{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T17:32:53Z","timestamp":1788197573178,"version":"build-2803163510"},"reference-count":26,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2020,3,19]],"date-time":"2020-03-19T00:00:00Z","timestamp":1584576000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2020,3,19]],"date-time":"2020-03-19T00:00:00Z","timestamp":1584576000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["Investment ID OPP 1151718"],"award-info":[{"award-number":["Investment ID OPP 1151718"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Globally, about 15% of newborns are born with a low birth weight (LBW) as a result of preterm birth or intrauterine growth restriction or both. Up to 70% of neonatal deaths occur in this group within the first 3 days after birth. Kangaroo Mother Care (KMC) applied after stabilization of the infant has been shown to reduce mortality by 40% among hospitalized infants with a birth weight of less than 2.0\u2009kg. In these studies, infants were randomly assigned and KMC was initiated after about 3 days of age, when the majority of neonatal deaths would have already occurred. The aim of this trial is to evaluate the safety and efficacy of continuous KMC initiated as soon as possible after birth compared with the current recommendation of initiating continuous KMC after stabilization in neonates with a birth weight between 1.0 and less than 1.8\u2009kg.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This randomized controlled trial is being conducted in tertiary-care hospitals in five low- to middle-income countries (LMICs) in South Asia and sub-Saharan Africa. All pregnant women admitted to these hospitals for childbirth are pre-screened. After delivery, all neonates with a birth weight between 1.0 and less than 1.8\u2009kg are screened for enrollment. Eligible infants are randomly assigned to intervention and control groups. The intervention consists of continuous skin-to-skin contact initiated as soon as possible after birth, promotion and support for early exclusive breastfeeding, and provision of health care for mother and baby with as little separation as possible. This efficacy trial will primarily evaluate the impact of KMC started immediately after birth on neonatal death (between enrollment and 72\u2009h of age and deaths between enrollment and 28\u2009days of age) and other key outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>This is the first large multi-country trial studying immediate KMC in LMICs. Implementation of this intervention has already resulted in an important enhancement of the paradigm shift in LMIC settings in which mothers are not separated from their baby in neonatal intensive care units (NICUs). The findings of this trial will have future global implications not only on how the LBW newborns are cared for immediately after birth but also for the dissemination of designing NICUs in accordance with the mother-neonatal intensive care unit (M-NICU) model.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      Clinical Trials Registry - India (CTRI): CTRI\/2018\/08\/01536 (retrospectively registered); Australian New Zealand Clinical Trials Registry (ANZCTR):\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/anzctr.org.au\/ACTRN12618001880235.aspx\">ACTRN12618001880235<\/jats:ext-link>\n                      (retrospectively registered).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-020-4101-1","type":"journal-article","created":{"date-parts":[[2020,3,18]],"date-time":"2020-03-18T20:04:36Z","timestamp":1584561876000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":42,"title":["Impact of continuous Kangaroo Mother Care initiated immediately after birth (iKMC) on survival of newborns with birth weight between 1.0 to &lt; 1.8\u2009kg: study protocol for a randomized controlled trial"],"prefix":"10.1186","volume":"21","author":[{"name":"WHO Immediate KMC Study Group","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,3,19]]},"reference":[{"key":"4101_CR1","volume-title":"Low birth weight: country, regional and global estimates","author":"World Health Organization & United Nations Children\u2019s Fund (UNICEF)","year":"2004","unstructured":"World Health Organization & United Nations Children\u2019s Fund (UNICEF). 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Acta Paediatr. 2016;105(4):381\u201390.","journal-title":"Acta Paediatr"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-020-4101-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s13063-020-4101-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-020-4101-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,3,18]],"date-time":"2021-03-18T20:32:08Z","timestamp":1616099528000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-020-4101-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,3,19]]},"references-count":26,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2020,12]]}},"alternative-id":["4101"],"URL":"https:\/\/doi.org\/10.1186\/s13063-020-4101-1","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.2.19775\/v1","asserted-by":"object"},{"id-type":"doi","id":"10.21203\/rs.2.19775\/v2","asserted-by":"object"}]},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,3,19]]},"assertion":[{"value":"17 December 2019","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"21 January 2020","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"19 March 2020","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The study protocol is approved by the WHO Ethics Review Committee (reference number: EC0002910 approved on 6 October 2017). Approvals on the same protocol were also obtained from local institutional review boards in the five sites: Ghana\u2019s School of Medical Science\/Komfo Anokye Teaching Hospital (reference number: CHRPE\/AP\/372\/17, initial approval on 30 June 2017), Tanzania\u2019s National Institute for Medical research (reference number: NIMR\/HQ\/R.8a\/Vol. IX\/2621, initial approval on 6 November 2017), Malawi\u2019s College of Medicine Research and Ethics Committee (COMREC) (reference number: P.08\/17\/2235, initial approval on 27 September 2017), Nigeria\u2019s OAUTHC Ethics and Research Committee (reference number: IRB\/IEC\/0004553 NHREC\/27\/02\/2009a, initial approval on 12 July 2017), Institute of Ethics Committee of VMMC & Safdarjung Hospital (reference number: IEC\/SJH\/VMMC\/Project\/August-2017, initial approval on 24 August 2017). Each updated version of the approved protocol will be submitted to the ethics committees above.Written informed consent is taken by study staff from admitted pregnant women who are identified to be at high risk of delivering an LBW infant. The participants\u2019 confidentiality is maintained throughout the trial in line with the standard International Conference on Harmonization - Good Clinical Practice (ICH-GCP) principles. The consent form includes consent for participation in the trial and also for sharing of data with researchers. This study does not involve collection of biological specimens. The consent forms are held by the study teams at the five sites and are available for review by the Editor-in-Chief of this journal.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"280"}}