Kangaroo Mother Care implementation research for accelerating scale-up in Uttar Pradesh, India

• Register: ISRCTN
• Last refreshed on: 27 February 2024
• Main ID: ISRCTN12286667
• Date of registration: 30/01/2018
• Prospective Registration: Yes
• Primary sponsor: The World Health Organization
• Public title: Kangaroo Mother Care implementation research for accelerating scale-up in Uttar Pradesh, India
• Scientific title: Impact of an implementation science driven model on improving coverage and quality of Kangaroo Care at scale
• Date of first enrolment: 01/03/2018
• Target sample size: 462
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN12286667
• Study type: Interventional
• Study design: Interventional non-randomised study (Other)
• Phase: Not Applicable

Countries of recruitment

India

Contacts

• Name: Aarti Kumar

• Name: Vishwajeet Kumar

Key inclusion & exclusion criteria

Inclusion criteria: 1. All babies of birthweight less than 2000g born in health facilities and in the community in the geographic area targeted by the intervention
2. Newborns who are severely sick according to pre-defined criteria (does not tolerate oral feeds, severe respiratory distress including respiratory rate less than 20 breaths per minute, grunting, central cyanosis, very severe chest in-drawing, convulsions, unconsciousness and severe hypothermia of less than 32 degrees Centigrade) will have the initiation of KMC delayed until they have stabilized
Exclusion criteria: Deaths, referrals, LAMA etc in the first 3 days of life, irrespective of birth weight

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Infants with birth weight <2000g
Neonatal Diseases

Intervention(s)

This is an implementation research study to understand the health system and community context, and accordingly design a district-level model for KMC implementation and evaluate whether it is successful in leading to an uptake of high quality KMC in >80% of stable babies with birth weight < 2000g from the study population.

The trialists are currently designing a district-level model for KMC implementation through the health system, which includes the systems, processes, people, infrastructure, etc. that they hypothesize will lead to the desired coverage (>80%) and quality of KC at a population level. The model is being co-designed with health system staff at various levels of administration, health providers, frontline health workers, mothers and community members based on principles of design thinking, systems dynamics and implementation science. The model will be finalized and rolled out by 28/02/2018 - after which, they will start evaluating whether it is leading to the desired primary outcomes, i.e., coverage (>80% of stable babies with birthweight <2000g) and quality of KC (>8 hours skin-to-skin contact and exclusive breastfeeding as measured at discharge and 7 days post discharge).

This implementation research partnership has been set up between Community Empowerment Lab (CEL) and the National Health Mission of Uttar Pradesh state in India, and involves establishment of an incubation lab for KC implementation based on principles of design thinking, systems dynamics and implementation science in 2 districts of Uttar Pradesh. The initial part of the study involves understanding the health system and community context for introducing KC, and co-designing a district-level KC implementation model comprising of infrastructure, systems, processes and people that will n

Primary Outcome(s)

Population-level effective coverage of KC, as defined by percentage of infants in the study population with birthweight < 2000g who receive KC for at least 8 hours along with exclusive breastfeeding during the 24-hour period prior to data collection. It will be measured based on participant response to a structured questionnaire administered by an independent data collector at discharge from the KC facility, and at 7 days after discharge. Birth weight will be based on birth weight measured and reported at delivery facilities in cases of institutional delivery, and measured at home and reported by frontline health workers (ASHA) in case of home deliveries.

Secondary Outcome(s)

1. Mean days of KC provided to infants at the population level, i.e., mean number of days that KC was received by infants with birth weight < 2000g during the neonatal period. This will be measured based on participant response to a structured questionnaire administered by an independent data collector at 28 days of age
2. Percent of infants with birth weight < 2000g receiving any KC (any duration in the last 24 hours) at 28 days of age. This will be measured based on participant response to a structured questionnaire administered by an independent data collector at 28 days of age
3. Percent of infants with birth weight < 2000g who were exclusively breastfed during the 24-hour period prior to data collection, at discharge, 7 days post discharge, and at 28 days of age
4. Neonatal mortality rate (including early neonatal mortality rate) in infants with birth weight < 2000g

Secondary ID(s)

CELIEC/2016009 v1.2, CTRI/2017/07/008988

NCT03098069; NCT03419416; NCT03506698

Nil known

Source(s) of Monetary Support

Bill and Melinda Gates Foundation

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Community Empowerment Lab Institutional Ethics Committee, 20/10/2016, ref: CELIEC/2016009

Results

• Date Completed: 31/03/2022