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CTRI Number  CTRI/2025/02/080726 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 15/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Differences in Brain Flow during Kangaroo care 
Scientific Title of Study   Comparision of effect of cerebral blood flow in preterm neonates during kmc given by father vs mother - a cross over randomized study 
Trial Acronym  none 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Somashekhar Nimbalkar 
Designation  Professor 
Affiliation  Bhaikaka University 
Address  Department of Neonatology Pramukhswami Medical College Karamsad

Anand
GUJARAT
388325
India 
Phone  9825087842  
Fax    
Email  somu_somu@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Somashekhar Nimbalkar 
Designation  Professor 
Affiliation  Bhaikaka University 
Address  Department of Neonatology Pramukhswami Medical College Karamsad

Anand
GUJARAT
388325
India 
Phone  9825087842  
Fax    
Email  somu_somu@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Somashekhar Nimbalkar 
Designation  Professor 
Affiliation  Bhaikaka University 
Address  Department of Neonatology Pramukhswami Medical College Karamsad

Anand
GUJARAT
388325
India 
Phone  9825087842  
Fax    
Email  somu_somu@yahoo.com  
 
Source of Monetary or Material Support  
Department of Neonatology Pramukhswami Medical College Gokalnagar, Karamsad, Anand, Gujarat. Pin-388325 
 
Primary Sponsor  
Name  Bhaikaka University 
Address  Gokalnagar, Karamsad, Gujarat. Pin-388325 
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 Somashekhar Nimbalkar  Pramukhswami Medical College  Room 1, NICU, First floor, Shree Krishna Hospital, Pramukhswami Medical College
Anand
GUJARAT 
9825087842

somu_somu@yahoo.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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P073||Preterm [premature] newborn [other],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Kangaroo Care by Mother  KMC is given by mother as normally done. KMC is given for one hour. Doppler flow is assessed in middle cerebral artery 
Intervention  Kangaroo Mother care by father  KMC given to newborns as normally done. Duration of KMC is one hour. Here the provider is the father and we will assess the changes in cerebral blood flow 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  1.00 Month(s)
Gender  Both 
Details  All Newborns eligible for KMC 
 
ExclusionCriteria 
Details  None 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction rate of Resistive Index in MCA   One hour of KMC. Day 1 of intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
Pulsatility Index
Peak Systolic Velocity
End Diastolic Velocity 
One hour of KMC.
Day 1 of intervention. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   03/03/2025 
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 - NO
Brief Summary  

Skin-to-skin care, also known as Kangaroo Mother Care (KMC), is a highly regarded and extensively studied intervention for preterm neonates, involving the prone, upright positioning of the neonate in direct skin-to-skin contact on the maternal chest. KMC is associated with numerous health benefits for both the mother and the infant, including reductions in morbidity and mortality, enhanced breastfeeding success, increased weight gain, and improved mother-infant bonding [1,2]. Additionally, KMC has been shown to influence the development of neural connections, contributing to long-term cognitive benefits such as brain maturation, increased brain complexity, and better sleep organization. While the majority of research on KMC has concentrated on its effects on cardio respiratory parameters, the impact on cerebral hemodynamics remains less explored. Cerebral blood flow (CBF) is a critical component of cerebral hemodynamics and has been previously investigated in asphyxiated and preterm infants. However, no study has yet been performed on the response of cerebral blood flow (CBF) in preterm infants during KMC given by father and mother separately [3-6].

The assessment of CBF and cerebral hemodynamics can be effectively conducted using pulsed Doppler ultrasound techniques [7-9]. Spectral Doppler analysis and color flow mapping are widely utilized in the evaluation of cerebral hemodynamic changes in premature neonates, offering enhanced visualization of cerebral vessels and accurate quantification of blood flow variations over time [8].

This study aims to elucidate the differential effects of KMC provided by mothers and fathers on cerebral hemodynamic indices, specifically targeting the middle cerebral artery, alongside vital parameters in stable preterm infants.

 
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