Top

BMC Pediatrics

Published in:

Open Access 01-12-2021 | Autopsy | Study protocol

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

Authors: Kaajal Patel, Sopheakneary Say, Daly Leng, Manila Prak, Koung Lo, Mavuto Mukaka, Arthur Riedel, Claudia Turner

Published in: BMC Pediatrics | Issue 1/2021

Abstract

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.

Available only for authorised users

United Nations Inter-agency Group for Child Mortality Estimation (UN, IGME). Levels and Trends in Child Mortality: Report 2018, Estimates developed by the United Nations Inter-agency Group for Child Mortality Estimation; 2018. [cited 2018 Nov 22]. Available from: https://data.unicef.org/wp-content/uploads/2018/10/Child-Mortality-Report-2018.pdf.

National Institute of Statistics, Directorate General for Health, ICF International. Cambodia Demographic and Health Survey 2014. 2015. [cited 2018 Jan 16]. Available from: https://dhsprogram.com/pubs/pdf/fr312/fr312.pdf.

Lawn JE, Blencowe H, Oza S, You D, Lee ACC, Waiswa P, et al. Every newborn: progress, priorities, and potential beyond survival. Lancet. 2014;384(9938):189–205. [cited 2018 Sep 4]. Available from: https://doi.org/10.1016/S0140-6736(14)60496-7.

Bhutta ZA, Das JK, Bahl R, Lawn JE, Salam RA, Paul VK, et al. Can available interventions end preventable deaths in mothers, newborn babies, and stillbirths, and at what cost? Lancet. 2014;384(9940):347–70. [cited 2018 Sep 6]. Available from: https://doi.org/10.1016/S0140-6736(14)60792-3.

Darmstadt GL, Kinney MV, Chopra M, Cousens S, Kak L, Paul VK, et al. Who has been caring for the baby? Lancet. 2014;384(9938):174–88. [cited 2018 Sep 6]. Available from: https://doi.org/10.1016/S0140-6736(14)60458-X.

Dickson KE, Simen-Kapeu A, Kinney MV, Huicho L, Vesel L, Lackritz E, et al. Every newborn: health-systems bottlenecks and strategies to accelerate scale-up in countries. Lancet. 2014;384(9941):438–54. [cited 2018 Sep 6]. Available from: https://doi.org/10.1016/S0140-6736(14)60582-1.

Bellad RM, Bang A, Carlo WA, McClure EM, Meleth S, Goco N, et al. A pre-post study of a multi-country scale up of resuscitation training of facility birth attendants: does helping babies breathe training save lives? BMC Pregnancy Childbirth. 2016;16(1):222 Available from: https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-016-0997-6.CrossRef

Theobald S, Brandes N, Gyapong M, El-Saharty S, Proctor E, Diaz T, et al. Implementation research: new imperatives and opportunities in global health. Lancet. 2018;392(10160):2214–28. [cited 2019 Mar 25]. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0140673618322050.

Alonge O, Rodriguez DC, Brandes N, Geng E, Reveiz L, Peters DH. How is implementation research applied to advance health in low-income and middle-income countries? BMJ Glob Health. 2019;4(2):e001257. [cited 2020 Jul 28]. Available from: http://gh.bmj.com/lookup/doi/10.1136/bmjgh-2018-001257.

10.

Pai M, Schumacher SG, Abimbola S. Surrogate endpoints in global health research: still searching for killer apps and silver bullets? BMJ Glob Health. 2018;3(2):e000755 [cited 2020 Jul 3]. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5873542/.CrossRef

11.

Wrammert J, Kc A, Ewald U, Målqvist M. Improved postnatal care is needed to maintain gains in neonatal survival after the implementation of the helping babies breathe initiative. Acta Paediatr. 2017;106(8):1280–5 [cited 2020 Aug 6]. Available from: https://pubmed.ncbi.nlm.nih.gov/28316097/.CrossRef

12.

Kruk ME, Gage AD, Arsenault C, Jordan K, Leslie HH, Roder-DeWan S, et al. High-quality health systems in the sustainable development goals era: time for a revolution. Lancet Glob Health. 2018;6(11):e1196–252. [cited 2018 Sep 18]. Available from: https://linkinghub.elsevier.com/retrieve/pii/S2214109X18303863.

13.

Colbourn T, Nambiar B, Bondo A, Makwenda C, Tsetekani E, Makonda-Ridley A, et al. Effects of quality improvement in health facilities and community mobilization through women’s groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial. Int Health. 2013;5(3):180–95. [cited 2020 Aug 6]. Available from: https://academic.oup.com/inthealth/article-lookup/doi/10.1093/inthealth/iht011.

14.

Lassi ZS, Bhutta ZA. Community-based intervention packages for reducing maternal and neonatal morbidity and mortality and improving neonatal outcomes. Cochrane Database Syst Rev. 2015;2015(3):CD007754 [cited 2018 Sep 17]. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25803792.

15.

Knippenberg R, Lawn JE, Darmstadt GL, Begkoyian G, Fogstad H, Walelign N, et al. Systematic scaling up of neonatal care in countries. Lancet. 2005;365(9464):1087–98 [cited 2018 Sep 7]. Available from: http://linkinghub.elsevier.com/retrieve/pii/S0140673605711454.CrossRef

16.

Prost A, Colbourn T, Seward N, Azad K, Coomarasamy A, Copas A, et al. Women’s groups practising participatory learning and action to improve maternal and newborn health in low-resource settings: a systematic review and meta-analysis. Lancet. 2013;381(9879):1736–46 [cited 2019 Oct 22]. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0140673613606856.CrossRef

17.

Tripathy P, Nair N, Barnett S, Mahapatra R, Borghi J, Rath S, et al. Effect of a participatory intervention with women’s groups on birth outcomes and maternal depression in Jharkhand and Orissa, India: a cluster-randomised controlled trial. Lancet. 2010;375(9721):1182–92. [cited 2020 Aug 30]. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0140673609620420.

18.

Lewycka S, Mwansambo C, Rosato M, Kazembe P, Phiri T, Mganga A, et al. Effect of women’s groups and volunteer peer counselling on rates of mortality, morbidity, and health behaviours in mothers and children in rural Malawi (MaiMwana): a factorial, cluster-randomised controlled trial. Lancet. 2013;381(9879):1721–35 [cited 2020 Aug 6]. Available from: https://pubmed.ncbi.nlm.nih.gov/23683639/.CrossRef

19.

Azad K, Barnett S, Banerjee B, Shaha S, Khan K, Rego AR, et al. Effect of scaling up women’s groups on birth outcomes in three rural districts in Bangladesh: a cluster-randomised controlled trial. Lancet. 2010;375(9721):1193–202 [cited 2020 Aug 6]. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0140673610601420.CrossRef

20.

Manandhar DS, Osrin D, Shrestha BP, Mesko N, Morrison J, Tumbahangphe KM, et al. Effect of a participatory intervention with women’s groups on birth outcomes in Nepal: cluster-randomised controlled trial. Lancet. 2004;364(9438):970–9 [cited 2020 Aug 6]. Available from: https://pubmed.ncbi.nlm.nih.gov/15364188/.CrossRef

21.

World Health Organisation. WHO recommendation on community mobilization through facilitated participatory learning and action cycles with women’s groups for maternal and newborn health [Internet]. WHO. 2014. [cited 2020 Aug 30]. Available from: http://apps.who.int/iris/bitstream/10665/127939/1/9789241507271_eng.pdf?ua=1

22.

Lim SS, Dandona L, Hoisington JA, James SL, Hogan MC, Gakidou E. India’s Janani Suraksha Yojana, a conditional cash transfer programme to increase births in health facilities: an impact evaluation. Lancet. 2010;375(9730):2009–23 [cited 2020 Sep 6]. Available from: https://linkinghub.elsevier.com/retrieve/pii/S0140673610607441.CrossRef

23.

Larson E, Mbaruku G, Mbatia R, Gage A, Haneuse S, Kruk M. Can investment in quality drive use? A cluster-randomised controlled study in rural Tanzania. Lancet Glob Health. 2018;6:S9. [cited 2020 Feb 9]. Available from: https://linkinghub.elsevier.com/retrieve/pii/S2214109X18301384.

24.

Wall SN, Lee AC, Niermeyer S, English M, Keenan WJ, Carlo W, et al. Neonatal resuscitation in low-resource settings: what, who, and how to overcome challenges to scale up? Int J Gynecol Obstet. 2009;107(supplement):S47–64. [cited 2019 Feb 25]. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19815203.CrossRef

25.

Vasan A, Mabey DC, Chaudhri S, Brown Epstein H-A, Lawn SD. Support and performance improvement for primary health care workers in low- and middle-income countries: a scoping review of intervention design and methods. Health Policy Plan. 2016;32(3):437–52. [cited 2019 Feb 21]. Available from: https://doi.org/10.1093/heapol/czw144.

26.

Schwerdtle P, Morphet J, Hall H. A scoping review of mentorship of health personnel to improve the quality of health care in low and middle-income countries. Glob Health. 2017;13(1):77. [cited 2018 Nov 12]. Available from: https://doi.org/10.1186/s12992-017-0301-1.

27.

Rowe AK, Rowe SY, Peters DH, Holloway KA, Chalker J, Ross-Degnan D. Effectiveness of strategies to improve health-care provider practices in low-income and middle-income countries: a systematic review. Lancet Glob Health. 2018;6(11):e1163–75. https://doi.org/10.1016/S2214-109X(18)30398-X.CrossRefPubMedPubMedCentral

28.

Jha P. Reliable direct measurement of causes of death in low- and middle-income countries. BMC Med. 2014;12(1):19 [cited 2020 Apr 24]. Available from: http://bmcmedicine.biomedcentral.com/articles/10.1186/1741-7015-12-19.CrossRef

29.

Ozano K, Simkhada P, Thann K, Khatri R. Improving local health through community health workers in Cambodia: challenges and solutions. Hum Resour Health. 2018;16(1):2 [cited 2018 Sep 7]. Available from: http://www.ncbi.nlm.nih.gov/pubmed/29304869.CrossRef

30.

Fox-Lewis S, Genasci Smith W, Lor V, McKellar G, Phal C, Fox-Lewis A, et al. Get the basics right: a description of the key priorities for establishing a neonatal Service in a Resource-Limited Setting in Cambodia. J Trop Pediatr. 2019;65(2):160–8. [cited 2018 Jul 25]. Available from: https://doi.org/10.1093/tropej/fmy030.

31.

Turner C, Carrara V, Aye Mya Thein N, Chit Mo Mo Win N, Turner P, Bancone G, et al. Neonatal intensive Care in a Karen Refugee Camp: a 4 year descriptive study. Kollmann TR, editor. PLoS One. 2013;8(8):e72721. [cited 2018 Sep 4]. Available from: https://dx.plos.org/10.1371/journal.pone.0072721.

32.

Saving Babies’ Lives. [cited 2021 Feb 12]. Available from: https://angkorhospital.shinyapps.io/SBLP/

33.

World Health Organization. Verbal Autopsy Standards: The 2016 WHO verbal autopsy instrument. Manual for the training of interviewers on the use of the 2016 WHO VA instrument. 2017. Available from: https://www.who.int/standards/classifications/other-classifications/verbal-autopsy-standards-ascertaining-and-attributing-causes-of-death-tool.

34.

World Health Organisation. WHO | Verbal autopsy standards: ascertaining and attributing causes of death [Internet]. WHO. World Health Organization; 2016. [cited 2020 Sep 6]. Available from: http://www.who.int/healthinfo/statistics/verbalautopsystandards/en/

35.

Allanson E, Tunçalp Ö, Gardosi J, Pattinson RC, Erwich JJHM, Flenady VJ, et al. Classifying the causes of perinatal death. Bull World Health Organ. 2016;94(2):79–79A. https://doi.org/10.2471/BLT.15.168047.CrossRefPubMedPubMedCentral

36.

World Health Organisation. The WHO application of ICD-10 to deaths during the perinatal period: ICD-PM [Internet]. World Health Organization. 2016. Available from: http://www.who.int/reproductivehealth/projects/02-ICD-PM.pdf?ua=1.

37.

Waiswa P, Kallander K, Peterson S, Tomson G, Pariyo GW. Using the three delays model to understand why newborn babies die in eastern Uganda. Tropical Med Int Health. 2010;15(8):964–72. [cited 2018 Sep 4]. Available from:. https://doi.org/10.1111/j.1365-3156.2010.02557.x.CrossRef

38.

Kalter HD, Salgado R, Babille M, Koffi AK, Black RE. Social autopsy for maternal and child deaths: a comprehensive literature review to examine the concept and the development of the method. Popul Health Metrics. 2011;9(1):45 [cited 2020 Jan 29]. Available from: http://www.pophealthmetrics.com/content/9/1/45.CrossRef

39.

Moyer CA, Johnson C, Kaselitz E, Aborigo R. Using social autopsy to understand maternal, newborn, and child mortality in low-resource settings: a systematic review of the literature. Glob Health Action. 2017;10(1):1413917. Available from: [cited 2020 Feb 9]. https://www.tandfonline.com/doi/full/10.1080/16549716.2017.1413917.

40.

Thaddeus S, Maine D. Too far to walk: maternal mortality in context. Soc Sci Med. 1994;38(8):1091–110. Available from: https://doi.org/10.1016/0277-9536(94)90226-7.

41.

Marston C, Renedo A, CR MG, Portela A. Effects of community participation on improving uptake of skilled Care for Maternal and Newborn Health: a systematic review. Braitstein P, editor. PLoS One. 2013;8(2):e55012 [cited 2020 Aug 6]. Available from: https://pubmed.ncbi.nlm.nih.gov/23390509/.CrossRef

42.

World Health Organisation. Advocacy, communication and social mobilization for TB control: A Guide To Developing Knowledge, Attitude and Practice Surveys [Internet]. World Health Organisation. 2008. [cited 2020 Aug 30]. Available from: https://apps.who.int/iris/handle/10665/43790.

43.

Moore G, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process Evaluation of Complex Interventions: UK Medical Research (MRC) Guideline [Internet]. MRC Population Health Science Research Network. 2014. [cited 2019 Mar 13]. Available from: https://www.mrc.ac.uk/documents/pdf/mrc-phsrn-process-evaluation-guidance-final/.

44.

Grant A, Treweek S, Dreischulte T, Foy R, Guthrie B. Process evaluations for cluster-randomised trials of complex interventions: a proposed framework for design and reporting. Trials. 2013;14(1):15 [cited 2019 Oct 22]. Available from: http://www.trialsjournal.com/content/14/1/15.CrossRef

45.

Woertman W, De Hoop E, Moerbeek M, Zuidema SU, Gerritsen DL, Teerenstra S. Stepped wedge designs could reduce the required sample size in cluster randomized trials. J Clin Epidemiol. 2013;66:752–8. [cited 2020 Oct 23]. https://doi.org/10.1016/j.jclinepi.2013.01.009.CrossRef

46.

R: The R Project for Statistical Computing [Internet]. [cited 2020 Aug 30]. Available from: https://www.r-project.org/

47.

Hemming K, Taljaard M, McKenzie JE, Hooper R, Copas A, Thompson JA, et al. Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ. 2018;363:k1614. [cited 2019 Mar 28]. Available from: https://doi.org/10.1136/bmj.k1614.

48.

Barker D, McElduff P, D’Este C, Campbell MJ. Stepped wedge cluster randomised trials: a review of the statistical methodology used and available. BMC Med Res Methodol. 2016;16(1):69 [cited 2020 Jul 27]. Available from: http://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-016-0176-5.CrossRef

49.

Houweling TAJ, Looman CWN, Azad K, Das S, King C, Kuddus A, et al. The equity impact of community women’s groups to reduce neonatal mortality: a meta-analysis of four cluster randomized trials. Int J Epidemiol. 2019;48(1):168–82 [cited 2020 Aug 6]. Available from: https://academic.oup.com/ije/article/48/1/168/4093960.CrossRef

50.

Houweling TAJ, Morrison J, Azad K, Manandhar DS, Alcock G, Shende S, et al. How to reach every newborn: three key messages. Lancet Glob Health. 2014;2(8):e436–7 [cited 2020 Aug 6]. Available from: https://pubmed.ncbi.nlm.nih.gov/25103506/.CrossRef

51.

Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200. [cited 2021 Feb 12]. Available from: http://annals.org/article.aspx?doi=10.7326/0003-4819-158-3-201302050-00583.

52.

Ashish KC, Gurung R, Kinney MV, Sunny AK, Moinuddin M, Basnet O, et al. Effect of the COVID-19 pandemic response on intrapartum care, stillbirth, and neonatal mortality outcomes in Nepal: a prospective observational study. Lancet Glob Health. 2020;8(10):e1273–81. [cited 2020 Nov 3]. Available from: https://linkinghub.elsevier.com/retrieve/pii/S2214109X20303454.

53.

Graham WJ, Afolabi B, Benova L, Campbell OMR, Filippi V, Nakimuli A, et al. Protecting hard-won gains for mothers and newborns in low-income and middle-income countries in the face of COVID-19: call for a service safety net. BMJ Glob Health. 2020;5(6):e002754. [cited 2020 Jun 17]. Available from: http://gh.bmj.com/lookup/doi/10.1136/bmjgh-2020-002754.

Title: Saving babies’ lives (SBL) – a programme to reduce neonatal mortality in rural Cambodia: study protocol for a stepped-wedge cluster-randomised trial
Authors: Kaajal Patel
Sopheakneary Say
Daly Leng
Manila Prak
Koung Lo
Mavuto Mukaka
Arthur Riedel
Claudia Turner
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Autopsy
Care
Published in: BMC Pediatrics / Issue 1/2021
Electronic ISSN: 1471-2431
DOI: https://doi.org/10.1186/s12887-021-02833-7

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2021

Neurobehavioural and cognitive effects of prenatal exposure to organochlorine compounds in three year old children

Successful rescue of a lethal Griscelli syndrome type 2 presenting with neurological involvement and hemophagocytic lymphohistiocytosis: a case report

Nutritional status and associated factors among children with congenital heart disease in selected governmental hospitals and cardiac center,Addis Ababa Ethiopia

Factors affecting rehabilitation of infants with Central Coordination Disorders during a three-month-long observation

Tinea capitis in an immigrant pediatric community; a clinical signs-based treatment approach

CASP5 and CR1 as potential biomarkers for Kawasaki disease: an Integrated Bioinformatics-Experimental Study