Formative Research to Develop an Intervention Package to Promote Practice of Kangaroo Mother Care for Low Birth Weight and Preterm Infants in a Community (CKMC) (CKMC)

Formative Research to Develop an Intervention Package for Promotion of Kangaroo Mother Care for Low Birth Weight and Preterm Infants in a Community: In Preparation for a Randomized Controlled Trial to Examine Impact of Community Kangaroo Mother Care on Neonatal and Early Infant Mortality

The study is being conducted to develop an intervention to assess the feasibility of implementing Kangaroo Mother Care (KMC) for low birth weight (LBW) and preterm babies in a community setting. A prototype intervention package will be developed using information obtained from in-depth interviews, focus group discussions and other qualitative research techniques. These interviews will help us identify current behaviours, barriers to adoption of KMC and effective ways to promote KMC in the community. The prototype intervention will be refined by conducting acceptability studies (household trials) with few mothers. The study team are identifying LBW and preterm infants, demonstrating to mothers how to practice KMC and following up till KMC is stopped. The process is being documented using observations and interviews. Information is obtained on acceptability of KMC, number of hours per day and number of days KMC was given, breastfeeding practices and support provided by other family members.

Study Overview

• Status: Completed
• Conditions: Low-Birth-Weight

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• India
  • Haryana
    • Palwal, Haryana, India, 121102
      • CHRD, Society for Applied Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Rural and semi urban population of two primary health centre areas in two districts of the state of Haryana, India.

Description

Inclusion Criteria:

• Low birth weight or preterm newborns

Exclusion Criteria:

• Babies with hospitalization criteria
• unable to feed or weight less than 1500 grams at birth

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and acceptability of community based KMC	To determine whether community KMC is feasible to implement in the study setting and if so, can high enough adoption rates be achieved. This will be ascertained by documenting proportion of mothers doing KMC, number of hours each day and number of days skin to skin contact is given.	1 year
Define intervention package	To define an intervention package, including the most effective way(s) to promote KMC in the study setting.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceptions and practices of maternal and newborn care	To ascertain perceptions, beliefs and practices around pregnancy, delivery and maternal and newborn care. Qualitative research methods such as focus group discussions, in-depth interviews and observations using open ended questionnaires, interview guides and checklists will be used.	1 year
Social norms around birthing practices	To identify social norms around birthing practices for normal, LBW infants and preterms. Qualitative research methods such as focus group discussions, in-depth interviews and observations using open ended questionnaires, interview guides and checklists will be used.	1 year
Awareness and perception around KMC	To ascertain awareness and perceptions around KMC. Qualitative research methods such as focus group discussions, in-depth interviews and observations using open ended questionnaires, interview guides and checklists will be used.	1 year
Promotion of KMC	To identify ways to promote KMC in the community.	1 year

Collaborators and Investigators

• Sponsor: Society for Applied Studies
• Collaborators: Centre For International Health
• Investigators: Principal Investigator: Sarmila Mazumder, MBBS, PhD, Centre for Health Research and Development, Society for Applied Studies, New Delhi

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: October 12, 2015
• First Submitted That Met QC Criteria: November 21, 2015
• First Posted (Estimate): November 24, 2015

Study Record Updates

• Last Update Posted (Estimate): January 12, 2016
• Last Update Submitted That Met QC Criteria: January 11, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: KMC in community
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: 2014/1913/REK vest