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CTRI Number  CTRI/2023/07/055500 [Registered on: 21/07/2023] Trial Registered Prospectively
Last Modified On: 19/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Impact of skin to skin contact alert device on parent complaince to KMC in low birth weight babies between 1.5-2.5kgs compared to kangaro mother care  
Scientific Title of Study   IMPACT OF SKIN-TO-SKIN CONTACT ALERT DEVICE "KANGA SURAKSHA" ON PARENT COMPLIANCE TO KANGARO MOTHER CARE IN LOW-BIRTH-WEIGHT BABIES BETWEEN 1.5-2.5KGS COMPARED TO CONVENTIONAL KANGARO MOTHER CARE A ONE YEAR HOSPITAL BASED RANDOMIZED CONTROL TRAIL 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Palle Nikitha 
Designation  MD Paediatrics 
Affiliation  Jawaharlal nehru medical college 
Address  Department of paediatrics ,jawaharlal nehru medical college, nehru nagar, KLE hospital road belgaum

Belgaum
KARNATAKA
590010
India 
Phone  7416531363  
Fax    
Email  nikithapalle1898@gmail.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Niranjana S Mahantashetti 
Designation  Prof of paediatrics and principal Jawaharlal nehru medical college 
Affiliation  Jawaharlal nehru medical college,belguam 
Address  Department of paediatrics ,jawaharlal nehru medical college, nehru nagar, KLE hospital road belgaum

Belgaum
KARNATAKA
590010
India 
Phone  9448157237  
Fax    
Email  niranjanasn@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Niranjana S mahantashetti 
Designation  Prof of paediatrics and principal Jawaharlal nehru medical college 
Affiliation  Jawaharlal nehru medical college,belguam 
Address  Department of paediatrics ,jawaharlal nehru medical college, nehru nagar, KLE hospital road belgaum


KARNATAKA
590010
India 
Phone  9448157237  
Fax    
Email  niranjanasn@yahoo.com  
 
Source of Monetary or Material Support  
Jawaharlal nehru medical college, nehru nagar, KLE hospital road belgaum Department of paediatrics ,jawaharlal nehru medical college, nehru nagar, KLE hospital road belgaum Belgaum KARNATAKA 590010 India 
 
Primary Sponsor  
Name  Jawaharlal nehru medical college ,belgaum 
Address  Department of paediatrics ,jawaharlal nehru medical college, nehru nagar, KLE hospital road belgaum 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Palle Nikitha  KLE prabhakar kore  Department of paediatrics ,jawaharlal nehru medical college, nehru nagar, KLE hospital road belgaum
Belgaum
KARNATAKA 		 7416531363

nikithapalle1898@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jawaharlal Nehru Medical College Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P969||Condition originating in the perinatal period, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kanga Suraksha Device  GROUP 1: "KANGA SURAKSHA device will be given to parents/caregivers for measuring and doing KMC.. The device will beep when the temperature of the baby falls below 36.5 degree celsius. Mothers will be taught to recognize alarms and take measures to treat hypothermia when the device alarm beeps. By translating the load that falls on the device weight gain of the baby can be monitored. "KANGA SURAKSHA" device is used along with the sling to ensure KMC is done correctly as this device works when the baby is placed in the sling with skin-to-skin contact. The device will be used till the baby attains 2.5KG weight or 40 weeks of gestation. This device can track and store data for the total duration of 30 days. This data will then be stored into a data base via a phone app. CONTROL GROUP: Babies enrolled in the control group will use the conventional cloth sling wrap for KMC. In routine care mothers will be counselled regarding how to practice KMC, importance of skin-to-skin position, detection and prevention of hypothermia in the baby. For both groups, routine neonatal care and monitoring will be provided. Mothers will be taught how to care for the low-birth-weight babies including importance of breast feeding, early initiation of breast feeding, expressing breast milk and stress on hygiene. Infants will be monitored for temperature, blood glucose, heart rate, respiratory rate and weight gain along with the number of hours of KMC recorded by health care providers. 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  40.00 Day(s)
Gender  Both 
Details  Impact of skin to skin contact alert device KANGA SURAKSHA on parent complaince to KMC in low birth weight babies between 1.5-2.5kgs compared to conventional kangaro mother care a one year hospital based RCT 
 
ExclusionCriteria 
Details  1 Infants not clinically stable or who had major congenital malformation will be excluded
2 Mother with debilitating ilness who would not be able to provide KMC
3 Those who are not willing to give consent are also excluded from study 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This KANGA SURAKSHA device will increase complainace to KMC for more than 10hours The study will be conducted over a span of one year  The study will be conducted over a span of one year 
 
Secondary Outcome  
Outcome  TimePoints 
1 will promote better weight gain in LBW babies compared to conventional kangaroo mother care

2 will improve breast feeding in babies compared to conventional kangaroo mother care 		 The study will be conducted over a span of one 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)   01/08/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Kangaroo mother care (KMC), sometimes called skin-to-skin care, is a technique of
newborn care where babies are kept skin-to-skin with a parent, typically their mother. It
is most used for Low Birth-Weight preterm babies. It ensures warmth to preterm/LBW
improves breast feeding, prevents infection and it also reduces hospital stay.
Participation of your child will help us to assess the compliance to kangaroo mother care
which promotes better weight gain, early breast feeding and early discharge.
We will divide into two groups in which one will receive "KANGA SURAKSHA" device and
other group will receive routine kangaroo mother care.
In the study you may be included in any one of the groups. If you are selected in the
intervention group you will receive the "KANGA SURAKSHA" device.
As a mother you may not practice KMC properly, you may not know when the baby
becomes cold, hence in this study the device detects hypothermia, which will alert you
to put your baby in skin-to-skin contact. This device monitors whether the baby is in
skin-to-skin contact or not, weight of the baby and checks temperature with an alarm.
This information will be obtained on phone, which will help us to monitor your
compliance to KMC and alert you when required. By practicing KMC for a longer time,
we expect that you will be able to practice breastfeeding better and in turn your baby
gains better weight. Practicing KMC will also help in early discharge.
However, we will be calling you for regular follow ups every week to monitor the weight
gain, breastfeeding, and other problems which we do routinely for all the babies in KMC.
This monitoring will be done till the baby attains 2.5kgs or 40 weeks. You will be given a dairy to note down the no. breast feeds, mode of feeding, temperature and duration of
KMC being practiced.
If you are selected in the control group you will be providing conventional KMC care to
your baby. You will be manually monitoring temperature and weight gain of your baby
as per the instructions of health care providers.
Routine monitoring of the babies in both the groups will be done by the health care
providers (Doctors and nurses) as a part of NICU care for preterm and Low birth weight
babies with KMC.
As in the intervention group weekly follow up of the babies in the control group will be
done in the KMC clinic. A self-reporting dairy similar to the interventional group would
be provided to the mothers, data of which would be collected on scheduled follow ups.
 
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