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)

NCT02613624 | Completed

• 1 other identifier: 2014/1913/REK vest
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low-Birth-Weight

Keywords

KMC in community

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Perceptions and practices of maternal and newborn care

  1 year

• Social norms around birthing practices

  1 year

• Awareness and perception around KMC

  1 year

• Promotion of KMC

  1 year

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Low birth weight or preterm newborns

You may not qualify if:

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

Sponsors & Collaborators

• Society for Applied Studies: lead
• Centre For International Health: collaborator

Study Sites (1)

CHRD, Society for Applied Studies

Palwal, Haryana, 121102, India

Location

Study Officials

• Sarmila Mazumder, MBBS, PhD

  Centre for Health Research and Development, Society for Applied Studies, New Delhi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: November 24, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

IN (1)