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CTRI Number  CTRI/2019/06/019756 [Registered on: 19/06/2019] Trial Registered Prospectively
Last Modified On: 25/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Mode of nutritional delivery]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of feeding by pump continuously and feeding by syringe intermittently in sick children admitted in ICU 
Scientific Title of Study   Comparison of protocol based continuous and intermittent tube feeding in mechanically ventilated critically ill children – Open Label Randomized Controlled Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  U Vijaya kumar  
Designation  DM Senior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Room no 3058, Department of Pediatrics, Teaching block, 3rd floor, AIIMS

New Delhi
DELHI
110029
India 
Phone  9871857576  
Fax    
Email  drvijayk1188@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rakesh Lodha 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no 3058, Department of Pediatrics, Teaching block, 3rd floor, AIIMS

New Delhi
DELHI
110029
India 
Phone  01126593621  
Fax    
Email  rlodha1661@gmail.com  
 
Details of Contact Person
Public Query
 
Name  U Vijaya kumar  
Designation  DM Senior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Room no 3058, Department of Pediatrics, Teaching block, 3rd floor, AIIMS

New Delhi
DELHI
110029
India 
Phone  9871857576  
Fax    
Email  drvijayk1188@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical sciences Ansari nagar east New Delhi Pin 110029 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Room no 3058,Department of Pediatrics, 3rd floor, Teaching block AIIMS New Delhi 
Type of Sponsor  Government medical college 
 
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 
U Vijaya Kumar  All India Institute of Medical Sciences  PICU, D5 ward 5th floor, Ward block Division of Pediatric Pulmonology and Intensive care Department of Pediatrics
New Delhi
DELHI 
9871857576

drvijayk1188@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS, New Delhi Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E43||Unspecified severe protein-caloriemalnutrition, (2) ICD-10 Condition: K638||Other specified diseases of intestine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  continuous feeding  continuous feeding will be given instead of intermittent bolus feeding in critically children  
Comparator Agent  intermittent feeding  intermittent bolus feeding is usually given in critically ill children 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Critically ill children, age 1 month (corrected age) - 18 years admitted in PICU
Who are mechanically ventilated (invasive /non-invasive) with or without inotropic support
Who would be started on enteral nutrition through naso/oro-gastric tube
 
 
ExclusionCriteria 
Details  Children with known malabsorption syndrome and chronic diarrhea
Children on peritoneal dialysis or hemodialysis
Children who are admitted for elective pre- and post- procedure care
Enteral feeding initiated before admission to PICU
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Time required to reach target calories which is defined as 70 percent of calories out of total calorie requirement calculated by using the age and sex specific WHO formula  10 days 
 
Secondary Outcome  
Outcome  TimePoints 
Children who achieve primary outcome and continue to receive the target calorie for 48 hrs without interruption   10 days 
Children who achieve 70% of calorie requirement on day 7 of PICU stay   7 days 
Time required to reach target protein i.e. 1.5g/kg/day as per ASPEN 2017  10 days 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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   Phase 4 
Date of First Enrollment (India)   01/07/2019 
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="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Malnutrition is a major problem in children admitted to critical care unit. Enteral nutritional delivery plays an important role in determining the clinical outcomes in this population. As per recent guidelines by ASPEN (American Society of Parenteral and Enteral Nutrition), in critically ill children enteral nutrition should be initiated < 48 hours of admission to PICU and 2/3rd of energy requirement must be achieved in first week which is beneficial. However due to factors like feed intolerance, disease severity, gut injury and barriers of enteral nutrition, there is a delay in initiation and progression in nutritional delivery. Of the factors mentioned above feed intolerance is the major one delaying the achievement of target calories and protein. One way of improving feed tolerance is changing the mode of delivery from intermittent bolus to continuous.

Studies in critically ill children comparing continuous and intermittent tube feeding are lacking and two earlier studies have controversial results. Studies in critically ill adults have inconsistent results. No clear recommendation has been made for the mode of delivery of enteral nutrition in critically ill children. Given the magnitude of problem of malnutrition in critically ill children and outcome benefits achieved by supplementation of target calorie and protein in them, it necessary to have evidence on mode of delivery of enteral nutrition. Although intermittent feeding is more physiological, continuous feeding which constantly delivers the nutrition without increasing the stress on dysfunctional gut in critically ill may have additional advantages. In view of insufficient evidence and possibility of achieving target nutritional requirement earlier in continuous feeding with better feed tolerance than intermittent feeding, we plan to conduct a study to compare the two modes of tube feeding in critically ill children.

 
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