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CTRI Number  CTRI/2023/05/053144 [Registered on: 26/05/2023] Trial Registered Prospectively
Last Modified On: 23/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Clinical Features and Results of Children Receiving Respiratory Support in Pediatric Intensive Care Unit 
Scientific Title of Study   Clinical Characteristics and Outcomes of Individuals Admitted in Pediatric Intensive Care Unit Receiving Respiratory Support.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kulal Prasali Sadashiva 
Designation  Post-graduate 
Affiliation  Manipal College of Health Professions 
Address  Department of Respiratory Therapy, Manipal College of Health Professions, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8692958775  
Fax    
Email  prasali.mchpmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Leslie Edward S Lewis 
Designation  Professor and Head of Pediatrics 
Affiliation  Kasturba Medical College 
Address  Department of Pediatrics, KMC Manipal

Udupi
KARNATAKA
576104
India 
Phone  9449208476  
Fax    
Email  leslie.lewis@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Kulal Prasali Sadashiva 
Designation  Post-graduate 
Affiliation  Manipal College of Health Professions 
Address  Department of Respiratory Therapy, Manipal College of Health Professions, MAHE, Manipal


KARNATAKA
576104
India 
Phone  8692958775  
Fax    
Email  prasali.mchpmpl2022@learner.manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital, Manipal 
 
Primary Sponsor  
Name  Kulal Prasali Sadashiva 
Address  Department of Respiratory Therapy, Manipal College of Health Professions, Manipal- 576104 
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 
Kulal Prasali Sadashiva  Kasturba Hospital  Pediatric Intensive Care Unit, KH, Manipal
Udupi
KARNATAKA 		 8692958775

prasali.mchpmpl2022@learner.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-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  2.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Pediatrics less than equal to 18 years on respiratory support in Pediatric Intensive Care Unit. 
 
ExclusionCriteria 
Details  Infants with < 2 months of age. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1) Clinical characteristics of individuals on respiratory support in PICU.
2) Indication for respiratory support.
3) Average days on respiratory support.
4) Average length of stay in PICU in days.
5) Mortality Rate in percentage. 		 1) Within 48 hours of admission to PICU.
2) Immediately when respiratory support is initiated.
3) Noted from initiation to termination of respiratory support.
4) Noted from admission to discharge/death.
5) After declaration of death. 
 
Secondary Outcome  
Outcome  TimePoints 
1) Most frequently used mode of Invasive ventilation.
2) Factors associated with outcome of patients on respiratory support.
3) Indication for escalation of respiratory support [Oxygen therapy to Non-invasive ventilation
(NIV), NIV to Invasive ventilation]. 		 1) Immediately after initiation of invasive ventilation.
2) After declaration of death or discharge from PICU.
3) Immediately when respiratory support is escalated. 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="161" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/06/2023 
Date of Study Completion (India) 31/01/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
Most of the children in the Pediatric Intensive Care Unit (PICU) require respiratory support. This prospective observational study will investigate the trends in clinical characteristics and outcomes of children on respiratory support in the Pediatric Intensive Care Unit. Analyzing the trends in clinical characteristics will help in identifying the
etiologies that require respiratory support the most. Additionally, this study will help to explore the common reasons for initiating and escalating respiratory support in children. Furthermore, the outcomes of this study will find relation between PIM3 score and other factors that may lead to mortality and need for invasive ventilation. The primary outcomes include 1) Clinical characteristics of individuals on respiratory support in PICU. 2) Indication for respiratory support. 3) Average days on respiratory support. 4) Average length of stay in PICU in days. 5) Mortality Rate in percentage. The secondary outcomes include 1) Most frequently used mode of Invasive ventilation. 2) Factors associated with the outcome of patients on respiratory support. 3) Indication for escalation of respiratory support. The ancillary outcomes include: 1) Association between characteristics of children on respiratory support and mortality. 2) Association between characteristics on respiratory support and type of respiratory support. 3) Association between age and primary diagnosis of children on respiratory support. 4) Correlation between various factors. 
 
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