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CTRI Number  CTRI/2025/03/083657 [Registered on: 28/03/2025] Trial Registered Prospectively
Last Modified On: 27/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Exploratory study 
Study Design  Other 
Public Title of Study   To study the effects of kangaroo mother care on heart function in preterm babies 
Scientific Title of Study   Impact of kangaroo mother care on the preterm cardiac functions: an exploratory study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rupam Das 
Designation  Senior Resident 
Affiliation  Bharati Vidyapeeth Deemed University Medical College and Research Centre 
Address  NICU, Bharati Hospital, Dhankawadi, Pune,PIN 411043

Pune
MAHARASHTRA
411043
India 
Phone  6000622460  
Fax    
Email  rd.rupam21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rema Nagpal 
Designation  Associate Professor 
Affiliation  Bharati Vidyapeeth Deemed University Medical College and Research Centre 
Address  NICU, Bharati Hospital, Dhankawadi, Pune,PIN 411043

Pune
MAHARASHTRA
411043
India 
Phone  9420724063  
Fax    
Email  remanagpal@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Rupam Das 
Designation  Senior Resident 
Affiliation  Bharati Vidyapeeth Deemed University Medical College and Research Centre 
Address  NICU, Bharati Hospital, Dhankawadi, Pune,PIN 411043

Pune
MAHARASHTRA
411043
India 
Phone  6000622460  
Fax    
Email  rd.rupam21@gmail.com  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth Deemed University Medical College, Pune, Maharashtra, India,PIN 411043 
 
Primary Sponsor  
Name  Bharati Vidyapeeth Deemed University Medical College Pune Maharashtra 
Address  NICU, Bharati Hospital, Dhankawadi, Pune, Maharashtra, India, PIN 411043 
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 Rupam Das  Bharati Hospital, Pune  Department of Neonatology, Divison of ICU, Room NICU
Pune
MAHARASHTRA 		 6000622460

rd.rupam21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth Deemed University Medical College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  8.00 Day(s)
Age To  60.00 Day(s)
Gender  Both 
Details  1.Preterm neonates between 28 and 37 weeks of corrected gestational age, who are
clinically stable, and have had atleast more than 3 days of skin-to-skin care by caregivers
2. Preterm neonates of more than 7 days of age
3. Babies on minimal non-invasive respiratory support (CPAP less than 6 and FiO2 less than 25%, or HFNC less than 5 litres/min and FiO2 less than 25%) 
 
ExclusionCriteria 
Details  Neonates with the following clinical conditions will be excluded from the study:
1. Congenital heart disease
2. Major congenital malformations
3. Birth asphyxia
4. Intraventricular hemorrhage (grade 3 or more)
5. Neonates on inotropic support or received inotropes in last 48 hours at the time of enrolment
6. Neonates on sedatives currently or in the last 72 hours of enrolment
7. Haemodynamically significant patent ductus arteriosus (HsPDA) at the time of enrolment, as defined by clinical team
8. PPHN (Persistent Pulmonary Hypertension of Newborn) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To assess the percentage change in right ventricle and left ventricle cardiac output before and after skin-to-skin care in preterm neonates.
2. To assess the percentage changes in right ventricle and left ventricle systolic function before and after skin-to-skin care in preterm neonates. 		 Before and after echocardiography
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess changes in cardio-physiological parameters before and after skin-to-skin care (HR, dips in oxygen saturations of more than 5% from baseline, axillary temperature) in preterm neonates  Before and after echocardiography 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   07/04/2025 
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="0"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rd.rupam21@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Every preterm newborn in their NICU stay undergoes KMC also called as Kangaroo Mother Care(Skin-to-skin care). KMC provides many benefits to the baby such as more stable breathing patterns, fewer bradycardic episodes, and reduced periodic breathing. Brief exposure to skin-to-skin contact has also been linked to favourable infant and maternal outcomes, including a better stress response, improved sleep organization, and enhanced cognitive control. There are also long-term benefits too. In our study we want to look into how the cardiac hemodynamics changes and improves after KMC by doing an echocardiography before and after KMC is being given. 
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