Low Birth WeightNCT03506698
Kangaroo Mother Care Implementation Research for Accelerating Scale-up
An observational study of Low Birth Weight, run by Rajiv Bahl at 3 sites in Ethiopia.
Trial summary
The implementation research project aims to develop and evaluate models for scaling up KMC in health facilities across India and Ethiopia and thereby develop effective approaches to achieve high population coverage Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Low Birth Weight
- What is being tested?
- Kangaroo Mother Care (KMC)
- How many people
- 3,804 participants
- Where
- 3 sitesEthiopia
- Study dates
- 15 Jun 2017to 28 Feb 2020
- 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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: newborn babies with birth weight less than 2000gm born in the geographic area targeted by the intervention, including all babies born in health facilities and in the community
Who may be able to join
- All newborns who are less than 2000 gm born within the study facilities during the study period.
Who cannot join
- Newborns who are sick per predefined criteria will not be provided KMC until they have been stabilized. Criteria for delay of initiation include: critical illness including apnea, decreased respiratory rate <20 breaths per minute, grunting, cyanosis, severe chest in-drawing, convulsions, unconsciousness, and severe hypothermia <32°F.
Trial locations and contacts
3 sites in 1 country.
Ethiopia3 sites
Hawassa University Referral Hospital
Awasa
Felege Hiwot Hospital
Bahir Dar
Ayder Comprehensive Specialized Hospital
Mek'ele
About this study
The implementation research project aims to develop and evaluate models for scaling up KMC in health facilities across India and Ethiopia and thereby develop effective approaches to achieve high population coverage
Read the detailed description
Kangaroo Mother Care (KMC) is the practice of early, continuous and prolonged skin-to-skin contact between the mother and the baby with exclusive breastfeeding. Despite clear evidence of impact in improving survival and health outcomes among low birth weight infants, KMC coverage has remained low and implementation has been limited. The multi-site project includes formative research to identify barriers and contextual factors that affect implementation and utilization of KMC and design scalable models to deliver KMC across the facility-community continuum. This will be followed by implementation and evaluation of these models in routine care settings, in an iterative fashion, with the aim of reaching a successful model for wider district, state and national-level scale-up. The aim is to successfully provide KMC to 80% or more of babies born in the study area weighing under 2000 grammes
- Conditions
- Low Birth Weight
- Being tested
- Kangaroo Mother Care (KMC)
- Keywords
- Birth weight
- Medical subject headings
- Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo Mother Care (KMC)Other
Skin to skin contact of newborns with mothers or caregiver for a minimum of at least eight hours over a 24-hours period, along with exclusive breastfeeding or breast milk feeding via tube or spoon
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective coverage of KMC at 7 days after discharge
Effective coverage will be defined as adoption of skin-to-skin care for at least 8 hours and exclusive breastfeeding in the 24 hours prior to assessment
Measured: 7 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start15 Jun 2017
- Primary completion30 May 2019
- Study completion28 Feb 2020
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 WeightStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,804 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rajiv Bahl
- Sponsor type
- University, hospital or other
- Collaborators
- Mekelle University, Emory University, Emory University Ethiopia, Hawassa University
- Responsible party
- Sponsor-investigator, Rajiv Bahl, World Health Organization
- Investigators
- Araya Abrha Medhanyie, PhD, Principal investigator, Mekelle UniversityAbebe Gebremariam Gobezayehu, MD, Principal investigator, Emory University EthiopiaJohn Cranmer, DNP, MPH, Principal investigator, Emory UniversityHenok Tadele Dangiso, MD, Principal investigator, Hawassa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506698
- Sponsor's protocol ID
- ERC.0002716
- Status last verified
- Apr 2021
- First submitted
- 22 Mar 2018
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 8 Apr 2021. 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
- NCT03506698
- Acronym / sponsor ID
- ERC.0002716
- Conditions
- Low Birth Weight
- Keywords
- Birth weight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,804 participants (actual)
- Lead sponsor
- Rajiv BahlUniversity, hospital or other
- Collaborators
- Mekelle University, Emory University, Emory University Ethiopia, Hawassa University
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 24 Apr 2018 (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.
The implementation research project aims to develop and evaluate models for scaling up KMC in health facilities across India and Ethiopia and thereby develop effective approaches to achieve high population coverage
Detailed description
Kangaroo Mother Care (KMC) is the practice of early, continuous and prolonged skin-to-skin contact between the mother and the baby with exclusive breastfeeding. Despite clear evidence of impact in improving survival and health outcomes among low birth weight infants, KMC coverage has remained low and implementation has been limited. The multi-site project includes formative research to identify barriers and contextual factors that affect implementation and utilization of KMC and design scalable models to deliver KMC across the facility-community continuum. This will be followed by implementation and evaluation of these models in routine care settings, in an iterative fashion, with the aim of reaching a successful model for wider district, state and national-level scale-up. The aim is to successfully provide KMC to 80% or more of babies born in the study area weighing under 2000 grammes
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- newborn babies with birth weight less than 2000gm born in the geographic area targeted by the intervention, including all babies born in health facilities and in the community
Key inclusion criteria (1 listed)
- All newborns who are less than 2000 gm born within the study facilities during the study period.
Key exclusion criteria (1 listed)
- Newborns who are sick per predefined criteria will not be provided KMC until they have been stabilized. Criteria for delay of initiation include: critical illness including apnea, decreased respiratory rate <20 breaths per minute, grunting, cyanosis, severe chest in-drawing, convulsions, unconsciousness, and severe hypothermia <32°F.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kangaroo Mother Care (KMC)Skin to skin contact of newborns with mothers or caregiver for a minimum of at least eight hours over a 24-hours period, along with exclusive breastfeeding or breast milk feeding via tube or spoon | Other | – |
Primary outcome
Effective coverage of KMC at 7 days after discharge
Time frame: 7 days after discharge
Effective coverage will be defined as adoption of skin-to-skin care for at least 8 hours and exclusive breastfeeding in the 24 hours prior to assessment
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 8 Apr 2021.
- 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: No
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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.
Araya Abrha Medhanyie, PhD principal investigator
Mekelle University
Abebe Gebremariam Gobezayehu, MD principal investigator
Emory University Ethiopia
John Cranmer, DNP, MPH principal investigator
Emory University
3 sites 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, run by Rajiv Bahl at 3 sites in Ethiopia.
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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ethiopia. 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 7 days after discharge (time frame: 7 days after discharge). 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 NCT03506698, 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 8 Apr 2021.