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Clinical Trials/NCT02613624
NCT02613624
Completed
Not Applicable

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

Society for Applied Studies1 site in 1 country28 target enrollmentApril 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low-Birth-Weight
Sponsor
Society for Applied Studies
Enrollment
28
Locations
1
Primary Endpoint
Feasibility and acceptability of community based KMC
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
January 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Feasibility and acceptability of community based KMC

Time Frame: 1 year

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.

Define intervention package

Time Frame: 1 year

To define an intervention package, including the most effective way(s) to promote KMC in the study setting.

Secondary Outcomes

  • Social norms around birthing practices(1 year)
  • Perceptions and practices of maternal and newborn care(1 year)
  • Awareness and perception around KMC(1 year)
  • Promotion of KMC(1 year)

Study Sites (1)

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