- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03098069
Implementation Research on Scaling up Kangaroo Mother Care (KMC) (KMC-Scaleup)
Kangaroo Mother Care Implementation Research for Accelerating Scale-up
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Haryana
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Sonipat, Haryana, India, 131001
- CHRD, Society for Applied Studies
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Effective coverage of KMC at discharge from hospital
Time Frame: At the time of discharge from hospital, will vary with each baby
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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.
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At the time of discharge from hospital, will vary with each baby
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Effective coverage of KMC at home, 7 days after hospital discharge
Time Frame: 7 days after discharge from hospital
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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.
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7 days after discharge from hospital
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Population-level duration of KMC
Time Frame: First 28 days of life
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Number of days KMC was received by infants in the population with birth weight less than 2000gm during the neonatal period.
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First 28 days of life
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Any KMC received
Time Frame: First 28 days of life
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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
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First 28 days of life
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Infants exclusively breastfed
Time Frame: First 28 days of life
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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
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First 28 days of life
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Neonatal mortality
Time Frame: 1 year
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Number of deaths in infants between birth to 28 days of life expressed per 1000 live births.
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1 year
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Cost of KMC scale up
Time Frame: 1 year
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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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1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sarmila Mazumder, MBBS, PhD, CHRD, Society for Applied Studies
Publications and helpful links
General Publications
- Mony PK, Tadele H, Gobezayehu AG, Chan GJ, Kumar A, Mazumder S, Beyene SA, Jayanna K, Kassa DH, Mohammed HA, Estifanos AS, Kumar P, Jadaun AS, Hailu Abay T, Washington M, W/Gebriel F, Alamineh L, Fikre A, Kumar A, Trikha S, Ashebir Gebregizabher F, Kar A, Bilal SM, Belew ML, Debere MK, Krishna R, Dalpath SK, Amare SY, Mohan HL, Brune T, Sibley LM, Tariku A, Sahu A, Kumar T, Hadush MY, Gowda PD, Aziz K, Duguma D, Singh PK, Darmstadt GL, Agarwal R, Gebremariam DS, Martines J, Portela A, Jaiswal HV, Bahl R, Rao Pn S, Tadesse BT, Cranmer JN, Hailemariam D, Kumar V, Bhandari N, Medhanyie AA; KMC Scale-Up Study Group. Scaling up Kangaroo Mother Care in Ethiopia and India: a multi-site implementation research study. BMJ Glob Health. 2021 Sep;6(9):e005905. doi: 10.1136/bmjgh-2021-005905.
- Medhanyie AA, Alemu H, Asefa A, Beyene SA, Gebregizabher FA, Aziz K, Bhandari N, Beyene H, Brune T, Chan G, Cranmer JN, Darmstadt G, Duguma D, Fikre A, Andualem BG, Gobezayehu AG, Mariam DH, Abay TH, Mohan HL, Jadaun A, Jayanna K, Kajal FNU, Kar A, Krishna R, Kumar A, Kumar V, Madhur TK, Belew ML, M R, Martines J, Mazumder S, Amin H, Mony PK, Muleta M, Pileggi-Castro C, Pn Rao S, Estifanos AS, Sibley LM, Singhal N, Tadele H, Tariku A, Lemango ET, Tadesse BT, Upadhyay R, Worku B, Hadush MY, Bahl R; KMC Scale-Up Study Group. Kangaroo Mother Care implementation research to develop models for accelerating scale-up in India and Ethiopia: study protocol for an adequacy evaluation. BMJ Open. 2019 Nov 21;9(11):e025879. doi: 10.1136/bmjopen-2018-025879.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERC.0002716
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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