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Health services research
Protocol
Kangaroo Mother Care implementation research to develop models for accelerating scale-up in India and Ethiopia: study protocol for an adequacy evaluation
  1. Araya Abrha Medhanyie1,
  2. Hibret Alemu2,
  3. Anteneh Asefa3,
  4. Selemawit Asfaw Beyene1,
  5. Fisseha Ashebir Gebregizabher4,
  6. Khalid Aziz5,
  7. Nita Bhandari6,
  8. Habtamu Beyene7,
  9. Thomas Brune8,
  10. Grace Chan9,10,
  11. John N Cranmer11,
  12. G Darmstadt12,
  13. Dereje Duguma13,
  14. Addisalem Fikre14,
  15. Bizuayehu Gashaw Andualem15,
  16. Abebe Gebremariam Gobezayehu16,
  17. Damen Haile Mariam14,
  18. Tedros Hailu Abay17,
  19. H L Mohan18,
  20. Arun Jadaun6,
  21. K Jayanna19,20,
  22. F N U Kajal21,
  23. Arin Kar22,
  24. Raghav Krishna23,
  25. Aarti Kumar23,
  26. Vishwajeet Kumar23,
  27. Tarun Kumar Madhur6,
  28. Mulusew Lijalem Belew24,
  29. Rajini M25,
  30. Jose Martines26,
  31. Sarmila Mazumder6,
  32. Hajira Amin16,
  33. Prem K Mony27,
  34. Mekonnen Muleta28,
  35. Cynthia Pileggi-Castro29,
  36. Suman Pn Rao30,
  37. Abiy Seifu Estifanos14,
  38. Lynn M Sibley31,
  39. Nalini Singhal32,
  40. Henok Tadele33,
  41. Abraham Tariku34,
  42. Ephrem Tekle Lemango35,
  43. Birkneh Tilahun Tadesse33,
  44. Ravi Upadhyay6,
  45. Bogale Worku14,36,
  46. Marta Yemane Hadush17,
  47. Rajiv Bahl29
  48. KMC Scale-Up Study Group
    1. 1School of Public Health, Mekelle University College of Health Sciences, Mekelle, Ethiopia
    2. 2Urban Health, John Snow Inc, Addis Ababa, Ethiopia
    3. 3School of Public Health, Hawassa University College of Medicine and Health Sciences, Hawassa, Ethiopia
    4. 4Tigray Regional Health Bureau, Mekelle, Ethiopia
    5. 5Department of Neonatology, University of Alberta, Edmonton, Alberta, Canada
    6. 6Centre for Health Research and Development, Society for Applied Studies, New Delhi, India
    7. 7Southern Nations, Nationalities and Peoples' Regional Health Bureau, Hawassa, Ethiopia
    8. 8Department of Neonatology, Karloniska Institute, Calgary, Alberta, Canada
    9. 9Boston Children’s Hospital, Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, USA
    10. 10Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA
    11. 11Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia, USA
    12. 12Department of Pediatrics, Stanford University School of Medicine, Stanford, California, USA
    13. 13Oromia Regional Health Bureau, Addis Ababa, Ethiopia
    14. 14Addis Ababa University, School of Public Health, Addis Ababa, Ethiopia
    15. 15Amhara National Regional Health Bureau, Bahir Dar, Ethiopia
    16. 16Emory Ethiopia, Addis Ababa, Ethiopia
    17. 17Department of Pediatrics and Child Health, Mekelle University College of Health Sciences, Mekelle, Ethiopia
    18. 18Community Mobilization, Karnataka Health Promotion Trust, Bangalore, India
    19. 19Quality Improvement, Karnataka Health Promotion Trust, Bangalore, India
    20. 20Centre for Global Public Health, University of Manitoba, Winnipeg, Manitoba, Canada
    21. 21National Health Mission, Indian Administrative Service, Lucknow, India
    22. 22Karnataka Health Promotion Trust, Bangalore, India
    23. 23Global Health, Community Empowerment Lab, Lucknow, India
    24. 24Amhara Regional Office, Emory Ethiopia, Bahirdar, Ethiopia
    25. 25Department of Health and Family Welfare, Government of Karnataka, Bangalore, India
    26. 26Centre for Intervention Science in Maternal and Child Health, Universitetet i Bergen Senter for internasjonal helse, Bergen, Norway
    27. 27Division of Epidemiology and Population Health, St. John's Research Institute, St. John's National Academy of Health Sciences, Bangalore, India
    28. 28Private Consultant, Addis Ababa, Ethiopia
    29. 29Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneva, Switzerland
    30. 30Department of Neonatology, St John’s Medical College Hospital, Bangalore, India
    31. 31Global Health, Emory University School of Public Health, Atlanta, Georgia, USA
    32. 32Department of Neonatology, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada
    33. 33Department of Pediatrics and Child Health, College of Medicine and Health Sciences, Hawassa University, Hawassa, Ethiopia
    34. 34Federal Ministry of Health, Addis Ababa, Ethiopia
    35. 35Maternal and Child Health Directorate, Federal Ministry of Health, Addis Ababa, Ethiopia
    36. 36Pediatrics Society, Addis Ababa, Ethiopia
    1. Correspondence to Dr Rajiv Bahl; bahlr{at}who.int

    Abstract

    Introduction 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. Consequently, only a small fraction of newborns that could benefit from KMC receive it.

    Methods and analysis This implementation research project aims to develop and evaluate district-level models for scaling up KMC in India and Ethiopia that can achieve high population coverage. The project includes formative research to identify barriers and contextual factors that affect implementation and utilisation 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. Implementation actions would happen at three levels: ‘pre-KMC facility’—to maximise the number of newborns getting to a facility that provides KMC; ‘KMC facility’—for initiation and maintenance of KMC; and ‘post-KMC facility’—for continuation of KMC at home. Stable infants with birth weight<2000 g and born in the catchment population of the study KMC facilities would form the eligible population. The primary outcome will be coverage of KMC in the preceding 24 hours and will be measured at discharge from the KMC facility and 7 days after hospital discharge.

    Ethics and dissemination Ethics approval was obtained in all the project sites, and centrally by the Research Ethics Review Committee at the WHO. Results of the project will be submitted to a peer-reviewed journal for publication, in addition to national and global level dissemination.

    Study status WHO approved protocol: V.4—12 May 2016—Protocol ID: ERC 2716. Study implementation beginning: April 2017. Study end: expected March 2019.

    Trial registration number Community Empowerment Laboratory, Uttar Pradesh, India (ISRCTN12286667); St John's National Academy of Health Sciences, Bangalore, India and Karnataka Health Promotion Trust, Bangalore, India (CTRI/2017/07/008988); Society for Applied Studies, Delhi (NCT03098069); Oromia, Ethiopia (NCT03419416); Amhara, SNNPR and Tigray, Ethiopia (NCT03506698).

    • kangaroo-mother care method
    • low birth weight
    • newborn
    • research protocol

    This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

    https://doi.org/10.1136/bmjopen-2018-025879

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      Footnotes

      • Collaborators Araya Abrha Medhanyie,1 Hibret Alemu,2 Anteneh Asefa,3 Selemawit Asfaw Beyene,1 Fisseha Ashebir Gebregizabher,4 Khalid Aziz,5 Nita Bhandari,6 Habtamu Beyene,7 Thomas Brune,8 Grace J Chan,9,10 John N Cranmer,11 Gary Lee Darmstadt,12 Dereje Duguma,13 Addisalem Fikre,14 Bizuayehu Gashaw Andualem,15 Abebe Gebremariam Gobezayehu,16 Damen Haile Mariam,14 Tedros Hailu Abay,17 HL Mohan,18 Arun Jadaun,6 Krishnamurthy Jayanna,20,21 F N U Kajal,22 Arin Kar,23 Raghav Krishna,24 Aarti Kumar,24 Vishwajeet Kumar,24 Tarun Kumar Madhur,6 Mulusew Lijalem Belew,25 Rajini M,26 Jose Carlos Martines,27 Sarmila Mazumder,6 Hajira Amin,16 Prem K Mony,28 Mekonnen Muleta,29 Cynthia Pileggi-Castro,30 Suman Rao,31 Abiy Seifu Estifanos,14 Lynn M Sibley,32 Nalini Singhal,33 Henok Tadele,34 Abraham Tariku,35 Ephrem Tekle Lemango,36 Birkneh Tilahun Tadesse,34 Ravi Prakash Upadhyay,6 Bogale Worku,14,37 Marta Yemane Hadush,17 Rajiv Bahl.301School of Public Health, Mekelle University College of Health Sciences, Mekelle, Ethiopia, 2Urban Health, John Snow Inc, Addis Ababa, Ethiopia, 3School of Public Health, Hawassa University College of Medicine and Health Sciences, Hawassa, Ethiopia, 4Tigray Regional Health Bureau, Mekelle, Ethiopia, 5Department of Neonatology, University of Alberta, Edmonton, Alberta, Canada, 6Centre for Health Research and Development, Society for Applied Studies, New Delhi, India, 7Southern Nations, Nationalities and Peoples' Regional Health Bureau, Hawassa, Ethiopia, 8Department of Neonatology, Karloniska Institute, Calgary, Alberta, Canada, 9Boston Children’s Hospital, Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, USA, 10Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA, 11Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia, USA, 12Department of Pediatrics, Stanford University School of Medicine, Stanford, California, USA, 13Oromia Regional Health Bureau, Addis Ababa, Ethiopia, 14Addis Ababa University, School of Public Health, Addis Ababa, Ethiopia, 15Amhara National Regional Health Bureau, Bahir Dar, Ethiopia, 16Emory Ethiopia, Addis Ababa, Ethiopia, 17Department of Pediatrics and Child Health, Mekelle University College of Health Sciences, Mekelle, Ethiopia, 18Community Mobilization, Karnataka Health Promotion Trust, Bangalore, India, 19Centre for Health Research and Development, Society for Applied Studies, New Delhi, India, 20Quality Improvement, Karnataka Health Promotion Trust, Bangalore, India, 21Centre for Global Public Health, University of Manitoba, Winnipeg, Manitoba, Canada, 22National Health Mission, Indian Administrative Service, Lucknow, India, 23Karnataka Health Promotion Trust, Bangalore, India, 24Global Health, Community Empowerment Lab, Lucknow, India, 25Amhara Regional Office, Emory Ethiopia, Bahirdar, Ethiopia, 26Department of Health and Family Welfare, Government of Karnataka, Bangalore, India, 27Centre for Intervention Science in Maternal and Child Health, Universitetet i Bergen Senter for internasjonal helse, Bergen, Norway, 28Division of Epidemiology and Population Health, St. John's Research Institute, St. John's National Academy of Health Sciences, Bangalore, India, 29Private Consultant, Addis Ababa, Ethiopia, 30Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneva, Switzerland, 31Department of Neonatology, St John’s Medical College Hospital, Bangalore, India, 32Global Health, Emory University School of Public Health, Atlanta, Georgia, USA, 33Department of Neonatology, University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada, 34Department of Pediatrics and Child Health, College of Medicine and Health Sciences, Hawassa University, Hawassa, Ethiopia, 35Federal Ministry of Health, Addis Ababa, Ethiopia, 36Maternal and Child Health Directorate, Federal Ministry of Health, Addis Ababa, Ethiopia, 37Pediatrics Society, Addis Ababa, Ethiopia.

      • Contributors Conceptualisation of the study and first drafting of the manuscript: AGG, MLB, LMS, GC, ASE, DHM, HT, BTT, KA, AAM, THA, SM, RU, NB, PKM, SPnR, KJ, ArK, AaK, GD, VK, RB, CP-C, JM. Subsequent revisions of manuscript drafts, completion of information on study settings and methods: JNC, AGG, MLB, BGA, HMA, LMS, GC, ASE, AF, HA, AT, DD, DHM, HT, BTT, AA, HB, BW, MM, TB, NS, KA, AAM, THA, SAB, FAG, MYH, ETL, SM, RU, TKM, AJ, NB, PKM, SPnR, KJ, ArK, MHL, RM, AaK, RK, FNUK, GD, VK, JM, RB. All authors read and approved the final manuscript.

      • Funding The World Health Organization, the sponsor, will fund the study with financial support from the Bill and Melinda Gates Foundation. WHO facilitated the preparation of the protocol, will monitor implementation and analysis of data. It will also facilitate the writing of the report and participate in the decision to submit the report for publication. The study teams will have ultimate authority over any of these activities.

      • Disclaimer The authors alone are responsible for the views expressed in this article and they do not necessarily represent the views, decisions or policies of the institutions with which they are affiliated.

      • Competing interests None declared.

      • Patient consent for publication Not required.

      • Provenance and peer review Not commissioned; externally peer reviewed.