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CTRI Number  CTRI/2017/10/010114 [Registered on: 16/10/2017] Trial Registered Retrospectively
Last Modified On: 21/09/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   What is the effect of community initiated Kangaroo Mother Care on mortality across socioeconomic status and household expenditure on care seeking for enrolled babies 
Scientific Title of Study   Community Initiated Kangaroo Mother Care For Low Birth Weight Infants: A Poverty And Equity Impact Evaluation 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sarmila Mazumder  
Designation  Senior Scientist and Deputy Director 
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi - 110016

South
DELHI
110016
India 
Phone  011-46043751-55  
Fax  011-46043756  
Email  sarmila.mazumder@sas.org.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sarmila Mazumder  
Designation  Senior Scientist and Deputy Director 
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  Centre for Health Research and Development, Society for Applied Studies, 45, Kalu Sarai, New Delhi - 110016

South
DELHI
110016
India 
Phone  011-46043751-55  
Fax  011-46043756  
Email  sarmila.mazumder@sas.org.in  
 
Details of Contact Person
Public Query  
Name  Dr Sarmila Mazumder  
Designation  Senior Scientist and Deputy Director 
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  Centre for Health Research and Development, Society for Applied Studies 45, Kalu Sarai, New Delhi - 110016

South
DELHI
110016
India 
Phone  011-46043751-55  
Fax  011-46043756  
Email  sarmila.mazumder@sas.org.in  
 
Source of Monetary or Material Support  
Centre for Intervention Science in Maternal and Child Health (CISMAC), Centre for International Health, University of Bergen, Postbox 7804 N-5020 Bergen, Norway  
 
Primary Sponsor  
Name  Centre for Health Research and Development Society for Applied Studies 
Address  45, Kalu Sarai, New Delhi - 110016 
Type of Sponsor  Research institution 
 
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 Sarmila Mazumder  Centre for Health Research and Development, Society for Applied Studies   Village Jatola, District Palwal, Tatarpur, Faridabad
Faridabad
HARYANA 		 011-46043751-55
011-46043756
sarmila.mazumder@sas.org.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Review Committee, Centre for Health Research and Development, Society for Applied Studies, New Delhi   Approved 
Ethics Review Committee, Centre for Health Research and Development, Society for Applied Studies, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Low birth weight babies 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  KMC  KMC and routine visits by government health workers 
Comparator Agent  No intervention  Routine visits by government health workers 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  3.00 Day(s)
Gender  Both 
Details  Low Birth Weight singleton or twins or triplets babies (≥1500 to ≤2250 g) included in the trial titled “Impact of Promoting Community Initiated Kangaroo Mother Care (KMC) for Low Birth Weight Infants”, (CTRI/2016/01/006524; REF/2015/12/010221). who are either born at home or discharged from hospital, but KMC not initiated in the hospital.  
 
ExclusionCriteria 
Details  1.Infant unable to feed
2.Infant has breathing problem or is less active
3.Gross congenital malformations
4.Mother does not intend to stay in the study area for the next 6 months
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Distribution of mortality by socioeconomic status, health expenditure for care seeking and number and percentage of households experiencing catastrophic health expenditure in the intervention and control arms.   1, 3, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Health care utilization due to illness for the study baby from post enrollment to 6 months of age in the intervention and control arms  1, 3, 6 months 
Total expenditure/consumption and income of households in the intervention and control arms  1, 3, 6 months 
Household out of pocket expenses for episode(s) of non-severe and severe neonatal illness, pneumonia and diarrhea in the intervention and control arms.  1, 3, 6 months 
 
Target Sample Size
Modification(s)  		 Total Sample Size="4502"
Sample Size from India="4502" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="4502" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/08/2017 
Date of Study Completion (India) 31/10/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Yet Published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This sub-study is a part of a trial titled â€œImpact of Promoting Community Initiated Kangaroo Mother Care (KMC) for Low Birth Weight Infants”, (CTRI/2016/01/006524; REF/2015/12/010221). The main objective of this sub-study is to evaluate the impact community initiated of KMC on equity and poverty in Haryana, India. The primary outcomes of the study are ascertainment of the distribution of mortality by socioeconomic status, ascertainment of health expenditures for seeking care for the study baby and the number (%) of households that experience catastrophic health expenditures due to health care seeking for the study baby from post enrolment to 6 months of age in the intervention and control arms. 

Data on household assets are collected prospectively for all households in the main trial. An asset index will be constructed from these data and used to classify households in the intervention and control group by socio-economic status. We will summarize inequalities in mortality in both groups by the Concentration Index and by Consecration Curves.

 
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