| CTRI Number |
CTRI/2024/07/070490 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The barriers to Exclusive Breast Feeding for mothers. |
|
Scientific Title of Study
|
A study to assess the barriers to Exclusive Breast Feeding for mothers in selected hospitals of Udupi district. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Helena Maria Prasad |
| Designation |
Undergraduate student |
| Affiliation |
Manipal College of Nursing MCON MAHE |
| Address |
Manipal College of Nursing Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9744700398 |
| Fax |
|
| Email |
helena.prasad@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maria Pais |
| Designation |
Assistant Professor- Senior Scale |
| Affiliation |
Manipal College of Nursing MAHE |
| Address |
Department of Obstetrical and Gynaecological Nursing 3rd floor Manipal College of Nursing, Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9880873560 |
| Fax |
|
| Email |
maria.v@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Laveena Anitha Barboza |
| Designation |
Lecturer |
| Affiliation |
Manipal College of Nursing MAHE |
| Address |
Department of Fundamentals of Nursing 3rd floor Manipal College of Nursing Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9743856087 |
| Fax |
|
| Email |
barboza.laveena@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Nursing |
|
|
Primary Sponsor
|
| Name |
Helena Maria Prasad |
| Address |
Manipal College of Nursing Manipal Academy of Higher Education Manipal
pin code: 576104
Karnataka India |
| 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 |
| Dr Maria Pais |
Kasturba Medical College Manipal |
Department of paediatrics, divison of neonatology medicine
Udupi
KARNATAKA |
09880873560
maria.v@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mothers with children who are of 6 months and below. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
6.00 Month(s) |
| Gender |
Both |
| Details |
Mothers of children who are 6 months and below who is willing to participate in the study, who can read and write kannada. |
|
| ExclusionCriteria |
| Details |
Those who are not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To ascertain the prevalence of EBF practices in the selected hospitals in the Udupi district assess the traits associated with those practices and pinpoint obstacles to the EBF practices. |
At the time of admission and outpatient services. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To understand the difficulties & other reasons that affects mother form withholding EBF |
At a time period from birth to 6 months of the child |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
22/07/2024 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Title of the project: A study to assess the barriers to Exclusive Breast Feeding for mothers in selected hospitals of Udupi District. Purpose of the study: The purpose of this study is to ascertain the prevalence of EBF practices in the selected hospitals of Udupi District, assess the traits associated with those practices and pinpoint obstacles to EBF practices. Objectives of the study are: a) to estimate the prevalence of Exclusive Breast Feeding among postnatal mothers of Udupi District b) to assess the barriers associated with Exclusive Breast Feeding among mothers by using a structured questionnaire. |