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)

Low-Birth-Weight Clinical Trial

— CKMC  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613624
• Other study ID #: 2014/1913/REK vest
• Status: Completed
• Phase: N/A
• First received: October 12, 2015
• Last updated: January 11, 2016
• Start date: April 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Society for Applied Studies
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 7 Days

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Birth Weight
• Low-Birth-Weight

Locations

Country	Name	City	State
India	CHRD, Society for Applied Studies	Palwal	Haryana

Sponsors (2)

Lead Sponsor	Collaborator
Society for Applied Studies	Centre For International Health

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Define intervention package	To define an intervention package, including the most effective way(s) to promote KMC in the study setting.	1 year	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Promotion of KMC	To identify ways to promote KMC in the community.	1 year	No