| CTRI Number |
CTRI/2021/06/034299 [Registered on: 18/06/2021] Trial Registered Prospectively |
| Last Modified On: |
16/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Mixed Method(quantitative and qualitative) |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the information,thoughts and preventing reasons for human milk banking among the people who receive care and who are involved in providing care at AIIMS,New Delhi and based on this to develop a video to sensitize regarding the same |
|
Scientific Title of Study
|
A study to assess the knowledge,attitude and perceived barriers regarding Human Milk Banking among stakeholders of healthcare at AIIMS, New Delhi with a view to develop an e-educational material |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Noor Teresa Fudong |
| Designation |
MSc.Nursing Student |
| Affiliation |
AIIMS,New Delhi |
| Address |
College of Nursing,
AIIMS
New Delhi
DELHI
110029
India |
| Phone |
09597349583 |
| Fax |
|
| Email |
fudonggal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Cecilia Mary |
| Designation |
Associate Professor and Guide |
| Affiliation |
AIIMS,New Delhi |
| Address |
College of Nursing,
AIIMS
New Delhi
DELHI
110029
India |
| Phone |
9899187056 |
| Fax |
|
| Email |
cecilia.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Cecilia Mary |
| Designation |
Associate Professor and Guide |
| Affiliation |
AIIMS,New Delhi |
| Address |
College of Nursing,
AIIMS
New Delhi
DELHI
110029
India |
| Phone |
9899187056 |
| Fax |
|
| Email |
cecilia.aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
Noor Teresa Fudong |
| Address |
College of Nursing,
AIIMS, New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Noor Teresa Fudong |
AIIMS,New Delhi |
Department of Pediatrics( NICU and pediatric wards), Department of Obstetrics and Gynecology(Antenatal clinic,Labour Room, Postnatal wards)
New Delhi
DELHI |
09597349583
fudonggal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nurses,doctors working in Pediatric, Obstetrics and gynecology department and nursing students studying at AIIMS, New Delhi |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Antenatal mothers coming to the antenatal clinic,postnatal mothers admitted in labour room and wards,nurses and doctors working in Pediatrics ,Obstetrics and Gynaecology Department at AIIMS, New Delhi and the undergraduate/postgraduate nursing students pursuing their studies at AIIMS, New Delhi |
|
| ExclusionCriteria |
| Details |
Individuals who are unwilling to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the knowledge, attitude and perceived barriers regarding Human milk banking among recipients of healthcare(antenatal and postnatal mothers)
To assess the knowledge, attitude and perceived barriers regarding Human Milk banking among nurses, doctors, undergraduate and postgraduate nursing students. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To develop an e-educational material |
1 year |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
21/06/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a mixed method study conducted among stakeholders of healthcare (antenatal and postnatal mothers, the nurses, doctors and nursing students) to assess their knowledge, attitude and perceived barriers regarding human milk banking. The data will be collected both quantitatively and qualitatively. The data assessing the knowledge will be acquired through a questionnaire, the attitude by a 5 point Likert scale and the perceived barriers through open ended questions. Convenient sampling technique will be used to collect the data. The study also aims to develop an educational material regarding human milk banking to be available online. |