PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Sun, 26 Sep 2021 06:23:49 GMT)

CTRI Number CTRI/2020/01/022674 [Registered on: 09/01/2020] - Trial Registered Prospectively Last Modified On 08/01/2020 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Preventive Behavioral Study Design Randomized, Parallel Group Trial Public Title of Study Educating Mothers regarding technique of breastfeeding and assessment of exclusive breastfeeding Scientific Title of Assessment of videobased educational intervention on breastfeeding technique in primigravida Study mother’s and it’s effect on early infant feeding pattern -Randomised controlled trial Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Pooja G Trial Coordinator (multi-center study) Designation Junior Resident Pediatrics Affiliation Manipal Academy of higher education Address Kasturba Medical college 203,lighthouse hill road Hampankatta Department of Pediatrics,Junior Resident . Kasturba Medical college 203,lighthouse hill road Hampankatta Mangalore Karnataka. Dakshina KARNATAKA 575001 Phone 7411511507 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Nutan Kamath Query) Designation Associate Dean and Professor of Pediatrics Affiliation Kasturba Medical college Mangalore Manipal Academy of higher education Address Dr Nutan Kamath Associate Dean Kasturba Medical college 203,lighthouse hill road Hampankatta Mangalore Karnataka. Kasturba Medical college 203,lighthouse hill road Hampankatta Mangalore Karnataka. KARNATAKA 575001 India Phone 9448147687 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Nutan Kamath Designation Associate Dean and Professor of Pediatrics Affiliation Kasturba Medical college Mangalore Manipal Academy of higher education

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Address Dr Nutan Kamath Associate Dean Kasturba Medical college 203,lighthouse hill road Hampankatta Mangalore Karnataka. Kasturba Medical college 203,lighthouse hill road Hampankatta Mangalore Karnataka. Dakshina Kannada KARNATAKA 575001 India Phone 9448147687 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Ladygoschen hospital affliliated to Kasturba Medical College Mangalore Primary Sponsor Primary Sponsor Details Name Pooja Address Dr Pooja Pediatric Resident 203 Lighthouse hill road Hampankatta,Mangalore Kasturba Medical college Mangaluru Type of Sponsor Other [nil] Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Medical Superindent Dr Pooja Lady Goschen Department of 9448869629 Hospital Pediatrics and Antenatal wards in poojagovind1995@gma Department of il.com Obstetrics and Gynecology 1st floor.Mangalore 575001 Dakshina Kannada KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional ethics Approved 16/10/2019 No committee Kasturba medical college,Mangaluru Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium Patients Pregnancy, childbirth and the puerperium Intervention / Type Name Details Comparator Agent Intervention Videobased Educational Educational video of 2min Intervention about breastfeeding 20sec duration in kannada technique and its effect on early language regarding technique of infant feeding pattern both in breastfeeding global health study and IEC education for media project video

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control group Comparator Agent IEC Education regarding IEC education and flipcharts breastfeeding provided by Govt of karanataka Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 40.00 Year(s) Gender Female Details 1)Primigravida Mothers above 18years of age,with no high risk factors(Pre-eclampsia and eclampsia,uncontrolled sugar with hba1c>6.5%,uncompensated cardiovascular disease with NYHA Grade3 and above)admiited for safe confinement and not in labour
2)Literate in Kannada. Exclusion Criteria Exclusion Criteria Details 1)Multiple Pregnancy 2)Mothers not willing exclusively to breastfeed their infants for 6 months. 3)Infants with Orofacial Malformations(cleftlip,cleftlip) 4)Mothers who are not able to breastfeed with in 48hours of delivery(Infants admitted in Nicu and MOthers admitted in Intensive care unit.) 5)Mothers previously educated with video on breastfeeding technique 6)Primary Lactation failure Method of Generating Permuted block randomization, variable Random Sequence Method of Sequentially numbered, sealed, opaque envelopes Concealment Blinding/Masking Double Blind Double Dummy Primary Outcome Outcome Timepoints Effect of antenatal video education intervention Effect of antenatal video education intervention on breastfeeding technique and re-enforcement on breastfeeding technique and re-enforcement in early puerperium in primigravida mothers on in early puerperium in primigravida mothers on exclusive breastfeeding rate shortterm at 2 exclusive breastfeeding rate shortterm at 2 months and longterm at 6 months months and longterm at 6 months Secondary Outcome Outcome Timepoints Followup telephone survey at 2,4 and 6 months 2,4 and 6 months after delivery ,to assess the infant feeding practices (EBF,PBF and CBF) Target Sample Size Total Sample Size=64 Sample Size from India=64 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 07/11/2019 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=3 Trial Months=1 Days=10 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India)

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Publication Details not applicable Brief Summary This study is a video based intervention educating mothers regarding technique of breastfeeding and assessing infant feeding pattern telephonically at 2,4 and 6 months.

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