| CTRI Number |
CTRI/2025/11/097761 [Registered on: 20/11/2025] Trial Registered Prospectively |
| Last Modified On: |
19/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Kangaroo Care that means skin to skin contact at Home vs Regular Care for Newborn Babies: A Study to See Which Helps Babies Grow Better |
|
Scientific Title of Study
|
Kangaroo Mother Care at Home vs. Routine Care in Healthy Neonates- A Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kanchankumar Bhagyawant |
| Designation |
Consultant Pediatrician |
| Affiliation |
Ruby Hall Clinic |
| Address |
Ruby Hall Clinic, 40, Sasson road, Pune
Ruby Hall Clinic, 40, Sasson road, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9860937972 |
| Fax |
|
| Email |
drkanchankumar@rubyhall.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kanchankumar Bhagyawant |
| Designation |
Consultant Pediatrician |
| Affiliation |
Ruby Hall Clinic |
| Address |
Ruby Hall Clinic, 40, sasson road, Pune
Ruby Hall Clinic, 40, sasson road, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
09860937972 |
| Fax |
|
| Email |
drkanchankumar@rubyhall.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kanchankumar BHhagyawant |
| Designation |
Consultant Pediatrician |
| Affiliation |
Ruby Hall Clinic |
| Address |
Ruby Hall Clinic, 40, Sasson road, Pune
Ruby Hall Clinic, 40, Sasson road, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
09860937972 |
| Fax |
|
| Email |
drkanchankumar@rubyhall.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Kanchankumar Bhagyawant |
| Address |
Ruby Hall Clinic, 40, Sassoon road, Pune |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DrKanchankumar Bhagyawant |
Ruby Hall Clinic |
Ruby Hall Clinic
40, Sassoon road, Pune
Pune
MAHARASHTRA |
9860937972
drkanchankumar@rubyhall.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| POONA MEDICAL RESEARCH FOUNDATION INSTITUTIONA ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY NEWBORNS |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KANGAROO MOTHER CARE AT HOME |
Mothers will receive hands-on training on KMC before discharge.
KMC is to be done at least 1 hour daily for 4 weeks.
Daily logs and weekly telephonic follow-up for compliance and support.
|
| Comparator Agent |
ROUTINE CARE |
Standard postnatal care advice without emphasis on KMC |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Month(s) |
| Gender |
Both |
| Details |
Healthy term neonates
Delivered vaginally or by elective/emergency LSCS
Singleton births
Mother willing and able to perform KC at home
Discharged within 72 hours of vaginal delivery or within 5 days of LSCS
|
|
| ExclusionCriteria |
| Details |
Neonates requiring NICU care
Neonates with congenital anomalies
Maternal medical conditions contraindicating KC
No stable home support for follow-up |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of exclusive breastfeeding at 6 weeks (based on WHO criteria) |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean sleep duration per 24 hours at 4 & 6 weeks (parent diary)
Maternal stress (Perceived Stress Scale)
Maternal-infant bonding (Mother-Infant Bonding Scale)
KC compliance & maternal feedback (questionnaire)
|
1. 4 weeks
2. 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
04/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="14" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Kangaroo Care has already shown proven benefits for premature and low-birth-weight babies, but its role in healthy term newborns at home is less explored. As many babies are discharged early from hospitals, practicing Kangaroo Care at home may be a simple, cost-free way to promote better newborn outcomes.
This randomized controlled trial will include 100 mother–infant pairs, divided equally into two groups. Mothers in the Kangaroo Care group will receive hands-on training before discharge and will be asked to provide at least one hour of skin-to-skin care daily for four weeks, with weekly phone follow-ups for guidance. Mothers in the control group will continue routine newborn care without additional KMC instructions.
The main goal is to compare exclusive breastfeeding rates at six weeks between the two groups. Other aspects studied will include the baby’s sleep duration, the mother’s stress levels, bonding with the baby, and how easy or acceptable it is to practice Kangaroo Care at home.
All participants will be followed up weekly and again at six weeks after discharge. The data will be analyzed using standard statistical tests to see if Kangaroo Care at home offers significant advantages.
The study expects that home-based Kangaroo Care will help improve breastfeeding success, strengthen mother–baby bonding, and reduce maternal stress, with minimal risks such as mild warmth or temporary discomfort, which will be managed through proper education and support. |