Implementation Research on Scaling up Kangaroo Mother Care (KMC)

Low Birth Weight Babies Clinical Trial

— KMC-Scaleup  

Official title:

Kangaroo Mother Care Implementation Research for Accelerating Scale-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03098069
• Other study ID #: ERC.0002716
• Status: Completed
• Start date: August 2016
• Est. completion date: March 2019

Study information

• Verified date: April 2018
• Source: Society for Applied Studies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This implementation research aims to accelerate effective and high coverage of Kangaroo Mother Care in district Sonipat in the state of Haryana, India. The project is being led by government of Haryana. KMC units will be set up in selected government and private delivery facilities. KMC will be initiated for all babies with birth weight less than 2000 gm in the facilities (either in born or referred from elsewhere) and continued at home post discharge. These babies may be either born in the facility or referred to the facility. A linkage with community health workers will be established to support mothers to continue KMC at home.

Description:

Babies born with low birth weight are at increased risk of mortality. The global burden of low birth weight babies is high with 15 million neonates being born preterm each year. Complications from preterm births result in over one million deaths, comprising 35% of all newborn mortality.

The way forward is to achieve an effective and equitable implementation of all those interventions for which evidence of efficacy is well established. One of the efficacious interventions is Kangaroo Mother Care (KMC). KMC has been demonstrated to promote physiologic stability, facilitate early breastfeeding, provide a thermally supportive environment, reduce the risk of serious infections, and reduce the mortality of hospitalized, stable preterm and low birth weight infants. This practice also promotes bonding between infants and their mothers during the first hours and days of life. The "Every Newborn Action Plan" endorsed and launched by the World Health Assembly in May 2014 includes the goal of scaling up KMC to 50% of babies weighing under 2000 grams by 2020, and to 75% of these babies by 2025.

This implementation research aims to promote KMC scale up in a district of Haryana. The steps include formative research to identify barriers and facilitators; designing of scalable models to deliver KMC across the facility-community continuum; implementation and evaluation of these models aiming towards wider national or state-level scale-up. Learning at each stage of this process will be applied to refining and improving the KMC delivery model. This proposal aims to develop, implement and evaluate a delivery model for KMC. The study will be implemented in two phases: i) development of a delivery model and ii) implementation and evaluation of the model.

The performance of the model will be assessed against a pre-defined success criterion of 80% or higher coverage of effective KMC at the population level.

KMC will be implemented at three levels, pre-facility, facility and post-facility.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 911
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Minutes

Eligibility

Inclusion Criteria:

• Babies with birth weight less than 2000g born in the study area.

Exclusion Criteria:

• Newborns who are severely sick will have the initiation of KMC delayed until stabilization.

Related Conditions & MeSH terms

• Birth Weight
• Kangaroo Mother Care Scale up
• Low Birth Weight Babies

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Society for Applied Studies	All India Institute of Medical Sciences, New Delhi, Government of Haryana, World Health Organization

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective coverage of KMC at discharge from hospital	Proportion of babies who weighed less than 2000g at birth and got KMC for atleast 8 hours and were exclusively breastfed in the last 24 hours, assessed at discharge.	At the time of discharge from hospital, will vary with each baby
Primary	Effective coverage of KMC at home, 7 days after hospital discharge	Proportion of babies who weighed less than 2000g at birth and got KMC for atleast 8 hours and were exclusively breastfed in the last 24 hours, assessed at 7 days after hospital discharge.	7 days after discharge from hospital
Secondary	Population-level duration of KMC	Number of days KMC was received by infants in the population with birth weight less than 2000gm during the neonatal period.	First 28 days of life
Secondary	Any KMC received	Percent of infants with birth weight less than 2000gm receiving any KMC i.e. any duration in last 24 hours, at 28 days of life	First 28 days of life
Secondary	Infants exclusively breastfed	Percent of infants with birth weight less than 2000gm exclusively breastfed in the last 24 hours, ascertained at discharge, 7 days post discharge and 28 days of life	First 28 days of life
Secondary	Neonatal mortality	Number of deaths in infants between birth to 28 days of life expressed per 1000 live births.	1 year
Secondary	Cost of KMC scale up	Cost estimation of establishing KMC units in selected delivery facilities, recurring cost of implementing KMC in these units and cost of implementing KMC at home post discharge.	1 year