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CTRI Number  CTRI/2024/06/069676 [Registered on: 28/06/2024] Trial Registered Prospectively
Last Modified On: 28/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [prospective observational study with analytical design]  
Study Design  Other 
Public Title of Study   Benefits of Kangaroo mother care in infants requiring respiratory support 
Scientific Title of Study   Effect of kangaroo mother care on cerebral hemodynamics of very preterm neonates on non-invasive respiratory support- A prospective observational 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  Dr Komaragiri Sai Sreevani 
Designation  DrNB neonatology resident 
Affiliation  Fernandez Hospital, Hyderabad 
Address  Fernandez Hospital, No.8-2-698, Rd Number 12, Bhola Nagar, Banjara Hills, Hyderabad, Telangana.

Hyderabad
TELANGANA
500034
India 
Phone  9010439439  
Fax    
Email  sreevanikomaragiri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tejo Pratap Oleti 
Designation  HOD, Neonatology 
Affiliation  Fernandez Hospital 
Address  Fernandez Hospital, No.8-2-698, Rd Number 12, Bhola Nagar, Banjara Hills, Hyderabad, Telangana.

Hyderabad
TELANGANA
500034
India 
Phone  9989372490  
Fax    
Email  tejopratap@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tejo Pratap Oleti 
Designation  HOD, Neonatology 
Affiliation  Fernandez Hospital 
Address  Fernandez Hospital, No.8-2-698, Rd Number 12, Bhola Nagar, Banjara Hills, Hyderabad, Telangana.

Hyderabad
TELANGANA
500034
India 
Phone  9989372490  
Fax    
Email  tejopratap@gmail.com  
 
Source of Monetary or Material Support  
Fernandez hospital, No.8-2-698, Rd Number 12, Bhola Nagar, Banjara Hills, Hyderabad, Telangana - 500034. 
 
Primary Sponsor  
Name  Fernandez Hospital  
Address  Fernandez Hospital, No.8-2-698, Rd Number 12, Bhola Nagar, Banjara Hills, Hyderabad, Telangana - 500034 
Type of Sponsor  Research institution and hospital 
 
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 Komaragiri Sai Sreevani  Fernandez hospital  Neonatal Intensive Care Unit, Department of Neonatology, Room no 302, 3rd floor,Fernandez hospital, No.8-2-698, Rd number 12, bhola nagar, banjara hills, Hyderabad, 500034
Hyderabad
TELANGANA 
9010439439

sreevanikomaragiri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board , Fernandez Hospital  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 
Intervention  Post-KMC group  The eligible neonates will be assessed for cerebral blood flow dynamics with a neurosonogram after initiating the skin to skin contact of mother-infant dyad as a part of KMC. The assessment will be done within 2 hrs after ensuring that the KMC duration is more than equal to 1 hour. 
Comparator Agent  Pre-KMC group  The eligible neonates will be assessed for cerebral blood flow dynamics with a neurosonogram before initiating the skin to skin contact of mother-infant dyad as a part of KMC. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  99.00 Day(s)
Gender  Both 
Details  All Very preterm neonates born before 30 weeks of gestation, requiring non-invasive respiratory support and hemodynamically stable 
 
ExclusionCriteria 
Details  Neonates born with major congenital anomaly, pre-existing neurological morbidities and hydrops  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To estimate the changes in cerebral hemodynamics in very preterm neonates on non-invasive respiratory support during KMC using transcranial doppler ultrasonography in the first 3 days of its initiation.  From the starting of the initiation of KMC to the 2 consecutive days 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the changes in vital physiological parameters like heart rate, saturations and mean blood pressure before and after KMC during the first 3 days of initiation.
2) To analyze the regional cerebral oxygenation changes as measured by Near Infrared Spectroscopy (NIRS) during the first 3 days of its initiation.  
From the starting of the initiation of KMC to the 2 consecutive days 
 
Target Sample Size   Total Sample Size="53"
Sample Size from India="53" 
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)   11/07/2024 
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="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  

In neonates who were born before term gestation especially before 34 weeks it is believed to cause an interruption in their smooth and integrated neurobehavioral development.

Preterm neonates are more susceptible to neuronal injury because of their physiological immaturities in cerebral vasculature and ineffective cerebral autoregulation which can cause marked fluctuations in cerebral blood flow. This results in adverse cerebrovascular events which can have longterm effects on neurodevelopment in the form of cognitive, motor and behavioral abnormalities.

The advances in perinatal and neonatal medicine over the past two decades improved the survival of extreme and very preterm neonates which also resulted in increased neuro-morbidity among the survivors. Hence neuroprotective strategies should be made an integral part of neonatal care thereby promoting better longterm neurodevelopmental outcomes.

Kangaroo Mother Care (KMC) is a proven and effective method of care for preterm infants which means skin-to-skin contact (SSC) between the neonate and the parent especially the mother. Preterm birth results in an increase in number of days of NICU stay and separation of newborn and the mother. This SSC between mother and the baby promotes a multi-sensory stimulation for their development.

As only few studies have shown the beneficial effects of KMC on cerebral hemodynamics in very preterm neonates who are given SSC as early as possible even on non-invasive respiratory support we wish to analyze the changes to make KMC an integral part of neuroprotective care among the neonates.

Most of the studies done on stable preterm neonates were around the gestational age of 30-34 weeks of gestation and less data on neonates between 26-30 weeks of gestation who require more days of respiratory support which might effect their neurodevelopmental outcomes and these are the newborns who are separated from their parents for a longer time and hence this study might help in giving earlier and aggressive KMC as part of developmentally supportive care in these newborns. The studies were done in a single session and the consistency of the results has not been studied well. In this study we wanted to study for at least a period of 3 days to know the efficacy in a broader way.

       

 
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