| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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
|
|
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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. |