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CTRI Number  CTRI/2021/09/036791 [Registered on: 23/09/2021] Trial Registered Prospectively
Last Modified On: 13/11/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Practical new approach for restarting breastfeeding in newborns and infants who have stopped breastfeeding done in a private pediatric medical practice 
Scientific Title of Study   Newer intervention strategy for successful relactation of newborns and infants in private practice 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Selvan Rathinasamy 
Designation  Child Health Consultant 
Affiliation  Lotus Hospital and Research Centre Limited 
Address  Department of Pediatrics,child health division,Room number 236,Lotus Hospital and Research Centre Limited Poondurai Road Erode
Poondurai Road Erode
Erode
TAMIL NADU
638002
India 
Phone  9442836613  
Fax    
Email  selvanr4@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Selvan Rathinasamy 
Designation  Child Health Consultant 
Affiliation  Lotus Hospital and Research Centre Limited 
Address  Department of Pediatrics,child health centre,Room number 236,Lotus Hospital and Research Centre Limited Poondurai Road Erode
Poondurai Road Erode
Erode
TAMIL NADU
638002
India 
Phone  9442836613  
Fax    
Email  selvanr4@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Selvan Rathinasamy 
Designation  Child Health Consultant 
Affiliation  Lotus Hospital and Research Centre Limited 
Address  Department of Pediatrics,child health centre,Room number 236,Lotus Hospital and Research Centre Limited Poondurai Road Erode
Poondurai Road Erode
Erode
TAMIL NADU
638002
India 
Phone  9442836613  
Fax    
Email  selvanr4@yahoo.com  
 
Source of Monetary or Material Support  
Lotus Hospital and Research Centre Limited 
 
Primary Sponsor  
Name  Dr Selvan Rathinasamy 
Address  Lotus Hospital and Research centre Limited Poondurai Road Erode 
Type of Sponsor  Other [Private Practitioner] 
 
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 Selvan Rathinasamy  Lotus Hospital and Research Centre Limited  Department of Pediatrics,child health centre,Room number 236,Lotus Hospital and Research Centre Limited Poondurai Road Erode
Erode
TAMIL NADU 		 9442836613

selvanr4@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Erode cancer centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P929||Feeding problem of newborn, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1.The newborn or infant and mother dyad who have low milk supply
2.The newborns or infant and mother dyad who have partial or total lactation failure
3.The newborns or infant and mother dyad who are willing for relactation or advised relactation 
 
ExclusionCriteria 
Details  1. Mothers with systemic illness and on medications which are contraindicated in lactation
2.Babies who had severe birth problems, congenital, genetic and chromosomal anomalies 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Increase in the milk supply,adequete weight gain and successful relactation  Day 7
day 14
day 45
day 105
day 180 
 
Secondary Outcome  
Outcome  TimePoints 
Educational videos contribution in helping mothers breastfeeding and reducing relactation failure rate  Day 7
day 14
day 45
day 105
day 180 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   28/09/2021 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [selvanr4@yahoo.com].

  6. For how long will this data be available start date provided 13-09-2022 and end date provided 12-09-2025?
    Response (Others) -  3 YRS after the completion of the study

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

To study the effectiveness of the newer intervention  strategy using breastfeeding educational videos (Produced by the global health media Ltd and IIT mumbai)  and find out their effectiveness in improving the breastfeeding success rate ,adequate milk transfer and successful relactation of newborns and infants. This prospective observational study will done at the Pediatric clinic after obtaining informed consent. The details will be collected through breastfeeding questionnaire and B-R-E-A-S-T feeding observation form and interviews. Additional details on family support, reasons for stopping breastfeeding  relactation and job pressures  will be collected. Mother and baby dyad fulfilling the inclusion criteria will be entered in the study . Breastfeeding educational videos by Global health media limited and IIT mumbai (in Tamil) will be shown and correct technique will be taught. A personal copy will be shared with the parents. Skilled trained staffs under the supervision of principal investigator will be assessing and counselling them. The primary outcome will be initiation of relactation, increase in milk supply . The secondary outcome will be the educational video’s contribution in reducing relactation failure rate and improving the success rate. Mother and infant dyads will be followed up at 7th, 14 th, 45 th, 105 and 180 days of baby’s life during follow up and vaccination visits. If visits are not possible telephonic follow up  focusing on the status of relactation enquired . Positive emotional and psychological support will be provided .SPSS statistical software version 25 will be used to analyze the data. Logistic regression will be calculated to assess the odds ratio promoting success and p value of less than 0.05 will be considered significant

 
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