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CTRI Number  CTRI/2024/02/062533 [Registered on: 12/02/2024] Trial Registered Prospectively
Last Modified On: 02/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   A study to evaluate nutritional practices in very ill children with cancer 
Scientific Title of Study   Prospective observational study of nutritional practices and its correlation to outcomes in critically ill children with cancer 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
4245_Protocol Version 1.1 dated 01.01.24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shilpushp Bhosale 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Dept of Anaesthesia, Critical Care and Pain, Main Building, Second floor, Tata Memorial Hospital

Mumbai
MAHARASHTRA
400012
India 
Phone  9619310657  
Fax    
Email  shilbhosale@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shilpushp Bhosale 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Dept of Anaesthesia, Critical Care and Pain, Main Building, Second floor, Tata Memorial Hospital


MAHARASHTRA
400012
India 
Phone  9619310657  
Fax    
Email  shilbhosale@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Akash Golani 
Designation  DM Critical care post graduate student 
Affiliation  Tata Memorial Centre 
Address  Dept of Anaesthesia, Critical Care and Pain, Main Building, Second floor, Tata Memorial Hospital

Mumbai
MAHARASHTRA
400012
India 
Phone  9164612172  
Fax    
Email  akashgolani93@gmail.com  
 
Source of Monetary or Material Support  
Dept of Anaesthesia, Critical care and Pain, Tata Memorial Hospital 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dept of Anaesthesia, Critical care and Pain, Second floor, Main building Tata Memorial Hospital 
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 Shilpushp Bhosale  Tata Memorial Hospital  Dept of Anaesthesia, Critical Care and Pain, Second floor, Main Building, Tata Memorial Hospital, Parel, Mumbai 400012
Mumbai
MAHARASHTRA 
9619310657

shilbhosale@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee II   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  NA 
Comparator Agent  Nil  NA 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. Patients admitted in ICU Age 2 - 15 years.
2. Patients likely to be admitted in ICU beyond 48 hours
 
 
ExclusionCriteria 
Details  Postoperative patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the nutrition practices in paediatric intensive care unit in terms of timing, dosing and delivery of enteral and parenteral nutrition  Each day during ICU stay until hospital discharge 
 
Secondary Outcome  
Outcome  TimePoints 
1. Hospital Mortality
2. Incidence of Malnutrition and Factors influencing the adequacy of calorie intake and its relationship to clinical outcomes
 
Until hospital discharge 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   15/02/2024 
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  

INTRODUCTION

Incidence of malnutrition is 35.5% in our country. It is higher in critically ill children. The adverse effects of chemotherapy, feed intolerance, feeding interruptions, frequent admissions to hospital/icu and overall catabolic state of these children is a deterrent to their nutrition and growth. Nutrition status declines during the icu stay.1

Malnutrition has been associated with increased morbidity (infections, weakness, prolonged mechanical ventilation, and delayed recovery) as well as increased mortality.

In 2013, the Academy of Nutrition and Dietetics and American Society of Parenteral and Enteral Nutrition (ASPEN) defined paediatric malnutrition as “an imbalance between nutrient requirements and intake, resulting in cumulative deficits of energy, protein or micronutrients that may negatively affect growth, development and other relevant outcomes”.

The European Society for Clinical Nutrition and Metabolism (ESPEN) and the European Society for Pediatrics Gastroenterology, Hepatology and Nutrition (ESPGHAN) recommend nutritional risk screening for hospitalized children during admission, to facilitate the detection of children nutritionally at risk and to allow the physician to make an appropriate nutritional support plan. Even if several pediatric nutritional risk scores are reported in literature, there is no consensus on the “ideal” screening tool and, often, nutritional screening is not yet widely performed.


AIM

To study the nutrition practices in paediatric intensive care unit in terms of timing, dosing and delivery of enteral and parenteral nutrition.

METHODOLOGY

1.    We will commence the study after approval from the Hospital Ethics Committee approval and registration with the Clinical Trials registry of India.

2.    This is a Prospective observational case control study, which will be conducted in ICU in Tata Memorial Hospital.

3.    Nutritional practices will be recorded during the  ICU and patients will be followed up until hospital discharge.

4.    We will also record Nutrition scores, Incidence of malnutrition by anthropometric data. For haematology patients below the age of 5, we will utilise the weight-for-height (WFH) ratio as a means to assess their nutritional status.

5.    For patients aged 5 and above, we rely on the body mass index (BMI) to assess malnutrition. BMI takes into account both weight and height and aids in categorising individuals as underweight, normal weight, overweight, or obese.

6.    We will be measuring the weight of the child on a weighing scale directly or if it’s safe and feasible, indirectly when held by the parent (standing on the weighing scale) by subtracting parent’s weight from total. Children are weighed daily in the wards, so we will obtain the admission weight from there if not feasible in the ICU.

7.    In cases of solid tumor patients, we acknowledge that weight alone may not accurately reflect their nutritional status due to the presence of tumor mass. Therefore, when assessing malnutrition using weight-for-height or BMI, we also incorporate the measurement of mid-upper arm circumference (MUAC) as per Frisancho. MUAC provides additional insights into muscle mass and overall nutritional status. Triceps skin fold (TSF) is measured as per St. Jude children’s Research Hospital algorithm which is defined as TSF < 5th Percentile as severely depleted, 5-10thpercentile as moderately depleted and TSF >10th percentile as adequate.

8.    Anthropometric data will be measured according to latest CDC guidelines as of 2022 under the following headings of – Measuring recumbent length, measuring weight, Arm circumference and skin fold thickness measurements. Measurements will be taken according to techniques mentioned in the National Health and Nutrition Examination Survey (NHANES) by the CDC. Techniques used to obtain accurate anthropometric measurements have been attached to the appendix.

9.    The values obtained will be then analysed using the WHO 2006 and IAP growth charts. Charts have been attached in the appendix.

10. BMI will be calculated using kilograms obtained by weighing the participant and height obtained in metres, and will be then analysed as kg/m2, interpreted as per IAP growth charts.

11. According to the American Association of Pediatrics (AAP), clinically significant weight loss depends on age. Newborns may lose 5% to 10% of their birth weight in the first few days after birth; losses greater than 12% are concerning. In children, unintentional weight loss greater than 5% from baseline may be concerning.

12. The refeeding syndrome appears in patients who have had a reintroduced and/or increased caloric intake. ASPEN proposed the following diagnostic criteria for refeeding syndrome as being, A reduction in serum levels in one or any of the electrolytes, phosphorus, potassium or magnesium by 10–20% (mild refeeding syndrome), 20–30% (moderate refeeding syndrome), or >30% (severe refeeding syndrome), or organ dysfunction results from a decrease in any of these and/or as a result of thiamine deficiency (severe refeeding syndrome). Combined with this occurrence within 5 days of recommencing or significantly increasing energy provision.

13. We will also record Time to initiation of enteral/parenteral nutrition and time to achieve target nutrition goals, Dosing (calories, protein, continuous/ bolus) and route of enteral or parenteral nutrition, Nutrition free days, Incidence of feed intolerance, overfeeding/ refeeding syndrome, PRISM/PIM III scores, acquired nosocomial infections define (VAP/UTI/BSI) etc.

14. As indicators of feeding intolerance, we will look for the following symptoms and signs.

15. Symptoms – Vomiting (altered milk, bile or blood stained).

16. Signs –

1.    Abdominal distention (>2cm increase in abdominal girth from baseline)

2.    Abdominal tenderness

3.    Gastric Residual Volume

4.    Reduced or absent bowel sounds

5.    Systemic signs (bradycardia, shock, apnea, asystole)

 

Statistical analysis plan

Descriptive statistics will be presented with numbers and proportions and medians and interquartile ranges (IQR) as appropriate. Statistical analysis will be performed using IBM-SPSS version 25.0. Statistical analysis for continuous variables will be performed by using Analysis of Variance (ANOVA) and Chi square test for categorical variables. We will perform Multivariate analysis using the cox regression method to identify independent predictors of mortality and assess correlation of malnutrition with icu Outcomes. The significant level will be set to 5% and all reported p-value will be two sided.

 
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