Low Birth Weight BabiesKMC-ScaleupNCT03098069
Implementation Research on Scaling up Kangaroo Mother Care (KMC)
An observational study of Low Birth Weight Babies and Kangaroo Mother Care Scale up, run by Society for Applied Studies at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 1 minute to 28 minutesHealthy volunteers can take part
- Conditions the study is for
- Low Birth Weight Babies, Kangaroo Mother Care Scale up
- How many people
- 911 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2016to Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 28 minutes
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Babies with birth weight less than 2000g born in the study area.
Who cannot join
- Newborns who are severely sick will have the initiation of KMC delayed until stabilization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kangaroo Mother Care Implementation Research for Accelerating Scale-up
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.
Read the 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.
- Keywords
- Kangaroo Mother Care, Low Birth Weight, Implementation research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of discharge from hospital, will vary with each baby
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.
Measured: 7 days after discharge from hospital
Secondary outcomes (5)
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.
Measured: First 28 days of life
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
Measured: First 28 days of life
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
Measured: First 28 days of life
Neonatal mortality
Number of deaths in infants between birth to 28 days of life expressed per 1000 live births.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study startAug 2016
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Birth Weight BabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 911 participants (actual)
Sponsor and investigators
- Lead sponsor
- Society for Applied Studies
- Sponsor type
- University, hospital or other
- Collaborators
- Government of Haryana, All India Institute of Medical Sciences, World Health Organization
- Responsible party
- Sponsor
- Investigators
- Sarmila Mazumder, MBBS, PhD, Principal investigator, CHRD, Society for Applied Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098069
- Sponsor's protocol ID
- ERC.0002716
- Acronym
- KMC-Scaleup
- Status last verified
- Apr 2018
- First submitted
- 16 Mar 2017
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 34518203Medhanyie 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.
PubMed 31753865
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kangaroo Mother Care Implementation Research for Accelerating Scale-up
- ClinicalTrials.gov ID
- NCT03098069
- Acronym / sponsor ID
- KMC-Scaleup / ERC.0002716
- Keywords
- Kangaroo Mother Care, Low Birth Weight, Implementation research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 911 participants (actual)
- Lead sponsor
- Society for Applied StudiesUniversity, hospital or other
- Collaborators
- Government of Haryana, All India Institute of Medical Sciences, World Health Organization
- Study start
- Aug 2016
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 31 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 minute to 28 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Babies with birth weight less than 2000g born in the study area.
Key exclusion criteria (1 listed)
- Newborns who are severely sick will have the initiation of KMC delayed until stabilization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
5 secondary outcomes
Population-level duration of KMC
Time frame: First 28 days of life
Any KMC received
Time frame: First 28 days of life
Infants exclusively breastfed
Time frame: First 28 days of life
Neonatal mortality
Time frame: 1 year
Cost of KMC scale up
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Derived from this study: PubMed 34518203Mony 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.
- Derived from this study: PubMed 31753865Medhanyie 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarmila Mazumder, MBBS, PhD principal investigator
CHRD, Society for Applied Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Birth Weight Babies and Kangaroo Mother Care Scale up, run by Society for Applied Studies at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective coverage of KMC at discharge from hospital (time frame: At the time of discharge from hospital, will vary with each baby). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03098069, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.