| CTRI Number |
CTRI/2024/03/063496 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of growth and nutritional status of babies 0-3 months of age undergoing enterostomy |
|
Scientific Title of Study
|
Assessment of somatic growth and nutritional status of infants 0-3 months of age undergoing enterostomy: a prospective study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kaashvi Udwani |
| Designation |
senior resident |
| Affiliation |
Post Graduate institute of medical education and research(PGIMER), Chandigarh |
| Address |
Department of pediatric surgery, Advanced pediatric centre, Post Graduate institute of medical education and research(PGIMER), Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8980120439 |
| Fax |
|
| Email |
kaashvi.udwani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shivani Dogra |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Reseach(PGIMER), Chandigarh |
| Address |
Department of pediatric surgery, Advanced pediatric centre, Post Graduate Institute of Medical Education and Research(PGIMER), Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9654217383 |
| Fax |
|
| Email |
shivanidogra2003@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Kaashvi Udwani |
| Designation |
senior resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research(PGIMER), Chandigarh |
| Address |
Department of pediatric surgery, Advanced pediatric centre,Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8980120439 |
| Fax |
|
| Email |
kaashvi.udwani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh |
|
|
Primary Sponsor
|
| Name |
Kaashvi Udwani |
| Address |
Department of pediatric surgery,Advanced Pediatric Centre, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR MUNEER MALIK |
Department of pediatric surgery,Advancd Pediatric Centre PGIMER, Chandigarh |
| DR NITIN PETERS |
Department of pediatric surgery,Advancd Pediatric Centre PGIMER, Chandigarh |
| DR SAILESH SOLANKI |
Department of pediatric surgery,Advancd Pediatric Centre PGIMER, Chandigarh |
| DR SHIVANI DOGRA |
Department of pediatric surgery,Advancd Pediatric Centre PGIMER, Chandigarh |
| PROF JK MAHAJAN |
Department of pediatric surgery,Advancd Pediatric Centre PGIMER, Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kaashvi udwani |
Department of Pediatric surgery,Post Graduate Institute of Medical Education and Research(PGIMER) |
Dept of Pediatric Surgery,Advanced Pediatric Centre, Post Graduate Institute of Medical Education and Research(PGIMER), Sector 12, Chandigarh
Chandigarh
CHANDIGARH |
8980120439
kaashvi.udwani@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: K638||Other specified diseases of intestine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
3.00 Month(s) |
| Gender |
Both |
| Details |
Neonates undergoing excretory enterostomy.
Infants less than 3 months undergoing excretory enterostomy. |
|
| ExclusionCriteria |
| Details |
Children with complex cardiac disorders.
Children with Suspected syndromes or Aneuploidy
Children in whom parental consent is not available |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess somatic growth in neonates undergoing enterostomy by means
of the following parameters
Weight,Length,Head circumference |
at diacharge, 1 month, 3 month, 6 month follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess:
1. Micronutrient deficiencies
2. Electrolyte disturbances
3. Correlation of growth failure with length of proximal gut
4. Incidence of hypoproteinemia |
at discharge,1 month, 3 month, 6 month follow up |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
11/03/2024 |
| 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 Yet Recruiting |
| 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
|
This study aims to assess the somatic growth and nutritional status of neonates and infants less than 3 months of age with who underwent enterostomy . The primary aim - To assess somatic growth in neonates undergoing enterostomy by means of the following parameters 1. Weight 2. Length 3. Head circumference The secondary aim - To assess: 1. Micronutrient deficiencies 2. Electrolyte disturbances 3. Correlation of growth failure with length of proximal gut 4. Incidence of hypoproteinemia
This is a prospective study and will be conducted in Department of Pediatric Surgery, PGIMER from May 2023 to December 2024 Details of the study Study location: Department of Pediatric Surgery, PGIMER, Chandigarh Study population: Patients less the 3 months of age undergoing abdominal enterostomy (/jejunostomy/ileostomy/ colostomy). These will be divided into 2 groups – ileostomy/jejunostomy group and colostomy group Sample size: A sample size of 150 patients will be taken. Each patient will be allocated to one of these 2 groups – ileostomy/jejunostomy or colostomy. 50 patients will be taken in each group. Same number of controls will be taken from the infants less than 3 months coming to OPD/ward for issues unrelated to gastrointestinal tract.
Method of collection of data: A detailed proforma will be filled up for each of the assessment parameters • At discharge • At 1 month follow up • At 3 month follow up • At 6 month follow up (earlier if stoma closure planned early) Anthropometric parameters: • Weight for age • Length for age • Weight for Length • Head circumference for age
Parameters to be seen at discharge and at 6 month follow up (earlier if stoma closure planned early): 1. Serum calcium 2. Serum phosphorus 3. Serum alkaline phosphate 4. Hemoglobin and iron studies 5. Serum magnesium 6. Total protein/ albumin 7. TFT(T3/T4/TSH) Parameters to be seen at 6 month follow up (earlier if stoma closure planned early): 1. Micronutrients - copper and zinc 2. Serum triglyceride levels 3. Serum vitamin b12 4. Serum vitamin D 5. Serum folate Parameters to be seen at discharge, at 1 month follow up, at 3 month followup, 6 month follow up (earlier if stoma closure planned early) 1. Serum and urinary sodium 2. Serum potassium |