| CTRI Number |
CTRI/2022/03/040754 [Registered on: 03/03/2022] Trial Registered Prospectively |
| Last Modified On: |
18/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Mortality in sick children with infection on different feeding regimens-A randomized control trial |
|
Scientific Title of Study
|
Mortality in critically ill children with sepsis on different feeding regimens– A randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mithlesh Kumar Tiwari |
| Designation |
Senior resident DM Pediatric critical care |
| Affiliation |
Post Graduate Institute Of Medical Education & Research Chandigarh |
| Address |
DEPT OF PEDIATRIC CRITICAL CARE
ADVANCED PEDIATRIC CENTER
PGIMER CHANDIGARH 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8408030033 |
| Fax |
|
| Email |
pandit.afmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Bansal |
| Designation |
Professor, Pediatrics |
| Affiliation |
Post Graduate Institute Of Medical Education & Research Chandigarh |
| Address |
DEPT OF PEDIATRIC CRITICAL CARE
ADVANCED PEDIATRIC CENTER
PGIMER CHANDIGARH 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
drarunbansal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mithlesh Kumar Tiwari |
| Designation |
Senior resident DM Pediatric critical care |
| Affiliation |
Post Graduate Institute Of Medical Education & Research Chandigarh |
| Address |
DEPT OF PEDIATRIC CRITICAL CARE
ADVANCED PEDIATRIC CENTER
PGIMER CHANDIGARH 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8408030033 |
| Fax |
|
| Email |
pandit.afmc@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
APC PGIMER |
| Address |
DEPT OF PEDIATRIC CRITICAL CARE
ADVANCED PEDIATRIC CENTER
PGIMER,CHANDIGARH-160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mithlesh Kumar Tiwari |
PGIMER |
DEPT OF PEDIATRIC CRITICAL CARE
ADVANCED PEDIATRIC CENTER
PGIMER,CHANDIGARH-160012
Chandigarh
CHANDIGARH |
8408030033
pandit.afmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: R652||Severe sepsis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
RCT arm : Hypocaloric hyperproteic |
All children admitted in PICU will be screened for enrollment prior to randomization. Stratified randomization will be done with computer generated randomization sequence to assign participants to one of the 3 intervention arms.
3 intervention arms are:
1. Normocaloric normoproteic(standard arm)
2. Hypocaloric hyperproteic
3. Hypercaloric normoproteic
HYPOCALORIC HYPERPROTTEIC ARM:
Hypocaloric feeding- 0.5–0.9 times the REE(Resting energy expenditure)
Hyperproteic feeding - 2.6gm/kg/day(Protein)
Route: Enteral
Frequency : 3hrly NG feed
Duration: Completion of 7 days of assigned feed or till hospital discharge or death whichever is earlier
|
| Intervention |
RCT arm: Hypercaloric normoproteic |
HYPERCALORIC NORMOPROTEIC ARM:
Hypercaloric feeding – 1.2 to 1.5 times of REE,
Normoproteic - 1.5gm/kg/day(protein)
Route: Enteral
Frequency : 3hrly NG feed
Duration: Completion of 7 days of assigned feed or till hospital discharge or death whichever is earlier |
| Comparator Agent |
RCT arm: Normocaloric normoproteic( standard arm) |
NORMOCALORIC NORMOPROTEIC ARM
Normocaloric - 100% of REE
Normoproteic - 1.5gm/kg/day(protein)
Route: Enteral
Frequency : 3hrly NG feed
Duration: Completion of 7 days of assigned feed or till hospital discharge or death whichever is earlier |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Critically ill children with sepsis as per Sepsis-3 definition |
|
| ExclusionCriteria |
| Details |
Enteral feed intolerance as defined
Gastrointestinal disease(Ileus,Bleeding,Perforation)
On Renal replacement therapy(RRT)
Known case of Chronic renal failure
known case of Acute liver failure
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of different feeding regimens on mortality in critically ill children with sepsis in PICU |
After 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of PICU stay
Duration of Hospital stay
Pre-existing malnutrition in children admitted to PICU
Vasopressor free days
Incidence of hypo/hyperglycemia
Incidence of health care associated infection
Incidence of AKI as per KIDIGO
Incidence of transaminitis
Time to achieve full feeds
|
4weeks |
|
|
Target Sample Size
|
Total Sample Size="279"
Sample Size from India="279"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/03/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A triple arm randomized control trial will be conducted at PICU of tertiary care center to assess the effect of different feeding regimens in critically ill children with sepsis in PICU with a Primary objective : Mortality at 28days and secondary objectives : Duration of PICU/Hospital stay, preexisting malnutrition in children admitted to PICU, vasopressor free days, Incidence of hypo/hyperglycemia, Incidence of health care associated infection, Incidence of AKI, Incidence of transaminitis , Time to achieve full feed |