| CTRI Number |
CTRI/2024/05/066920 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive Process of Care Changes Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Improving exclusive breastfeeding through effective interventional counselling in an immunisation clinic in a tertiary hospital |
|
Scientific Title of Study
|
Improving exclusive breastfeeding through effective interventional counselling in an immunisation clinic in a tertiary hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudiksha Gupta |
| Designation |
Final year MBBS student |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Old S Chandrashekhar hostel, KMC campus,
Manipal, Udupi
Udupi KARNATAKA 576104 India |
| Phone |
7982409646 |
| Fax |
|
| Email |
educatesudiksha@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shruthi Kumar Bharadwaj |
| Designation |
Assistant professor, Department of Neonatology, Kasturba Hospital, |
| Affiliation |
Kasturba Hospital |
| Address |
Dr. Shruthi Kumar Bharadwaj
Assistant Professor, Neonatology
Kasturba Medical College and Hospital
Madhav Nagar, Manipal
Karnataka 576104
Udupi KARNATAKA 576104 India |
| Phone |
7982409646 |
| Fax |
|
| Email |
shruthi.kb@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr. Shruthi Kumar Bharadwaj |
| Designation |
Assistant professor, Department of Neonatology, Kasturba Hospital, |
| Affiliation |
Kasturba Hospital |
| Address |
Dr. Shruthi Kumar Bharadwaj
Assistant Professor, Neonatology
Kasturba Medical College and Hospital
Madhav Nagar, Manipal
Karnataka 576104
Udupi KARNATAKA 576104 India |
| Phone |
7982409646 |
| Fax |
|
| Email |
shruthi.kb@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital
Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka
576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital |
| Address |
Kasturba Medical College and Hospital
Madhav Nagar, Manipal
Karnataka 576104 |
| Type of Sponsor |
Private medical college |
|
|
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 Shruthi Bharadwaj |
Kasturba Medical College and Hospital |
Immunisation Clinic, Mother and Child block
Kasturba Medical College and Hospital
Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104 Udupi KARNATAKA |
7338321832
shruthi.kb@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 |
Infants on breastfeeding within 6 months of age |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Educational counselling using audio visual materials |
Videos, educational pamphlet, counselling in local language and follow up
Done for the first time at first visit to immunisation clinic at age 6-8 weeks of infant, followed by each subsequent visit back for a 6 month duration according to Kasturba Hopsitals immunisation schedule (approximately 4 visits) |
| Comparator Agent |
Standard verbal counseling |
regular lactation counselling done in the hospital just after birth and during normal newborn check-ups as per their respective Doctors orders
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Day(s) |
| Age To |
7.00 Month(s) |
| Gender |
Both |
| Details |
The study groups consist of clinically stable mother-infant pair seen at the
immunization clinic at 6-8 weeks of age |
|
| ExclusionCriteria |
| Details |
Infants who were born preterm
Congenital anomalies
Chromosomal anomalies
Surgical conditions, if any
Not given consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
a)comparative difference in rates of exclusive breast feeding between two groups
|
Assessed at the end of the 6 month follow up of both cohorts |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
b) comparative difference in rates of infection (ARI and ADD) between two groups
|
6 months of age |
| c) Barriers to exclusive breastfeeding |
6 months of age |
|
|
Target Sample Size
|
Total Sample Size="160" Sample Size from India="160"
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)
|
15/05/2024 |
| 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="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
|
The study will be conducted in the Department of Neonatology and Pediatrics, Kasturba Hospital, Manipal, India. All mother-infant pairs who visit the immunization clinic at 6-8 weeks of age will be screened for eligibility. After obtaining written informed consent, those who fulfil the inclusion criteria will be included in the study. Demographic details like antenatal, birth history, feeding history, type of feeding (direct breastfeeding, expressed breastmilk, formula, or combined), and problems faced with feeding (maternal and infant related) will be noted. Breastfeeding habits will be assessed with a standard questionnaire. The mother-infant pair fulfilling the inclusion criteria will be counselled with standard counselling (Cohort 1) for the first three months of the study. In the next three months, they will be counselled using educational interventional counselling (Cohort 2). Infants in cohort 1 will receive regular standard verbal counselling per hospital protocol. Infants in cohort 2 will receive a standard educational interventional counselling session, including breastfeeding videos, brochures, pamphlets, etc. (all resources attached in a separate document titled- RESOURCES). Infants in both cohorts will be followed up in the immunization clinic at six months of age. Those who could not visit at six months of age will be contacted over the telephone. Data on breastfeeding practices, infections ( diagnosis and treatment/ recurrence of any diarrhoea, cough, Acute Respiratory Infections, pneumonia, meningitis, etc., at a clinic or hospital), noncompliance, and problems mothers face in feeding or discontinuing exclusive breastfeeding before six months of age will be documented via a proforma. After validation, a standard breastfeeding assessment questionnaire will be prepared from pre-existing formats and applied to all Mother-Infant pairs. This questionnaire will assess feeding habits, barriers to feeding, and well-being of mother-infant pairs. |