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CTRI Number  CTRI/2024/01/061969 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 12/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Predictors of Death in Children Admitted to a Pediatric Intensive Care Unit. 
Scientific Title of Study   Predictors of Mortality in Patients Admitted to a Tertiary Care Pediatric Intensive Care Unit. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Milind S Tullu 
Designation  Professor Additional  
Affiliation  Seth G.S. Medical College and KEM Hospital 
Address  Department of Pediatrics, Seth G.S. Medical College and KEM Hospital, Old KEM Hospital Building, Ward No. 1, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone  9869469974  
Fax    
Email  milindtullu@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Milind S Tullu 
Designation  Professor Additional  
Affiliation  Seth G.S. Medical College and KEM Hospital 
Address  Department of Pediatrics, Seth G.S. Medical College and KEM Hospital, Old KEM Hospital Building, Ward No. 1, Parel, Mumbai.


MAHARASHTRA
400012
India 
Phone  9869469974  
Fax    
Email  milindtullu@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Namita Nagar 
Designation  Junior Resident 
Affiliation  Seth G.S. Medical College and KEM Hospital 
Address  Department of Pediatrics, Seth G.S. Medical College and KEM Hospital, Old KEM Hospital Building, Ward No. 1, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone  9723471166  
Fax    
Email  namitanagar@gmail.com  
 
Source of Monetary or Material Support  
Seth G S Medical College and KEM Hospital, Parel, Mumbai 400012, Maharashtra, INDIA 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Milind S Tullu  Seth G.S. Medical College and KEM Hospital  Pediatric Intensive Care Unit, Old KEM Hospital Building, Ward No. 1, Ground Floor, Parel, Mumbai 400012.
Mumbai
MAHARASHTRA 		 9869469974

milindtullu@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee IEC II, Seth GS Medical College and KEM Hospital, Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G969||Disorder of central nervous system, unspecified, (2) ICD-10 Condition: N289||Disorder of kidney and ureter, unspecified, (3) ICD-10 Condition: K769||Liver disease, unspecified, (4) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, (5) ICD-10 Condition: J989||Respiratory disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  All consecutive patients admitted to the PICU from the age group of 1 month to 12 years of either gender will be enrolled in the study. 
 
ExclusionCriteria 
Details  Patients whose parents or guardians refuse to give informed consent and children below the age of 1 month or beyond 12 years will be excluded. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
In the patients admitted to the Pediatric intensive care unit to determine--
Factors associated with mortality and the length of PICU stay.
 		 At discharge from the PICU or at death of the patient 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="350"
Sample Size from India="350" 
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)   01/02/2024 
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="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  

Aims & Objectives:

The aims and objectives of this study are-

In the patients admitted to the Pediatric intensive care unit (PICU) --

1.      To determine the socio-demographic characteristics and clinical diagnosis/spectrum.

2.      To determine the outcome in terms of percentage mortality.

3.      To determine the factors associated with mortality &the length of PICU stay.

  

Materials &Methods:

Ethics:The study will be initiated after seeking approval from the “Institutional Ethics Committee (IEC)” of the institute/ hospital. The study will be conducted in compliance with the “Ethical Guidelines for Biomedical Research on Human Participants” by the Indian Council of Medical Research (ICMR).

Consent &Assent: Case enrollment will be done after a written informed consent from the parent/ guardian. Since patients in the PICU are critically ill, the assent will be procured from children aged 7 years and above, once the clinical condition of the child stabilizes and when they are in a position to give the assent.

Study design: Prospective, non-interventional, observational, single centre study.

Study duration: The study will be conducted over a period of 18 months (prospectively) after approval from the IEC. Each patient will be in the study till his/ her stay in the PICU.

Study site: The study will be conducted in patients admitted to the PICU of KEM hospital, Mumbai, which is a tertiary care, 14-bedded PICU with state-of-art facilities including mechanical ventilators, non-invasive monitors and other devices for delivering critical care. It is manned by at least 4 resident medical officers round the clock. One Additional Professor looks after the day-to-day clinical and administrative matters of the PICU and is assisted by one Associate Professor and one Assistant Professor. Fellows (MUHS) and senior registrars are also posted in the PICU (when available).

Inclusion Criteria: All consecutive patients admitted to the PICU from the age group of 1 month to 12 years of either gender will be enrolled in the study.

Exclusion criteria:Patients whose parents/guardians refuse to give informed consent and children below the age of 1month or beyond 12 years will be excluded.

Confidentiality:The participant’s details will not be disclosed at any point of time.

Total number of patients to be studied (sample size calculation):It has been noticed that the average number of admissions to the Pediatric ICU of KEM Hospital is around 350 per year. All the consecutive patients admitted to the Pediatric Intensive Care Unit (PICU)over a period of 1 year will be included in the study as a Convenience Sampling. Each patient will be in the study throughout his/her PICU stay i.e. till transferred out of PICU or till death.

Data Recording: Following data/ information will be recorded in a pre-designed case record form- CRF (from the patient’s hospital case sheets/ indoor medical papers)–

i. Age, Sex, Weight, Socio-economic status, duration of PICU stay, final diagnosis & system involved, co-morbidities & complications.

ii. Outcome will be recorded as Survival/ Death.

iii. Determinants of mortality will be analyzed as per the various demographic factors i.e. the age, sex, weight, socio-economic status, length of PICU stay and clinical factors i.e. the diagnosis, system involved, co-morbidities, PIM 2 score & complications (like shock, sepsis, nosocomial infections, & thrombocytopenia).

iv. Determinants of length of PICU stay will be analyzed by same (above mentioned) demographic and clinical factors (except the length of PICU stay).

The patient’s daily medical records will be scrutinized from admission until discharge from PICU or until death of the patient or transfer to the Pediatric ward, whichever is earlier. Readmission of the same patient to PICU will be counted as a separate case enrolled.  This study will not entail performing any new/ additional investigations or new/ additional treatment or any financial burden to the hospital or financial burden to the parent/ guardian.


Statistical analysis plan:

i. Age, Weight, Length of PICU stay (days) will be represented as mean (SD), mode & median.

ii. Variables like sex, diagnosis, system affected, co-morbidities, complications & outcome will be listed as percentage of total patients enrolled.

iii. Predictors of/ factors affecting the mortality &the length of stay will be analyzed by chi-square test (univariate analysis) and a p value<0.05 will be considered to be statistically significant.

iv. Regression analysis will be done for the factors that are found to be significant by the univariate analysis.

Expected Outcomes/Impact:

This study will help--

1.      To document the factors associated with mortality and length of stay in the PICU.

2.      This information will help rationalize the resources and help frame admission/discharge as well as treatment policy for the PICU.

 References:

1.      Diaz JV, Riviello ED, Papali A, Adhikari NKJ, Ferreira JC. Global Critical Care: Moving Forward in Resource-Limited Settings. Annals of Global Health 2019;85(1):3,1–11.

2.      Fowler RA, Adhikari NK, Bhagwanjee S. Clinical review: Critical care in the global context- disparities in the burden of illness, access, and economics. Critical Care 2008;12(5):225-230

3.      Dendir G, Awoke N, Alemu A, Sintayhu A, Eanga S, Teshoma M et al. Factors associated with the outcome of a pediatric patients admitted to intensive care unit in resource-limited setup: Cross-sectional study. Pediatric Health Med Ther  2023;14:71–79.

4.      Young MP, Birkmeyer JD. Potential reduction in mortality rates using an intensivist model to manage intensive care units. Effect Clinical Practice 2000;3(6):284-289.

5.      Edae G, Tekleab AM, Getachew M, Bacha T. Admission pattern and treatment outcome in Pediatric Intensive Care Unit, tertiary hospital, Addis Ababa, Ethiopia. Ethiopia Journal of Health Sciences 2022;32(3):497-504.

6.      Blessing I, Abhulimhen-Iyoha, Pooboni SK, Vuppali NKK. Morbidity pattern and outcome of patients admitted into a pediatric intensive care unit in India. Indian Journal of Clinical Medicine 2014;5:1-5.

7.      Ramawat P, Jain N. Morbidity and mortality profile of children admitted in a pediatric department- A single centre study. Asian Journal of Medical Sciences 2021;12(5):94-100.

8.      Ambike D, Bhavari V, Pawar N. A retrospective evaluation of morbidity patterns and outcome of patients admitted in pediatric intensive care unit in a tertiary care rural teaching hospital. International Journal of Contemporary Pediatrics 2019;6(5):2064-2067.

9.      El Halal MG, Barbieri E, Filho RM, Trotta Ede A, Carvalho PR. Admission source and mortality in a pediatric intensive care unit. Indian Journal of Critical Care Medicine 2012;16:81-86.

10.  Siddiqui NU, Ashraf Z, Jurair H, Haque A. Mortality patterns among critically ill children in a pediatric intensive care unit of a developing country. Indian Journal of Critical Care Medicine 2015;19:147-150.

11.  Teshager NW, Amare AT, Tamirat KS. Incidence and predictors of mortality among children admitted to the pediatric intensive care unit at the University of Gondar Comprehensive Specialised Hospital, Northwest Ethiopia: A prospective observational cohort study. British Medical Journal Open 2020;10(10):e036746.

12.  Kaur G, Vinayak N, Mittal K, Kaushik JS, Aamir M. Clinical outcome and predictors of mortality in children with sepsis, severe sepsis, and septic shock from Rohtak, Haryana: A prospective observational study. Indian Jour of Critical Care Medicine 2014;18:437-441.

13.  Hafta H, Hailu T, Medhaniye A, Teklit G. Assessment of pattern and treatment outcomes of patients admitted to pediatric intensive care unit, Ayder Referral Hospital, Tigray, Ethiopia, 2015. British Medical Journal Res Notes 2018;11(1):339-344.

14.  Khilani P, Sharma D, Singh R, Uttam R, Rajdev S, Makkar A et al. Demographic profile and outcome analysis of a tertiary level pediatric intensive care unit. Indian Journal of Pediatrics 2004;71(7):587-591.

15.  D Kapil, Bagga A. The profile and outcome of patients admitted to a pediatric intensive care unit. Indian Journal of Pediatrics 1993;60(1):5-10.

16.  Seifu A, Eshetu O, Tafesse D, Hailu S. Admission pattern, treatment outcomes, and associated factors for children admitted to pediatric intensive care unit of Tikur Anbessa Specialised Hospital, 2021: A retrospective cross-sectional study. British Medical Journal Anesthesiology 2022;13:1-8.

17.  Shah G, Shah B, Thapa A, Shah L. Admission patterns and outcome in a Pediatric intensive care unit in Nepal. British Journal of Medicine and Medical Research 2014;4(30):4939-4945.

18.  Punchak M, Hall K, Seni A, Buck WC, DeUgarte DA, Hartford E et al. Epidemiology of disease and mortality from a PICU in Mozambique. Pediatric Critical Care Medicine 2018;19(11):603-610.

 

 
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