| CTRI Number |
CTRI/2022/01/039853 [Registered on: 31/01/2022] Trial Registered Prospectively |
| Last Modified On: |
17/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To determine the knowledge and attitude related to breastmilk donation among mothers visiting the hospitals of Chennai city, Tamilnadu. |
|
Scientific Title of Study
|
Assessment of knowledge and attitude regarding human milk donation among postnatal women visiting tertiary care hospitals of Chennai city, Tamilnadu |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashika BG |
| Designation |
Student |
| Affiliation |
Prasanna school of public health, MAHE |
| Address |
Room No:61, Department of Health Policy, Prasanna school of Public Health,Madhav Nagar, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9003064303 |
| Fax |
|
| Email |
ashika.bg@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navya Vyas |
| Designation |
Associate Professor |
| Affiliation |
Prasanna school of public health, MAHE |
| Address |
Room No:62,Department of Health Policy, Prasanna school of Public Health, Madhav Nagar, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9538126121 |
| Fax |
|
| Email |
navya.vyas@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navya Vyas |
| Designation |
Associate Professor |
| Affiliation |
Prasanna school of public health, MAHE |
| Address |
Room No:62,Department of Health Policy, Prasanna school of Public Health, Madhav Nagar, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9538126121 |
| Fax |
|
| Email |
navya.vyas@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 VC Srinivas |
MIOT Hospitals |
Room No:30, Out Patient Division, Department of Pediatrics.
Kancheepuram
TAMIL NADU |
9962425225
shri4721@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MIOT Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Breastfeeding mothers |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Female |
| Details |
Postnatal women visiting the tertiary care hospitals and Women having child less than one year of age
|
|
| ExclusionCriteria |
| Details |
Mothers suffering from Mastitis, and infectious diseases like Hepatitis and HIV and Mothers who were critically ill
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| By assessing the knowledge and attitude towards human milk donation from postnatal women perspectives the reasons behind demand supply gap of human milk banks could be identified. |
4 Weeks after data collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The results can further help to take the necessary steps to increase the awareness and to frame the recommendations and suggestions regarding human milk donation. |
2 months after data collection |
|
|
Target Sample Size
|
Total Sample Size="380"
Sample Size from India="380"
Final Enrollment numbers achieved (Total)= "372"
Final Enrollment numbers achieved (India)="372" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2022 |
| Date of Study Completion (India) |
31/03/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="22"
Months="3"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Of the 15 million babies born preterm globally, 1/5th are born in India. Given that prematurity is the leading cause of death in children under five years across the globe, breast milk donation is endorsed and recommended as the first alternative when it is not possible for the mother to breastfeed their hospitalized babies or if their mothers do not have sufficient milk production and any other condition where mothers may not be able to feed their babies. India is a country with eighty operational human milk banks. The human milk banks of India have reported the demand-supply gap of human donor milk. A previous study have shown the limitation of Knowledge, Attitude, and practices towards Human milk banks as one of the significant research gaps. Understanding the factors influencing mothers regarding breast milk donation could lead to improved communication about donations to milk banks. In Tamilnadu one of its milk bank has played a vital role in raising the infant survival rate to 85 percent since 2015. Although Tamil Nadu is one of the states in India, having the highest number of milk banks,the donor remains limited due to the misconceptions and lack of awareness towards the donation.Therefore, this study will assess the knowledge and attitude regarding human milk donations among postnatal women visiting tertiary care hospitals of Chennai, Tamil Nadu and the factors influencing it which will further help to take the necessary steps to increase the awareness and to frame the recommendations and suggestions regarding huamn milk donation. |