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Implementation Research on Scaling up Kangaroo Mother Care (KMC) (KMC-Scaleup)

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ClinicalTrials.gov Identifier: NCT03098069
Recruitment Status : Completed
First Posted : March 31, 2017
Last Update Posted : September 19, 2019
Sponsor:
Collaborators:
Government of Haryana
All India Institute of Medical Sciences, New Delhi
World Health Organization
Information provided by (Responsible Party):
Society for Applied Studies

Brief 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.

Condition or disease
Low Birth Weight Babies Kangaroo Mother Care Scale up

Detailed 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.

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Study Type : Observational
Actual Enrollment : 911 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Kangaroo Mother Care Implementation Research for Accelerating Scale-up
Study Start Date : August 2016
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Group/Cohort
KMC Scale up in a district
This is an implementation research project on scaling up KMC in selected government and private health facilities in an entire district, aiming to cover newborns weighing less than 2000gms at birth.



Primary Outcome Measures :
  1. Effective coverage of KMC at discharge from hospital [ Time Frame: At the time of discharge from hospital, will vary with each baby ]
    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.

  2. Effective coverage of KMC at home, 7 days after hospital discharge [ Time Frame: 7 days after 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 7 days after hospital discharge.


Secondary Outcome Measures :
  1. Population-level duration of KMC [ Time Frame: First 28 days of life ]
    Number of days KMC was received by infants in the population with birth weight less than 2000gm during the neonatal period.

  2. Any KMC received [ Time Frame: First 28 days of life ]
    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

  3. Infants exclusively breastfed [ Time Frame: First 28 days of life ]
    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

  4. Neonatal mortality [ Time Frame: 1 year ]
    Number of deaths in infants between birth to 28 days of life expressed per 1000 live births.

  5. Cost of KMC scale up [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   up to 28 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study participants will include babies of birth weight less than 2000g born in the study area. Newborns who are severely sick according to pre-defined criteria will have the initiation of KMC delayed until they have stabilized.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098069


Locations
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India
CHRD, Society for Applied Studies
Sonipat, Haryana, India, 131001
Sponsors and Collaborators
Society for Applied Studies
Government of Haryana
All India Institute of Medical Sciences, New Delhi
World Health Organization
Investigators
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Principal Investigator: Sarmila Mazumder, MBBS, PhD CHRD, Society for Applied Studies
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Society for Applied Studies
ClinicalTrials.gov Identifier: NCT03098069    
Other Study ID Numbers: ERC.0002716
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Society for Applied Studies:
Kangaroo Mother Care
Low Birth Weight
Implementation research
Additional relevant MeSH terms:
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Birth Weight
Body Weight