FULL DETAILS (Read-only)

CTRI Number  CTRI/2014/05/004625 [Registered on: 26/05/2014] Trial Registered Retrospectively
Last Modified On: 23/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   When to start kangaroo mother care (KMC - Skin to skin contact) in very low birth weight (VLBW) infants - Early or late? 
Scientific Title of Study   Randomized control trial comparing Early Vs Late Kangaroo Mother Care (KMC) in the kangaroo ward for stable very low birth weight infants for improving the growth outcomes at term corrected age. 
Secondary IDs if Any  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Srinivas Murki 
Address  Fernandez Hospital, Hyderguda, Hyderabad

Hyderabad
ANDHRA PRADESH
500029
India 
Phone  9392470351  
Fax    
Email  srinivasmurki2001@gmail.com  
 
Details Contact Person
Scientific Query
 
Name  Dr Deepak Sharma 
Address  Fernandez Hospital, Hyderguda, Hyderabad

Hyderabad
ANDHRA PRADESH
500029
India 
Phone  9849590876  
Fax    
Email  dr.deepak.rohtak@gmail.com  
 
Details Contact Person
Public Query
 
Name  Dr Deepak Sharma 
Address  Fernandez Hospital, Hyderguda, Hyderabad

East Godavari
ANDHRA PRADESH
500029
India 
Phone  9849590876  
Fax    
Email  dr.deepak.rohtak@gmail.com  
 
Source of Monetary or Material Support  
Fernandez Hospital, Hyderabad 
 
Primary Sponsor  
Name  Fernandez Hospital 
Address  Fernandez Hospital, Hyderguda, Opp Old MLA quarters, Hyderabad 
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  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Srinivas Murki  Neonatal Intensive Care Unit - KMC ward  Second floor, Fernandez Hospital,Hyderguda, Hyderabad
Hyderabad
 
9392470351

srinivasmurki2001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committe, Fernandez Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Neonates with birth weight less than 1100 gm 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Early Kangaroo Mother Care (KMC)  early Kangaroo mother care once the infant reaches a weight of 1150grams and baby will be followed till post menstrual age of 40 weeks of gestation.During this period, mothers will be encouraged to do KMC for at least 6 hours. 
Comparator Agent  Late Kangaroo mother care  Late Kangaroo mother care once the infant reaches a weight of 1250grams.baby will be followed till post menstrual age of 40 weeks of gestation.During this period, mothers will be encouraged to do KMC for at least 6 hours 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  3.00 Month(s)
Gender  Both 
Details  Infant fulfilling the following criteria
•Birth weight less than 1100 grams
•Singleton
•Tolerating spoon or tube feeds of 150 mL/kg/day and not on intravenous fluids
•Breathing room air
•Hemodynamically stable
 
 
ExclusionCriteria 
Details  Infants born with major malformations 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Weight, Length and Head Circumference  At 40 weeks of gestation 
 
Secondary Outcome  
Outcome  TimePoints 
Breastfeeding rates   at discharge and at 40 weeks 
Cost differences between the two groups  At discharge 
In hospital weight gain (gm/kg/day), length (cm/week) and OFC (cm/week)   till discharge 
Readmission to NICU (level III or intermediate care)  Till 40 weeks of gestation 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  
13/11/2013 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Eur J Pediatr Aug 2016 
Brief Summary
Modification(s)  

Kangaroo mother care (KMC) reduces neonatal mortality, neonatal sepsis and improves growth outcome in preterm infants. In this study, we compared the efficacy of Bbaby care in kangaroo ward (KWC)with Bbaby care in intermediate intensive care (IIC)in stable preterm infants (birth weight <1100 g) for improving the growth velocity till term corrected age. One hundred and forty-one infants were randomized to KWC (= 71) or IIC (= 70) once the infant reached a weight of 1150 g. Infants in the KWC group were shifted to the KWC immediately after randomization and those in the IIC group were given care in the IIC till they attained a weight of 1250 g and then shifted to the KWC. The average weight gains as well as weight, length, and head circumference at term corrected age were comparable in both the groups. There was significant reduction in IIC stay post randomization and increase in weight gain before discharge in the KWC group. There was a significant increase in incidence of apnea in the IIC group.

 

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