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Completed

NCT Number: NCT02613624

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)

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.

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Key information

Conditions

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRD, Society for Applied Studies

Palwal, Haryana, 121102, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  1. Perceptions and practices of maternal and newborn care

    Time frame: 1 year

    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.

  2. Social norms around birthing practices

    Time frame: 1 year

    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.

  3. Awareness and perception around KMC

    Time frame: 1 year

    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.

  4. Promotion of KMC

    Time frame: 1 year

    To identify ways to promote KMC in the community.

Sponsors and collaborators

Lead sponsor

Society for Applied Studies

Other

Collaborators

  • Centre For International Health

Registry information

Official study title

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

Acronym: CKMC

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 24, 2015
Registry last updated
Jan 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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