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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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