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CTRI Number  CTRI/2016/02/006653 [Registered on: 17/02/2016] Trial Registered Retrospectively
Last Modified On: 12/12/2018
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   Community Kangaroo Mother Care for improving child survival and brain development in Low Birth Weight newborns 
Scientific Title of Study   A community-based model of delivery of Kangaroo Mother Care for improving child survival and brain development in Low Birth Weight newborns 
Trial Acronym  CKMC-DEV 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sunita Taneja 
Designation  Senior Scientist and Deputy Director 
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  45, Kalu Sarai, New Delhi

South
DELHI
110016
India 
Phone  011-46043751-55  
Fax  011-460437516  
Email  CHRD@sas.org.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nita Bhandari 
Designation  President and Director 
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  45, Kalu Sarai, New Delhi

South
DELHI
110016
India 
Phone  011-46043751-55  
Fax  011-460437516  
Email  CHRD@sas.org.in  
 
Details of Contact Person
Public Query  
Name  Dr Nita Bhandari 
Designation  President and Director 
Affiliation  Centre for Health Research and Development, Society for Applied Studies 
Address  45, Kalu Sarai, New Delhi

South
DELHI
110016
India 
Phone  011-46043751-55  
Fax  011-460437516  
Email  CHRD@sas.org.in  
 
Source of Monetary or Material Support  
Grand Challenges Canada (GCC), Sandra Rotman Centre MaRS Centre, South Tower, 101 College Street, Suite 406, Toronto, Ontario, Canada M5G 1L7  
 
Primary Sponsor  
Name  Centre for Health Research and Development Society for Applied Studies  
Address  45, Kalu Sarai, New Delhi-110016, India  
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 Sunita Taneja  Faridabad and Palwal districts of Haryana  Village Jatola,District Palwal, Tatarpur (The study is a community based study and the children will be enrolled at home . Most of the study related data collection will occur at home. Infants and their mothers will be escorted to the study office which is in the community, to assess the developmental outcomes. We have mentioned the address of the study office)
Faridabad
HARYANA 		 011-46043751
011-46043756
sunita.taneja@sas.org.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
SAS Ethics Review committee  Approved 
World Health Organization Ethics Review Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Low birth weight and/or preterm 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control   Neonatal and post neonatal care as per national guidelines 
Intervention  Intervention  Promotion of, and support to provide early skin to skin care as soon as possible after birth. Support for breastfeeding to promote optimal breastfeeding practice. Neonatal and post neonatal care as per national guidelines.  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  3.00 Day(s)
Gender  Both 
Details  Mothers and low birth weight ≥1500gms to ≤2250gms
 
 
ExclusionCriteria 
Details  - Birth weight <1500gms
- Unable to feed on offering feeds, confirmed by study team
- Infant has breathing problems or less active
- Mother does not intend to stay in study area for the next 12 months
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Developmental outcomes:
- Assessment of maternal depression
- Assessment of maternal sense of competence
- Assessment of mother infant bonding
- Assessment of mother infant interaction
- Assessment of newborn behaviour
- Assessment of infant temperament
- Assessment of cognitive function by Bayley scale
- Assessment of home environment by PROCESS
 		 - 6 weeks and 6 months
- 6 weeks and 12 months
- 6 weeks
- 6 months
- 6 weeks
- 6 months and 12 months
- 6 months and 12 months
- 12 months
 
 
Secondary Outcome  
Outcome  TimePoints 
- Neonatal mortality
- Early infant mortality
- Early initiation of breastfeeding
- Proportion exclusively breastfed
- Weight and length gain
- Incidence of infection in neonatal
- Early recognition of illness and early and appropriate care seeking practices  		 - From birth to 28 days
- From birth to 6 months
- From birth to 1 month
- 1, 3 and 6 months
- At 1,3,6 and 12 months
- 1-5 months period
- 1-5 months period 
 
Target Sample Size   Total Sample Size="550"
Sample Size from India="550" 
Final Enrollment numbers achieved (Total)= "550"
Final Enrollment numbers achieved (India)="550" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  		 26/11/2015 
Date of Study Completion (India) 31/05/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  		 Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Low birth weight (LBW) and or preterm infants will be identified through surveillance. Eligible infants will be randomized into the intervention and control groups. Mother in the intervention group will be supported by a ANM-like study workers assisted by ASHA-like study workers to provide Kangaroo mother care (KMC) to their babies at home. Breastfeeding support will also be provided to these mothers by ANM-like study workers. Essential newborn care will be delivered through Government workers in both groups. Survival will be measured in all enrolled infants through contacts at 1, 3, 6 and 12 months of age. Information will also be ascertained on initiation of breastfeeding, exclusive breastfeeding rates, incidence of infection in the neonatal and in the 1-5 months period. Development outcomes (Maternal Depression, Mother sense of competence, Mother-infant Bonding, Mother-infant interaction, Newborn Behaviour, Infant temperament, Brain development) will be measured at enrolment, 6weeks, 6 and 12 months of age. Growth will be measured at enrolment and at 1, 3, 6 and 12 months.



 
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