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Background: Neonatal mortality remains unacceptably high. Many studies successful at reducing neonatal mortality have failed to realise similar gains at scale. Effective implementation and scale-up of interventions designed to tackle neonatal mortality is a global health priority. Multifaceted programmes targeting the continuum of neonatal care, with sustainability and scalability built into the design, can provide practical insights to solve this challenge. Cambodia has amongst the highest neonatal mortality rates in South-East Asia, with rural areas particularly affected. The primary objective of this study is the design, implementation, and assessment of the Saving Babies' Lives programme, a package of interventions designed to reduce neonatal mortality in rural Cambodia.

Methods: This study is a five-year stepped-wedge cluster-randomised trial conducted in a rural Cambodian province with an estimated annual delivery rate of 6615. The study is designed to implement and evaluate the Saving Babies' Lives programme, which is the intervention. The Saving Babies' Lives programme is an iterative package of neonatal interventions spanning the continuum of care and integrating into the existing health system. The Saving Babies' Lives programme comprises two major components: participatory learning and action with community health workers, and capacity building of primary care facilities involving facility-based mentorship. Standard government service continues in control arms. Data collection covering the whole study area includes surveillance of all pregnancies, verbal and social autopsies, and quality of care surveys. Mixed methods data collection supports iteration of the complex intervention, and facilitates impact, outcome, process and economic evaluation.

Discussion: Our study uses a robust study design to evaluate and develop a holistic, innovative, contextually relevant and sustainable programme that can be scaled-up to reduce neonatal mortality.

Trial Registration: ClinicalTrials.gov: NCT04663620 . Registered on 11th December 2020, retrospectively registered.

Titel:	Saving babies' lives (SBL) - a programme to reduce neonatal mortality in rural Cambodia: study protocol for a stepped-wedge cluster-randomised trial.
Autor/in / Beteiligte Person:	Patel, K ; Say, S ; Leng, D ; Prak, M ; Lo, K ; Mukaka, M ; Riedel, A ; Turner, C
Link:	Zum Volltext
Zeitschrift:	BMC pediatrics, Jg. 21 (2021-09-07), Heft 1, S. 390
Veröffentlichung:	London : BioMed Central, [2001-, 2021
Medientyp:	academicJournal
ISSN:	1471-2431 (electronic)
DOI:	10.1186/s12887-021-02833-7
Schlagwort:	Cambodia Community Health Workers Delivery of Health Care Female Humans Infant Infant, Newborn Pregnancy Randomized Controlled Trials as Topic Infant Mortality Rural Population
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Publication Type: Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't Language: English [BMC Pediatr] 2021 Sep 07; Vol. 21 (1), pp. 390. <i>Date of Electronic Publication: </i>2021 Sep 07. MeSH Terms: Infant Mortality* ; Rural Population* ; Cambodia ; Community Health Workers ; Delivery of Health Care ; Female ; Humans ; Infant ; Infant, Newborn ; Pregnancy ; Randomized Controlled Trials as Topic References: Lancet. 2005 Mar 19-25;365(9464):1087-98. (PMID: 15781104) ; Lancet. 2018 Nov 17;392(10160):2214-2228. (PMID: 30314860) ; Lancet. 2014 Jul 26;384(9940):347-70. (PMID: 24853604) ; Soc Sci Med. 1994 Apr;38(8):1091-110. (PMID: 8042057) ; BMC Med Res Methodol. 2016 Jun 06;16:69. (PMID: 27267471) ; Cochrane Database Syst Rev. 2015 Mar 23;(3):CD007754. (PMID: 25803792) ; BMC Pregnancy Childbirth. 2016 Aug 15;16(1):222. (PMID: 27527831) ; BMJ Glob Health. 2019 Mar 7;4(2):e001257. (PMID: 30997169) ; BMJ Glob Health. 2020 Jun;5(6):. (PMID: 32499220) ; BMJ. 2018 Nov 9;363:k1614. (PMID: 30413417) ; Lancet. 2013 May 18;381(9879):1736-46. (PMID: 23683640) ; Lancet. 2010 Apr 3;375(9721):1193-202. (PMID: 20207412) ; BMJ Glob Health. 2018 Mar 8;3(2):e000755. (PMID: 29607104) ; Bull World Health Organ. 2016 Feb 1;94(2):79-79A. (PMID: 26908954) ; Lancet Glob Health. 2020 Oct;8(10):e1273-e1281. (PMID: 32791117) ; Global Health. 2017 Oct 3;13(1):77. (PMID: 28974233) ; J Clin Epidemiol. 2013 Jul;66(7):752-8. (PMID: 23523551) ; Trop Med Int Health. 2010 Aug;15(8):964-72. (PMID: 20636527) ; Int Health. 2013 Sep;5(3):180-95. (PMID: 24030269) ; Lancet. 2010 Apr 3;375(9721):1182-92. (PMID: 20207411) ; Health Policy Plan. 2017 Apr 1;32(3):437-452. (PMID: 27993961) ; Hum Resour Health. 2018 Jan 6;16(1):2. (PMID: 29304869) ; BMC Med. 2014 Feb 04;12:19. (PMID: 24495839) ; Int J Gynaecol Obstet. 2009 Oct;107 Suppl 1:S47-62, S63-4. (PMID: 19815203) ; Lancet. 2014 Jul 12;384(9938):174-88. (PMID: 24853603) ; Lancet Glob Health. 2014 Aug;2(8):e436-7. (PMID: 25103506) ; Lancet. 2004 Sep 11-17;364(9438):970-9. (PMID: 15364188) ; Int J Epidemiol. 2019 Feb 1;48(1):168-182. (PMID: 29024995) ; Lancet. 2014 Jul 12;384(9938):189-205. (PMID: 24853593) ; Lancet Glob Health. 2018 Nov;6(11):e1163-e1175. (PMID: 30309799) ; Trials. 2013 Jan 12;14:15. (PMID: 23311722) ; Glob Health Action. 2017;10(1):1413917. (PMID: 29261449) ; Acta Paediatr. 2017 Aug;106(8):1280-1285. (PMID: 28316097) ; PLoS One. 2013;8(2):e55012. (PMID: 23390509) ; Lancet. 2014 Aug 2;384(9941):438-54. (PMID: 24853600) ; PLoS One. 2013 Aug 22;8(8):e72721. (PMID: 23991145) ; Popul Health Metr. 2011 Aug 05;9:45. (PMID: 21819605) ; J Trop Pediatr. 2019 Apr 1;65(2):160-168. (PMID: 29846731) ; Ann Intern Med. 2013 Feb 5;158(3):200-7. (PMID: 23295957) ; Lancet Glob Health. 2018 Nov;6(11):e1196-e1252. (PMID: 30196093) ; Lancet. 2010 Jun 5;375(9730):2009-23. (PMID: 20569841) ; Lancet. 2013 May 18;381(9879):1721-35. (PMID: 23683639) Contributed Indexing: Keywords: Cambodia; Cluster-randomised; Community health worker; Health system; Healthcare worker; Implementation; Mentorship; Neonatal mortality; Participatory learning and action; Stepped-wedge Molecular Sequence: ClinicalTrials.gov NCT04663620 Entry Date(s): Date Created: 20210908 Date Completed: 20210913 Latest Revision: 20231107 Update Code: 20240513 PubMed Central ID: PMC8421466

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Saving babies' lives (SBL) - a programme to reduce neonatal mortality in rural Cambodia: study protocol for a stepped-wedge cluster-randomised trial.