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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.

ABSTRACT: Yearly, 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.The 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.This 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.ClinicalTrials.gov, identifier: NCT02606565 . Registered on 12 November 2015.

SUBMITTER: Nankabirwa V

PROVIDER: S-EPMC5508681 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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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 Victoria V Tylleskär Thorkild T Tumuhamye Josephine J Tumwine James K JK Ndeezi Grace G Martines José C JC Sommerfelt Halvor H

Trials 20170712 1

<h4>Background</h4>Yearly, 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 ...[more]

PMID: 28701228

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Project description:We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy of chlorhexidine application to the umbilical cord in neonates. We searched MEDLINE and other electronic databases, and included all RCTs that evaluated the effect of single or multiple chlorhexidine cord applications on the neonatal mortality rate (NMR) and/or the incidence of systemic sepsis and omphalitis. A total of six RCTs-four community-based cluster RCTs and two hospital-based trials-were included in the review. Of the four cluster RCTs, three were conducted in South Asia in settings with high rates of home births (>92%) while the fourth, available only as an abstract, was conducted in Africa. Pooled analysis by the 'intention-to-treat' principle showed a significant reduction in NMR after chlorhexidine application (four studies; relative risk (RR) 0.85; 95% confidence interval (CI) 0.76 to 0.95; fixed effects (FE) model). On subgroup analysis, only multiple applications showed a significant effect (four studies; RR 0.88; 95% CI 0.78 to 0.99) whereas a single application did not (one study; RR 0.86; 0.73 to 1.02). Similarly, only the community-based trials showed a significant reduction in NMR (three studies; RR 0.86; 95% CI 0.77 to 0.95), while the hospital-based study did not find any effect (RR 0.11; 0.01 to 2.03). Since all the studies were conducted in high-NMR settings (?30 per 1000 live births), we could not determine the effect in settings with low NMRs. Only one study-a hospital-based trial from India-reported the incidence of neonatal sepsis; it did not find a significant reduction in any sepsis (RR 0.67; 95% CI 0.35 to 1.28). Pooled analysis of community-based studies revealed significant reduction in the risk of omphalitis in infants who received the intervention (four studies; RR 0.71; 95% CI 0.62 to 0.81). The hospital-based trial had no instances of omphalitis in either of the two groups. Chlorhexidine application delayed the time to cord separation (four studies; mean difference 2.11 days; 95% CI 2.07 to 2.15; FE model). Chlorhexidine application to the cord reduces the risk of neonatal mortality and omphalitis in infants born at home in high-NMR settings. Routine chlorhexidine application, preferably daily for 7 to 10 days after birth, should therefore be recommended in these infants. Given the paucity of evidence, there is presently no justification for recommending this intervention in infants born in health facilities and/or low-NMR settings.

Project description:BackgroundOmphalitis is an important contributor to neonatal mortality in Kenya. Chlorhexidine digluconate 7.1 % w/w (CHX; equivalent to 4 % w/w chlorhexidine) was identified as a life-saving commodity for newborn cord care by the United Nations and is included on World Health Organization and Kenyan Essential Medicines Lists. This pilot study assessed the potential resource savings and breakeven price of implementing CHX for neonatal umbilical cord care versus dry cord care (DCC) in Kenya.MethodsWe employed a cost-consequence model in a Kenyan birth cohort. Firstly, the number of omphalitis cases and cases avoided by healthcare sector were estimated. Incidence rates and treatment effect inputs were calculated from a Cochrane meta-analysis of randomised clinical trials (RCTs) (base case) and 2 other RCTs. Economic outcomes associated with omphalitis cases avoided were determined, including direct, indirect and total cost of care associated with omphalitis, resource use (outpatient visits and bed days) and societal impact (caregiver workdays lost). Costs and other inputs were sourced from literature and supplemented by expert clinical opinion/informed inputs, making necessary assumptions.ResultsThe model estimated that, over 1 year, ~ 23,000 omphalitis cases per 500,000 births could be avoided through CHX application versus DCC, circumventing ~ 13,000 outpatient visits, ~ 43,000 bed days and preserving ~ 114,000 workdays. CHX was associated with annual direct cost savings of ~ 590,000 US dollars (USD) versus DCC (not including drug-acquisition cost), increasing to ~ 2.5 million USD after including indirect costs (productivity, notional salary loss). The most-influential model parameter was relative risk of omphalitis with CHX versus DCC. Breakeven analysis identified a budget-neutral price for CHX use of 1.18 USD/course when accounting for direct cost savings only, and 5.43 USD/course when including indirect cost savings. The estimated breakeven price was robust to parameter input changes. DCC does not necessarily represent standard of care in Kenya; other, potentially harmful, approaches may be used, meaning cost savings may be understated.ConclusionsEstimated healthcare cost savings and potential health benefits provide compelling evidence to implement CHX for umbilical cord care in Kenya. We encourage comprehensive data collection to make future models and estimates of impacts of upscaling CHX use more robust.

Project description:AbstractThere are conflicting results from large randomized controlled trials in different populations regarding the effectiveness of topical application of 4% chlorhexidine to the umbilical stump of newborn infants at reducing neonatal mortality. Meta-analysis and systematic review of trials performed in South Asia and Europe support 4% chlorhexidine application to reduce neonatal mortality, whereas trials performed in Sub-Saharan Africa do not. The aim of this review is to determine the effectiveness of 4% chlorhexidine application to the umbilical stump of newborn infants born in lower income countries in order to reduce neonatal mortality when compared with usual cord care.Our search strategy included randomized trials published between January1st 2000 and September 4th, 2018, that compared 4% chlorhexidine with usual cord care ("dry cord care"). The outcome variable of interest was neonatal mortality. Pooled relative risks (RR) with 95% confidence intervals (CIs) using a random-effects model were calculated. Nine trials were included, from six countries: Zambia, Tanzania, Bangladesh, Nepal, India and Pakistan, with a total of 257,153 participants. Five studies (N = 119,833) reported neonatal mortality. There was a 21% reduction in neonatal mortality among with 4% chlorhexidine application: pooled RR (95% CI) 0.79 (0.69-0.90), P = 0.0005. The incidence of omphalitis was decreased by 35% with 4% chlorhexidine (6 studies, N = 108,263): pooled RR (95% CI) 0.65 (0.56-0.75), P = 0.00001. Chlorhexidine application delayed the umbilical cord separation time (4 studies, N = 28,917): mean difference (95% CI) 2.71 (2.63-2.78) days.In conclusion, this systematic review found that topical application of 4% chlorhexidine to the umbilical cord stump of newborn infants in lower income countries significantly reduces the incidence of neonatal mortality. Chlorhexidine also reduces the incidence of omphalitis, but prolongs umbilical cord separation time.Trial registrationSystematic Review Registration: CRD42018109280.

Project description:BackgroundThere is an increased risk of serious neonatal infection arising through exposure of the umbilical cord to invasive pathogen in home and facility births where hygienic practices are difficult to achieve. The World Health Organization currently recommends 'dry cord care' because of insufficient data in favor of or against topical application of an antiseptic. The primary objective of this meta-analysis is to evaluate the effects of application of chlorhexidine (CHX) to the umbilical cord to children born in low income countries on cord infection (omphalitis) and neonatal mortality. Standardized guidelines of Child Health Epidemiology Reference Group (CHERG) were followed to generate estimates of effectiveness of topical chlorhexidine application to umbilical cord for prevention of sepsis specific mortality, for inclusion in the Lives Saved Tool (LiST).MethodsSystematic review and meta-analysis. Data sources included Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, PubMed, CINHAL and WHO international clinical trials registry. Only randomized trials were included. Studies of children in hospital settings were excluded. The comparison group received no application to the umbilical cord (dry cord care), no intervention, or a non-CHX intervention. Primary outcomes were omphalitis and all-cause neonatal mortality.ResultsThere were three cluster-randomised community trials (total participants 54,624) conducted in Nepal, Bangladesh and Pakistan that assessed impact of CHX application to the newborn umbilical cord for prevention of cord infection and mortality. Application of any CHX to the umbilical cord of the newborn led to a 23% reduction in all-cause neonatal mortality in the intervention group compared to control [RR 0.77, 95 % CI 0.63, 0.94; random effects model, I2=50 %]. The reduction in omphalitis ranged from 27 % to 56 % compared to control group depending on severity of infection. Based on CHERG rules, effect size for all-cause mortality was used for inclusion to LiST model as a proxy for sepsis specific mortality.ConclusionsApplication of CHX to newborn umbilical cord can significantly reduce incidence of umbilical cord infection and all-cause mortality among home births in community settings. This inexpensive and simple intervention can save a significant number of newborn lives in developing countries.

Project description:BackgroundChlorhexidine (CHX) cleansing of the umbilical cord stump is an evidence-based intervention that reduces newborn infections and is recommended for high-mortality settings. Bangladesh is one of the first countries to adopt and scale up CHX nationally. This study evaluates the implementation outcomes for the CHX scale up in Bangladesh and identifies and describes key milestones and processes for the scale up.MethodsWe adapted the RE-AIM framework for this study, incorporating the WHO/ExpandNet model of Scale Up. Adoption and incorporation milestones were assessed through program documents and interviews with national stakeholders (n = 25). Provider training records served as a measure of reach. Implementation was assessed through a survey of readiness to provide CHX at public facilities (n = 4479) and routine data on the proportion of all live births at public facilities (n = 813 607) that received CHX from December 2016 to November 2017. Six rounds of a rolling household survey with recently-delivered women in four districts (n = 6000 to 8000 per round) measured the effectiveness and maintenance of the scale up in increasing population-level coverage of CHX in those districts.ResultsMore than 80 000 providers, supervisors, and managers across all 64 districts received a half-day training on CHX and essential newborn care between July 2015 and September 2016. Seventy-four percent of facilities had at least 70% of maternal and newborn health providers with CHX training, while only 46% had CHX in stock on the day of the assessment. The provision of CHX to newborns delivered at facilities steadily increased from 15 059 newborns (24%) in December 2016 to 71 704 (72%) in November 2017. In the final household survey of four districts, 33% of newborns were reported to receive CHX, and babies delivered at public facilities had 5.04 times greater odds (95% CI = 4.45, 5.72) of receiving CHX than those delivered at home.ConclusionsThe scale up of CHX in Bangladesh achieved sustained national implementation in public health facilities. Institutionalization barriers, such as changes to supply logistics systems, had to be addressed before expansion was achieved. For greater public health impact, implementation must reach deliveries that take place at home and in the private sector.

Project description:Hospital-based data from Africa suggest that newborn skin-cleansing with chlorhexidine may reduce neonatal mortality. Evaluation of this intervention in the communities where most births occur in the home has not been done. Our objective was to assess the efficacy of a 1-time skin-cleansing of newborn infants with 0.25% chlorhexidine on neonatal mortality.The design was a community-based, placebo-controlled, cluster-randomized trial in Sarlahi District in southern Nepal. Newborn infants were cleansed with infant wipes that contained 0.25% chlorhexidine or placebo solution as soon as possible after delivery in the home (median: 5.8 hours). The primary outcome was all-cause mortality by 28 days. After the completion of the randomized phase, all newborns in study clusters were converted to chlorhexidine treatment for the subsequent 9 months.A total of 17,530 live births occurred in the enrolled sectors, 8650 and 8880 in the chlorhexidine and placebo groups, respectively. Baseline characteristics were similar in the treatment groups. Intention-to-treat analysis among all live births showed no impact of the intervention on neonatal mortality. Among live-born infants who actually received their assigned treatment (98.7%), there was a nonsignificant 11% lower neonatal mortality rate among those who were treated with chlorhexidine compared with placebo. Low birth weight infants had a statistically significant 28% reduction in neonatal mortality; there was no significant difference among infants who were born weighing > or = 2500 g. After conversion to active treatment in the placebo clusters, there was a 37% reduction in mortality among low birth weight infants in the placebo clusters versus no change in the chlorhexidine clusters.Newborn skin-wiping with chlorhexidine solution once, soon after birth, reduced neonatal mortality only among low birth weight infants. Evidence from additional trials is needed to determine whether this inexpensive and simple intervention could improve survival significantly among low birth weight infants in settings where home delivery is common and hygiene practices are poor.

Project description:BackgroundUmbilical cord hygiene prevents sepsis, a leading cause of neonatal mortality. The World Health Organization recommends 7.1% chlorhexidine digluconate (CHX) application to the umbilicus after home birth in high mortality contexts. In Bangladesh and Nepal, national policies recommend CHX use for all facility births. Population-based household surveys include optional questions on CHX use, but indicator validation studies are lacking. The Every Newborn Birth Indicators Research Tracking in Hospitals (EN-BIRTH) was an observational study assessing measurement validity for maternal and newborn indicators. This paper reports results regarding CHX.MethodsThe EN-BIRTH study (July 2017-July 2018) included three public hospitals in Bangladesh and Nepal where CHX cord application is routine. Clinical-observers collected tablet-based, time-stamped data regarding cord care during admission to labour and delivery wards as the gold standard to assess accuracy of women's report at exit survey, and of routine-register data. We calculated validity ratios and individual-level validation metrics; analysed coverage, quality and measurement gaps. We conducted qualitative interviews to assess barriers and enablers to routine register-recording.ResultsUmbilical cord care was observed for 12,379 live births. Observer-assessed CHX coverage was very high at 89.3-99.4% in all 3 hospitals, although slightly lower after caesarean births in Azimpur (86.8%), Bangladesh. Exit survey-reported coverage (0.4-45.9%) underestimated the observed coverage with substantial "don't know" responses (55.5-79.4%). Survey-reported validity ratios were all poor (0.01 to 0.38). Register-recorded coverage in the specific column in Bangladesh was underestimated by 0.2% in Kushtia but overestimated by 9.0% in Azimpur. Register-recorded validity ratios were good (0.9 to 1.1) in Bangladesh, and poor (0.8) in Nepal. The non-specific register column in Pokhara, Nepal substantially underestimated coverage (20.7%).ConclusionsExit survey-report highly underestimated observed CHX coverage in all three hospitals. Routine register-recorded coverage was closer to observer-assessed coverage than survey reports in all hospitals, including for caesarean births, and was more accurately captured in hospitals with a specific register column. Inclusion of CHX cord care into registers, and tallied into health management information system platforms, is justified in countries with national policies for facility-based use, but requires implementation research to assess register design and data flow within health information systems.

Dataset Information

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.

Publications

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.

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