| CTRI Number |
CTRI/2024/06/068348 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Enteral Tube Feeding] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The difference between continuous and intermittent enteral feeding with naso gastric tube in paediatric critically ill children. |
|
Scientific Title of Study
|
COntinuous Versus INtermittent Enteral tube feeding in Critically ill children-An open- label randomized controlled trial |
| Trial Acronym |
CONVINCE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akhila Gujarathi |
| Designation |
PG JR -1 |
| Affiliation |
AIIMS Raipur |
| Address |
Pediatric Intensive Care Unit,Block No-2C3,2nd Floor,Gate NO-4,Great Eastern Road,opposite Gurudwara, AIIMS Campus,Tatibandh,Raipur,Chattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
7095255126 |
| Fax |
|
| Email |
akhilagujarathi11189@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manas Ranjan Sahoo |
| Designation |
Associate professor |
| Affiliation |
AIIMS Raipur |
| Address |
Pediatric Intensive Care Unit,Block No-2C3,2nd floor,Gate NO-4, Great Eastern Road,opposite Gurudwara, AIIMS Campus,Tatibandh,Raipur,Chattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
7893230151 |
| Fax |
|
| Email |
drmrsahoo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manas Ranjan Sahoo |
| Designation |
Associate professor |
| Affiliation |
AIIMS Raipur |
| Address |
Pediatric Intensive Care Unit,Block No-2C3,2nd floor,Gate NO-4,Great Eastern Road,opposite Gurudwara, AIIMS Campus,Tatibandh,Raipur,Chattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
7893230151 |
| Fax |
|
| Email |
drmrsahoo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pediatric Intensive Care Unit ,Block No-2C3,2nd floor,Gate NO-4,Great Eastern Road,opposite Gurudwara, AIIMS Campus,Tatibandh,Raipur,Chattisgarh,India,PINCODE-492099 |
|
|
Primary Sponsor
|
| Name |
AIIMS Raipur |
| Address |
All India Institute Of Medical Sciences , Gate No 1,Great Eastern Road,opposite Gurudwara, AIIMS Campus,Tatibandh,Raipur,Chattisgarh 492099 |
| 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 |
| Dr Akhila Gujarathi |
All Institute of Medical Sciences,Raipur |
Pediatric Intensive Care Unit,Block No-2C3,2nd Floor,Gate No 4,Great Eastern Road,opposite Gurudwara,Tatibandh,Raipur,Chhattisgarh,India 492099
Raipur
CHHATTISGARH |
7095255126
akhilagujarathi11189@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,All India Institute of Medical Sciences,Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J80||Acute respiratory distress syndrome, (2) ICD-10 Condition: I959||Hypotension, unspecified, (3) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Continuous enteral tube feeding. |
Critically ill children satisfying the inclusion and exclusion criteria will be enrolled and randomized into group A and group B. In group A(Intervention group), Continuous feeding is initiated within 24 hours of admission to PICU provided that they are hemodynamically stable and it will be administered 24 hours a day with maximum interruption period of 2 hours. The study intervention will lasts until admission day 7, initiation of oral intake or discharge from PICU whichever earlier. |
| Comparator Agent |
Intermittent enteral tube feeding |
Critically ill children satisfying the inclusion and exclusion criteria will be enrolled and randomized into group A and group B.Subjects in group B will receive intermittent bolus enteral tube feedings every three hourly. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
All children between the age of 1 month to less than 15 years, who are likely to stay in PICU for more than 48 hours, not being able to take food orally, enteral nutrition through naso gastric or oro gastric tube for mor than 4 days using standard food formula. |
|
| ExclusionCriteria |
| Details |
1.Children with altered Nasogastric tube aspirate
2.Children with enterocolitis
3.Children with surgical abdomen
4.Children with skull base injury.
5.Children with short bowel syndrome
6.Expected death within 24 hours
7. Readmission to PICU more than 48 hours after already having been included in the CONVINCE trial.
8) Transfer from another PICU after stay of more than or equal to 3 days or having received enteral nutrition |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To find the time taken(in days/hours) to reach target calorie (≥70% of calculated calories as per WHO age sex equation after initiation of feeds) and target protein of 1.5 g/kg/day. |
Until 1 week of initiation of enteral tube feeding. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To find out the incidence of feeding intolerance,glucose variability Hypoglycemia less than 60gm per dl and hyperglycemia more than 180 mg per dl
2. Incidence and cause of feeding interruption
3. 28 days mortality. |
1. To find out the incidence of feeding intolerance,glucose variability Hypoglycemia less than 60gm per dl and hyperglycemia more than 180 mg per dl
2. Incidence and cause of feeding interruption
3. 28 days mortality. |
|
|
Target Sample Size
|
Total Sample Size="146"
Sample Size from India="146"
Final Enrollment numbers achieved (Total)= "154"
Final Enrollment numbers achieved (India)="154" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| Date of Study Completion (India) |
14/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
14/11/2025 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
After receiving
written informed consent, all critically ill children who meet the inclusion
criteria and are admitted to the PICU of AIIMS Raipur, aged between 1 month and
≤ 15 years, will be enrolled in the study. Following enrollment, participants
will be randomly assigned to one of the two groups: Group A or Group B. Using WHO
reference charts (11), target protein and calorie requirements will be
calculated for both groups. Subjects in group A will receive continuous enteral
naso-gastric feeding via syringe pump over 24 hours, with a interruption of
maximum 2 hours. Subjects in group B will receive intermittent bolus enteral tube
feedings every three hourly as supplied by department of dietics,AIIMS Raipur. Enrolled subjects in the trial who
are readmitted to the PICU within 48 hours of being discharged and who are
still inside the original 7-day randomization window will be continued on the same
nutritional method to which they were initially randomly allocated during their
PICU stay.Enrolled children are followed up telephonically at
28 day post discharge to know the status of child.
|