| CTRI Number |
CTRI/2025/07/090076 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Why some women fail to exclusively breastfeed their infants |
|
Scientific Title of Study
|
Incidence and factors associated with failure to exclusively breastfeed before six months in mothers delivered at a tertiary care hospital- A Longitudinal cohort 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 |
Aashna Shiraz |
| Designation |
Postgraduate trainee |
| Affiliation |
Ramakrishna Mission Seva Pratishthan |
| Address |
Department of Paediatrics, 2nd floor, Ramakrishna Mission Seva Pratishthan, Vivekananda Institute of Medical Sciences, Kolkata
Kolkata
WEST BENGAL
700026
India |
| Phone |
9748931152 |
| Fax |
|
| Email |
aashnashiraz001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Braja Gopal Ray |
| Designation |
Associate Professor |
| Affiliation |
Ramakrishna Mission Seva Pratishthan |
| Address |
Dept. Of Paediatrics, Ramakrishna Mission Seva Pratishthan, Vivekananda Institute of Medical Sciences, Kolkata
Kolkata
WEST BENGAL
700026
India |
| Phone |
9748931152 |
| Fax |
|
| Email |
brajaray@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aashna Shiraz |
| Designation |
Postgraduate trainee |
| Affiliation |
Ramakrishna Mission Seva Pratishthan |
| Address |
Dept. of Paediatrics, 2nd Floor Ramakrishna Mission Seva Pratishthan, Vivekananda Institute of Medical Sciences, Kolkata
Kolkata
WEST BENGAL
700026
India |
| Phone |
9748931152 |
| Fax |
|
| Email |
aashnashiraz001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ramakrishna Mission Seva Pratishthan, Vivekananda Institute of Medical Sciences, 99 Sarat Bose Road, Kolkata, Pin- 700026 |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable ] |
|
|
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 Aashna Shiraz |
RAMAKRISHNA MISSION SEVA PRATISHTHAN, VIVEKANANDA INSTITUTE OF MEDICAL SCIENCES |
Postnatal ward, Well Baby Clinic, Immunisation Clinic, RAMAKRISHNA MISSION SEVA PRATISHTHAN, VIVEKANANDA INSTITUTE OF MEDICAL SCIENCES, KOLKATA- 26
Kolkata
WEST BENGAL |
9748931152
aashnashiraz001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RAMAKRISHNA MISSION SEVA PRATISHTHAN VIVEKANANDA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All mothers who delivered in Ramakrishna Mission Seva Pratishthan, Kolkata- 26 |
|
|
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 |
All mothers who delivered at Ramakrishna Mission Seva Pratishthan, Kolkata- 26 |
|
| ExclusionCriteria |
| Details |
1. Mothers of outborn babies. 2. Mothers’ death. 3. Mother on medication that is absolutely contradicted in breastfeeding. 4. Mothers of babies having severe congenital anomalies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
(Descriptive) Estimating the incidence of failure of exclusive breastfeeding (defined) by the mothers who delivered babies at Ramakrishna Mission Seva Pratishthan by 6 months after delivery.
(Analytical) Determine the factors which are associated with the discontinuation of exclusive breast feeding at 6 months compared to mothers who continue exclusive breast feeding till 6 months |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To build a predictive risk model based on the data collected to identify mothers who are more likely to stop exclusive breastfeeding before 6 months |
18 months |
|
|
Target Sample Size
|
Total Sample Size="1067"
Sample Size from India="1067"
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)
|
30/08/2025 |
| 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="6"
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
|
Lack of exclusive breastfeeding is associated with infant and childhood morbidity and mortality including lifelong impact on school performance, productivity, and intellectual development, and overall health during adolescence and adulthood. Breastfeeding in general, exclusive breastfeeding in particular, is among the best interventions in the first 1000 days. The main challenges impeding the success of breastfeeding were: formal work schedule;informal work; family influence due to community culture from grandmothers, cousins, and aunties; insufficient breast milk; and swollen breast or sore
nipples. The literature revealed that the initiation rate of breastfeeding is high. However, the ratedeclined over six months. Aim of this study is to estimate the prevalence of cessation of exclusive breastfeeding (defined) by the mothers who delivered babies at a tertiary care hospital, at 6 months after delivery determine the factors which are associated with the discontinuation of exclusive breast feeding at 6 months compared to mothers who continue exclusive breast feeding at 6
months. Based on our study, we can create a prediction risk model where we can identify mothers who will probably stop breastfeeding or will not continue exclusive breastfeeding. Thus, we can counsel those mothers and increase the incidence of exclusive breastfeeding, which shall benefit our society. |