| CTRI Number |
CTRI/2025/04/083903 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Improving KMC among mothers who have given birth to preterm and/or low birth weight infants |
|
Scientific Title of Study
|
Kangaroo Care in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SOMASHEKHAR NIMBALKAR |
| Designation |
Professor and Head |
| Affiliation |
BHAIKAKA UNIVERSITY |
| Address |
Department of Neonatology,
Pramukhswami Medical College,
Karamsad, Anand, Gujarat.
Pin-388325
Anand
GUJARAT
388325
India |
| Phone |
9825087842 |
| Fax |
|
| Email |
somu_somu@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SOMASHEKHAR NIMBALKAR |
| Designation |
Professor and Head |
| Affiliation |
BHAIKAKA UNIVERSITY |
| Address |
Department of Neonatology,
Pramukhswami Medical College,
Karamsad, Anand, Gujarat.
Pin-388325
GUJARAT
388325
India |
| Phone |
9825087842 |
| Fax |
|
| Email |
somu_somu@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
SOMASHEKHAR NIMBALKAR |
| Designation |
Professor and Head |
| Affiliation |
BHAIKAKA UNIVERSITY |
| Address |
Department of Neonatology,
Pramukhswami Medical College,
Karamsad, Anand, Gujarat.
Pin-388325
GUJARAT
388325
India |
| Phone |
9825087842 |
| Fax |
|
| Email |
somu_somu@yahoo.com |
|
|
Source of Monetary or Material Support
|
| National Institutes of Health (NIH)
9000 Rockville Pike,
Bethesda, Maryland 20892
301-496-4000
TTY 301-402-9613 |
|
|
Primary Sponsor
|
| Name |
National Institutes of Health (NIH) |
| Address |
National Institutes of Health (NIH) 9000 Rockville Pike
Bethesda Maryland 20892 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Nisha Fahey |
Pramukhswami Medical College |
NICU, FIrst Floor, Posterior Building of Shree Krishna Hospital
Anand
GUJARAT |
9909940010
nisha.fahey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-2 Bhaikaka University, karamsad Anand Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mothers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Intervention |
All participants will receive information about the lifesaving benefits of Kangaroo Care. |
| Intervention |
Intensifying KMC |
Intervention to improve KMC by additional information using plays, songs, etc in the NICU and at home |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Mothers of an infant born with low birthweight who is hospitalized in the NICU at Shree Krishna Hospital with an anticipated discharge weight of less than 2500g
2. Must reside in a village within a 50 kilometer radius of Shree Krishna Hospital and plan to live there for at least 6 weeks after NICU discharge
3. Speaks Gujarati
4. At least 18 years old
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Uptake, Frequency, and Adherence of community-based Kangaroo Care |
At discharge, one months after discharge and three months after discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Maternal Intention and Self-Efficacy for Kangaroo Care |
These behavioral belief outcomes will be assessed through standardized questionnaires. At baseline, participants will complete a questionnaire about their intention to perform community-based Kangaroo Care at home. After 6 weeks, they will complete the Maternal Self-Efficacy Scale. |
| Implementation Outcomes |
Implementation outcomes (acceptability, appropriateness, material costs, engagement, feasibility, and usability) will be assessed using qualitative and quantitative measurements throughout the 6-week follow up period. |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
07/05/2025 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This research seeks to develop a
community-informed, multicomponent intervention to
promote the practice of community-based
Kangaroo Care after NICU discharge among
mothers of infants born with low birth
weight.
One in five neonatal deaths worldwide occur
in India and India has the highest incidence of
preterm birth worldwide. Kangaroo Care is a
low-cost, efficacious intervention, featuring skin-to-skin care, that improves
outcomes among low-birth-weight infants. The World Health Organization
recommends Kangaroo Care until infants reach 2500 grams or 40 weeks corrected
gestational age, which can take weeks to months. A critical gap in the current
efforts to promote Kangaroo Care surrounds the transition period from facility
to the community.
ï‚· Aim 1: Use focus groups to refine
individual candidate interventions to overcome barriers to community-based
Kangaroo Care
ï‚· Aim 2: Pilot test candidate interventions
and define optimization criterion to be used
in the optimization phase of a multiphase
optimization strategy (MOST) design-based trial
ï‚· Aim 3: Conduct a MOST design-based
optimization trial to build an integrated,
multicomponent intervention to promote
community-based Kangaroo Care
|