Effectiveness of 4% chlorhexidine umbilical cord care on neonatal mortality in Southern Province, Zambia (ZamCAT): a cluster-randomised controlled trial

Semrau, Katherine; Herlihy, Julie M.; Grogan, Caroline; Musokotwane, Kebby; Yeboah-Antwi, Kojo; Mbewe, Reuben; Banda, Bowen; Mpamba, Chipo; Hamomba, Fern; Pilingana, Portipher; Zulu, Andisen; Chanda‐Kapata, Pascalina; Biemba, Godfrey; Thea, Donald M.; Macleod, W. Bentley; Simon, Jonathon; Hamer, Davidson H.

doi:10.1016/s2214-109x(16)30215-7

Cited by 55 publications

(65 citation statements)

References 17 publications

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“…However, ensuring adequate health workforce has remained a major challenge for health systems of many developing countries such as Kenya [3] and is likely to continue if the use of CHX for cord care is scaled up. In addition, in light of available evidence from randomized controlled trials showing no difference in neonatal mortality between CHX use and dry cord care among facility-based births in some settings [17, 28, 29], the findings of this paper suggest that scaling up the use of CHX should take into account the community context. In particular, the findings indicate that scaling up the use of CHX would be beneficial in settings where application of harmful traditional substances still exist and where mothers are likely to resort to such practices in the absence of acceptable alternatives due to cultural beliefs about birth and newborn care.…”

Section: Discussionmentioning

confidence: 87%

Health care providers’ perspectives regarding the use of chlorhexidine gel for cord care in neonates in rural Kenya: implications for scale-up

Muriuki¹,

Obare

Ayieko³

et al. 2017

BMC Health Serv Res

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BackgroundThis paper explores the perspectives of health care providers regarding the use of 7.1% Chlorhexidine Digluconate (CHX) gel that releases 4% chlorhexidine for newborn umbilical cord care under a managed access program (MAP) implemented in Bungoma County of Kenya. Understanding the perspectives of providers regarding CHX is important since they play a key role in the health system and the fact that their views could be influenced by prior beliefs and inconsistent practices regarding umbilical cord care.MethodsData are from in-depth interviews conducted between April and June 2016 with 39 service providers from 21 facilities that participated in the program. The data were transcribed, typed in Word and analyzed for content. Analysis entailed identifying recurring themes based on the interview guides.ResultsUse of CHX gel for cord care in neonates was acceptable to the health care providers, with all of them supporting scaling up its use throughout the country. Their views were largely influenced by positive outcomes of the medication including fast healing of the cord as reported by mothers, minimal side effects, reduced newborn infections based on what their records showed and mothers’ reports, ease of use that made it simple for them to counsel mothers on how to apply it, positive feedback from mothers which demonstrated satisfaction with the medication, and general acceptance of the medication by the community. They further noted that successful scale-up of the medication required community sensitization, adequate follow-up mechanisms to ensure mothers use the medication correctly, addressing issues of staffing levels and staff training, developing guidelines and protocols for provision of the medication, adopting appropriate service delivery approaches to ensure all groups of mothers are reached, and ensuring constant supply of the medication.ConclusionUse of CHX gel for cord care in neonates is likely to be acceptable to health care workers in settings with high prevalence of neonatal morbidity and mortality arising from cord infections. In scaling up the use of the medication in such settings, some of the health systems requirements for successful roll-out can be addressed by programs while others are likely to be a persistent challenge.

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Section: Discussionmentioning

confidence: 87%

Health care providers’ perspectives regarding the use of chlorhexidine gel for cord care in neonates in rural Kenya: implications for scale-up

Muriuki¹,

Obare

Ayieko³

et al. 2017

BMC Health Serv Res

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“…But results of the effect of 4% CHX applied to the umbilical cord stump on neonatal mortality in the three Asian trials are incongruent with findings in the two African trials. While all studies report an effect of 4% CHX on omphalitis, the African trials [9, 10] did not find an effect on neonatal mortality, unlike the Asian trials [6–8]. Moreover, none of these studies, particularly the African trials report on the potential effect of CHX on severe illness.…”

Section: Discussionmentioning

confidence: 99%

“…There is a sufficient state of equipoise in Sub-Saharan Africa to justify this study because this intervention has never been tested, and only one study in Asia shows the effect of a single CHX application. Furthermore, two African trials [9, 10] that did not report on severe illness, found no effect of CHX on neonatal mortality, unlike the three Asian trials [6–8]. …”

Section: Ethics and Disseminationmentioning

confidence: 99%

Efficacy of umbilical cord cleansing with a single application of 4% chlorhexidine for the prevention of newborn infections in Uganda: study protocol for a randomized controlled trial

Nankabirwa

Tylleskär

Tumuhamye

et al. 2017

Trials

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BackgroundYearly, nearly all the estimated worldwide 2.7 million neonatal deaths occur in low- and middle-income countries. Infections, including those affecting the umbilical cord (omphalitis), are a significant factor in approximately a third of these deaths. In fact, the odds of all-cause mortality are 46% higher among neonates with omphalitis than in those without. Five large randomized controlled trials in Asia and Sub-Saharan Africa (SSA) have examined the effect of multiple cord stump applications with 4% chlorhexidine (CHX) for at least 7 days on the risk of omphalitis and neonatal death. These studies, all community-based, show that multiple CHX applications reduced the risk of omphalitis. Of these trials, only one study from South Asia (the Bangladeshi study) and none from Africa examined the effect of a single application of CHX as soon as possible after birth. In this Bangladeshi trial, CHX led to a reduction in the risk of mild-moderate omphalitis and neonatal death. It is important, in an African setting, to explore the effect of a single application among health-facility births. A single application is programmatically much simpler to implement than daily applications for 7 days. Therefore, our study compares umbilical cord cleansing with a single application of 4% CHX at birth with dry cord care among Ugandan babies born in health facilities, on the risk of omphalitis and severe neonatal illness.MethodsThe CHX study is a facility-based, individually randomized controlled trial that will be conducted among 4760 newborns in Uganda. The primary outcomes are severe illness and omphalitis during the neonatal period. Analysis will be by intention-to-treat.DiscussionThis study will provide novel evidence, from a Sub-Saharan African setting, of the effect of umbilical cord cleansing with a single application of 4% CHX at birth and identify modifiable risk factors for omphalitis.Trial registrationClinicalTrials.gov, identifier: NCT02606565. Registered on 12 November 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2050-0) contains supplementary material, which is available to authorized users.

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“…These updated guidelines focused on home births because the South Asian trials that formed the basis of new recommendations were dominated by home births (>90%)[2-4] and the neonatal mortality rate (NMR) in those trials exceeded 30/1000. Two recent studies [5,6] in substantially lower risk settings in Tanzania and Zambia (NMR <11/1000 and <15/1000, respectively) provided no evidence that the intervention would improve survival in settings where mortality was already low. In high-mortality settings, however, policymakers need further guidance on whether or not to extend their emerging chlorhexidine cleansing programs to facility births.…”

Section: Introductionmentioning

confidence: 99%

Impact of Chlorhexidine Cord Cleansing on Mortality, Omphalitis and Cord Separation Time Among Facility-Born Babies in Nepal and Bangladesh

Mullany

Arifeen

Khatry³

et al. 2017

Pediatric Infectious Disease Journal

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Guidance is needed regarding potential extension of the WHO recommendation for cord cleansing with chlorhexidine to babies born in facilities. Among 3,223 facility-born babies from Nepal and Bangladesh, mortality was approximately halved among those allocated to the intervention clusters (10.5/1000 vs. 19.4/1000, RR=0.54; 95% CI: 0.30 – 0.97). In high-mortality settings, a single policy for home and facility births is warranted.

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Effectiveness of 4% chlorhexidine umbilical cord care on neonatal mortality in Southern Province, Zambia (ZamCAT): a cluster-randomised controlled trial

Abstract: Bill & Melinda Gates Foundation.

Cited by 55 publications

References 17 publications

Health care providers’ perspectives regarding the use of chlorhexidine gel for cord care in neonates in rural Kenya: implications for scale-up

Health care providers’ perspectives regarding the use of chlorhexidine gel for cord care in neonates in rural Kenya: implications for scale-up

Efficacy of umbilical cord cleansing with a single application of 4% chlorhexidine for the prevention of newborn infections in Uganda: study protocol for a randomized controlled trial

Impact of Chlorhexidine Cord Cleansing on Mortality, Omphalitis and Cord Separation Time Among Facility-Born Babies in Nepal and Bangladesh

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