pediatrics, AVBRH Campus, Sawangi, Meghe, Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  8859089888  
Fax    
Email  ritwik.nath3709@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Punam Uke 
Designation  Associate Professor 
Affiliation  Datta Meghe Institue of Higher Education and Research  
Address  Department of Pediatrics, Datta Meghe Institute Of Higher Education and Research, AVBRH Campus, Sawangi, Meghe, Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  8551839785  
Fax    
Email  drukepunam@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Punam Uke 
Designation  Associate Professor 
Affiliation  Dutta Meghe Institue of Higher Education and Research  
Address  Department of Pediatrics, AVBRH Campus, Sawangi, Meghe, Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  8551839785  
Fax    
Email  drukepunam@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha, Maharashtra, India 442001 
 
Primary Sponsor  
Name  Dutta Meghe Institue of Higher Education and Research 
Address  Sawangi Meghe Wardha 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ritwik Nath  Acharya Vinoba Bhave Rural Hospital  Department of Paediatrics, Acharya Vinobha Bhave Rural Hospital, Sawangi Meghe Wardha
Wardha
MAHARASHTRA 
8859089888

ritwik.nath3709@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institue of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J439||Emphysema, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  31.00 Day(s)
Age To  18.00 Year(s)
Gender  Both 
Details  All the patients admitted to the PICU in the age group of 1 month – 18 years

Picu stay more than 24 hours 
 
ExclusionCriteria 
Details  1. Refusal of consent.
2. Admission for scheduled procedures normally cared for in a PICU
3.PICU stay less than 24 hours.
4. Patients with haemolytic disorders.
5. Recent blood transfusion within 7 days. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study mortality and morbidity in children admitted to PICU  Assessment will be done at 24 hours and 48 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
Neutrophil to lymphocyte ratio as a marker of outcome in critically ill children admitted to paediatric intensive care unit  At 24 & 48 hours 
 
Target Sample Size   Total Sample Size="267"
Sample Size from India="267" 
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)   09/09/2026 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  by email id

  6. For how long will this data be available start date provided 01-02-2023 and end date provided 30-08-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
The PICU is constantly in a fluctuating state depending on the constantly changing
conditions of the critically ill patients being cared for there, while having a high
mortality and morbidity rate. In India, the most common diseases among children
admitted to the Paediatric intensive care unit (PICU) include respiratory infections
(such as pneumonia and bronchiolitis), sepsis, dengue fever, malaria and Acute
Respiratory Distress Syndrome(ARDS). Other common conditions include, injuries
from accidents, poisoning and neurological disorders. In addition, malnutrition and
undernutrition are also prevalent among critically ill children in India and contribute to
poor outcomes. Before severe sepsis develops into septic shock, early identification
of patients who may progress to severe sepsis and initiation of appropriate antibiotic
therapy and efficient fluid resuscitation may reduce mortality(1) Due to the high
burden of infectious diseases in India, PICUs often have a high proportion of patients
with infectious etiologies. It is said that the art of medicine is in
diagnosing/recognising a condition before its onset. This statement only emphasizes
the special need of patients to have predictability markers which can help predict the
patient’s outcome as early and as accurately as possible. Procalcitonin (PCT) and
C‐reactive protein (CRP) have been used in evaluation of the severity of an episode
of sepsis along with patient therapeutic responses and guide duration of therapy in
critically ill patients. (2) However, due to their nonspecific character and insufficient
predictive value for the individual, urgent identification of a more robust biomarker is
essential. An ideal prognostic score should be easy, comprehensible, minimally
invasive. The neutrophils and the lymphocytes are the key cellular component of the
human host defense system.The neutrophil to lymphocyte ratio (NLR) is an
emerging marker of inflammation in paediatric population that is used to assess the
severity of disease in critically ill children. A higher NLR may indicate a severe
inflammatory progression in the patient (3). Although a number of clinical biomarkers
in critically ill have been extensively studied, few have been examined in paediatric
population (4) As a biomarker, the predictive and prognostic value of NLR in
pulmonary and cardiovascular disease, as well as cancer, has been studied
(5)..While normal values vary depending on the age, sex and other factors, generally
a NLR greater than 3 in paediatric population is considered elevated (6) .Although
neutrophil-to-lymphocyte ratio (NLR) has been extensively studied in several
diseases in adults , its role in paediatric population remains unclear. NLR has been

studied as a prognostic marker for Sepsis in few paediatric studies but its role in
other diseases has not been studied till now .Our study aimed to assess the
predictive significance of NLR as a parameter for outcome in all critically ill patients
in the paediatric intensive care unit (PICU). However, it is important to note that the
NLR is not specific to any one disease or condition, and an elevated NLR can be
seen in a variety of illnesses including infections, malignancies, and inflammatory
disorders and hence can be used as a predictive marker for all critically ill children
admitted in PICU.
 
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