| CTRI Number |
CTRI/2021/04/033098 [Registered on: 26/04/2021] Trial Registered Prospectively |
| Last Modified On: |
23/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative Descriptive Design |
| Study Design |
Other |
|
Public Title of Study
|
Experience of mother providing kangaroo mother care (KMC) to their low birth weight(LBW) newborn in selected hospital of India |
|
Scientific Title of Study
|
A qualitative study on experience of mother providing kangaroo mother care (KMC) to their low birth weight(LBW) newborn in selected hospital of India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arpita Bandyopadhyay |
| Designation |
Clinical Instructor |
| Affiliation |
College of Nursing R G Kar Medical College & Hospital |
| Address |
College of Nursing Academy building 6th floor R G Kar Medical College And Hospital Kolkata West Bengal Kolkata 700004
Kolkata
WEST BENGAL
700004
India |
| Phone |
9830132109 |
| Fax |
|
| Email |
iiarpita.bandyopadhyay.ab@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamatha Shivananda Pai |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing Manipal Academy of Higher Education Manipal Karnataka |
| Address |
Manipal College of Nursing Manipal Academy of Higher Education
Manipal Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9448623789 |
| Fax |
|
| Email |
mamatha.spai@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamatha Shivananda Pai |
| Designation |
Professor |
| Affiliation |
Manipal College of Nursing Manipal Academy of Higher Education Manipal Karnataka |
| Address |
Manipal College of Nursing Manipal Academy of Higher Education
Manipal Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9448623789 |
| Fax |
|
| Email |
mamatha.spai@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Arpita Bandyopadhyay
Primary investigator
6th floor Academy Building College of Nursing RG Kar MCH Kolkata 700004
|
| IPGME&R SSKM Hospital
Kolkata 700020 West Bengal |
| RG Kar Medical College & Hospital Kolkata 700004
West Bengal |
|
|
Primary Sponsor
|
| Name |
Primary Investigator Arpita Bandyopadhyay |
| Address |
E 103 Basundhara Apartment 616 Mahamayatala Road Kolkata 700084
College of Nursing RG Kar MCH Kolkata
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Arpita Bandyopadhyay |
SNCU IPGME&R SSKM HOSPITAL |
SNCU 2nd and 3rd floor Neonatology Department IPGME&R SSKM Hospital Kolkata 20
Kolkata
WEST BENGAL |
9830132109
iiarpita.bandyopadhyay.ab@gmail.com |
| Arpita Bandyopadhyay |
SNCU RG KAR Medical College and Hospital |
SNCU Neonatal Care Unit 1st Floor RG Kar Medical College And Hospital 1 Khudiram Bose Sarani Kolkata 700004
Kolkata
WEST BENGAL |
9830132109
iiarpita.bandyopadhyay.ab@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kasturba Medical College and Kasturba Hospital |
Approved |
| Institutional Ethics Committee R G Kar Hospital |
Approved |
| IPGME and R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Mother of stable LBW new-born Who are advised for Kangaroo mother care, weighing between 1000 grams to 2499 grams.
Mother who is aged above 18 years & who can speak and understand Bengali.
Mother who is willing to participate in the study and who will give written consent.
Mother who is providing Kangaroo Mother Care to their Low Birth Weight new-born at least 5 hours in a day on an average.
Mother who is giving KMC to their newborn for ten (10) days after the birth.
|
|
| ExclusionCriteria |
| Details |
Mother with auditory impairment or is diagnosed with any psychiatric illness.
Mother who is unwilling to participate in the study.
Non-biological mother.
Mother of Low Birth Weight newborn with congenital anomaly or genetic disorder.
Mother of Extremely Low Birth Weight (ELBW) newborn
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To provide rich description of the experience of the mother providing Kangaroo Mother Care to their Low Birth Weight new born in selected hospital of India |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/05/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- 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
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [iiarpita.bandyopadhyay.ab@gmail.com].
- For how long will this data be available start date provided 01-04-2022 and end date provided 01-04-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Not applicable |