| CTRI Number |
CTRI/2023/11/059526 [Registered on: 03/11/2023] Trial Registered Prospectively |
| Last Modified On: |
07/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Identifying feeding problems in normal children between 1-5 years |
|
Scientific Title of Study
|
Estimating the prevalence of feeding problems in typically developing children between 1-5 years |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vyshnavi N K |
| Designation |
Post Graduate |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing
Manipal College of Health Professions, MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
9995271404 |
| Fax |
|
| Email |
vyshnavi.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Vyshnavi N K |
| Designation |
Post Graduate |
| Affiliation |
PhD |
| Address |
Department of Speech and Hearing
Manipal College of Health Professions, MAHE
Department of Speech and Hearing
Manipal College of Health Professions, MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
9995271404 |
| Fax |
|
| Email |
usha.d@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Vyshnavi N K |
| Designation |
Post Graduate |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing
Manipal College of Health Professions, MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
9995271404 |
| Fax |
|
| Email |
vyshnavi.mchpmpl2022@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Speech and Hearing, MCHP, MAHE |
|
|
Primary Sponsor
|
| Name |
Vyshnavi N K |
| Address |
Department of Speech and Hearing
Manipal College of Health Professions, MAHE |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Vyshnavi N K |
Manipal College of Health Professions |
Department of Speech and Hearing
Manipal College of Health Professions, MAHE
Udupi
KARNATAKA |
9995271404
vyshnavi.mchpmpl2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
feeding problems |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Typically Developing Children based on ICF checklist (screening) between the ages of 1-5 years |
|
| ExclusionCriteria |
| Details |
Premature children (<37 weeks)
Children with a history of neurodegenerative disease and cleft lip and palate
Children who are still on breast feeding |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To estimate the prevalence of feeding problems in typically developing children between 1 to 5 years
|
32 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the relationship between demographic and anthropometric factors with feeding problems in typically developing children |
32 weeks |
|
|
Target Sample Size
|
Total Sample Size="288"
Sample Size from India="288"
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)
|
09/09/2024 |
| 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="0"
Months="10"
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
|
Need for the study: Feeding problems can affect the child’s wholistic development, and most of the studies related to feeding problems in typically developing children were done in western population. Thus, there is need to identify the feeding problems experienced by TDC and prevent feeding problem related consequence by educating the parents.Aim: Estimating the prevalence of feeding problems in typically developing young children between 1 to 5 years. Objectives: To estimate the prevalence of feeding problems in typically developing children between 1 to 5 years. To determine the relationship between demographic and anthropometric factors with feeding problems in TDC. |