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

Background Chlorhexidine umbilical cord washes reduce neonatal mortality in south Asian populations with high neonatal mortality rates and predominantly home-based deliveries. No data exist for sub-Saharan African populations with lower neonatal mortality rates or mostly facility-based deliveries. We compared the eff ect of chlorhexidine with dry cord care on neonatal mortality rates in Zambia. Methods We undertook a cluster-randomised controlled trial in Southern Province, Zambia, with 90 health facilitybased clusters. We enrolled women who were in their second or third trimester of pregnancy, aged at least 15 years, and who would remain in the catchment area for follow-up of 28 days post-partum. Newborn babies received clean dry cord care (control) or topical application of 10 mL of a 4% chlorhexidine solution once per day until 3 days after cord drop (intervention), according to cluster assignment. We used stratifi ed, restricted randomisation to divide clusters into urban or two rural groups (located <40 km or ≥40 km to referral facility), and randomly assigned clusters (1:1) to use intervention (n=45) or control treatment (n=45). Sites, participants, and fi eld monitors were aware of their study assignment. The primary outcomes were all-cause neonatal mortality within 28 days post-partum and all-cause neonatal mortality within 28 days post-partum among babies who survived the fi rst 24 h of life. Analysis was by intention to treat. Neonatal mortality rate was compared with generalised estimating equations. This study is registered at ClinicalTrials.gov (NCT01241318). Findings From Feb 15, 2011, to Jan 30, 2013, we screened 42 356 pregnant women and enrolled 39 679 women (mean 436·2 per cluster [SD 65·3]), who had 37 856 livebirths and 723 stillbirths; 63·8% of deliveries were facility-based. Of livebirths, 18 450 (99·7%) newborn babies in the chlorhexidine group and 19 308 (99·8%) newborn babies in the dry cord care group were followed up to day 28 or death. 16 660 (90·0%) infants in the chlorhexidine group had chlorhexidine applied within 24 h of birth. We found no signifi cant diff erence in neonatal mortality rate between the chlorhexidine group (15·2 deaths per 1000 livebirths) and the dry cord care group (13·6 deaths per 1000 livebirths; risk ratio [RR] 1·12, 95% CI 0·88–1·44). Eliminating day 0 deaths yielded similar fi ndings (RR 1·12, 95% CI 0·86–1·47). Interpretation Despite substantial reductions previously reported in south Asia, chlorhexidine cord applications did not signifi cantly reduce neonatal mortality rates in Zambia. Chlorhexidine cord applications do not seem to provide clear benefi ts for newborn babies in settings with predominantly facility-based deliveries and lower (<30 deaths per 1000 livebirths) neonatal mortality rates

Components of clean delivery kits and newborn mortality in the Zambia Chlorhexidine Application Trial (ZamCAT): An observational study.

BackgroundNeonatal infection, a leading cause of neonatal death in low- and middle-income countries, is often caused by pathogens acquired during childbirth. Clean delivery kits (CDKs) have shown efficacy in reducing infection-related perinatal and neonatal mortality. However, there remain gaps in our current knowledge, including the effect of individual components, the timeline of protection, and the benefit of CDKs in home and facility deliveries.Methods and findingsA post hoc secondary analysis was performed using nonrandomized data from the Zambia Chlorhexidine Application Trial (ZamCAT), a community-based, cluster-randomized controlled trial of chlorhexidine umbilical cord care in Southern Province of Zambia from February 2011 to January 2013. CDKs, containing soap, gloves, cord clamps, plastic sheet, razor blade, matches, and candle, were provided to all pregnant women. Field monitors made a home-based visit to each participant 4 days postpartum, during which CDK use and newborn outcomes were ascertained. Logistic regression was used to study the association between different CDK components and neonatal mortality rate (NMR). Of 38,579 deliveries recorded during the study, 36,996 newborns were analyzed after excluding stillbirths and those with missing information. Gloves, cord clamps, and plastic sheets were the most frequently used CDK item combination in both home and facility deliveries. Each of the 7 CDK components was associated with lower NMR in users versus nonusers. Adjusted logistic regression showed that use of gloves (odds ratio [OR] 0.33, 95% CI 0.24-0.46), cord clamp (OR 0.51, 95% CI 0.38-0.68), plastic sheet (OR 0.46, 95% CI 0.34-0.63), and razor blade (OR 0.69, 95% CI 0.53-0.89) were associated with lower risk of newborn mortality. Use of gloves and cord clamp were associated with reduced risk of immediate newborn death (ConclusionsCDK use was associated with reductions in early newborn mortality at both home and facility deliveries, especially when certain kit components were used. While causality could not be established in this nonrandomized secondary analysis, given these beneficial associations, scaling up the use of CDKs in rural areas of sub-Saharan Africa may improve neonatal outcomes.Trial registrationName of trial: Zambia Chlorhexidine Application Trial (ZamCAT) Name of registry: Clinicaltrials.gov Trial number: NCT01241318

Finding a Needle in the Haystack: The Costs and Cost-Effectiveness of Syphilis Diagnosis and Treatment during Pregnancy to Prevent Congenital Syphilis in Kalomo District of Zambia

<div><p>Background</p><p>In March 2012, The Elizabeth Glaser Pediatric AIDS Foundation trained maternal and child health workers in Southern Province of Zambia to use a new rapid syphilis test (RST) during routine antenatal care. A recent study by Bonawitz et al. (2014) evaluated the impact of this roll out in Kalomo District. This paper estimates the costs and cost-effectiveness from the provider's perspective under the actual conditions observed during the first year of the RST roll out.</p><p>Methods</p><p>Information on materials used and costs were extracted from program records. A decision-analytic model was used to evaluate the costs (2012 USD) and cost-effectiveness. Basic parameters needed for the model were based on the results from the evaluation study.</p><p>Results</p><p>During the evaluation study, 62% of patients received a RST, and 2.8% of patients tested were positive (and 10.4% of these were treated). Even with very high RST sensitivity and specificity (98%), true prevalence of active syphilis would be substantially less (estimated at <0.7%). For 1,000 new ANC patients, costs of screening and treatment were estimated at $2,136, and the cost per avoided disability-adjusted-life year lost (DALY) was estimated at$628. Costs change little if all positives are treated (because prevalence is low and treatment costs are small), but the cost-per-DALY avoided falls to just $66. With full adherence to guidelines, costs increase to$3,174 per 1,000 patients and the cost-per-DALY avoided falls to $60.</p><p>Conclusions</p><p>Screening for syphilis is only useful for reducing adverse birth outcomes if patients testing positive are actually treated. Even with very low prevalence of syphilis (a needle in the haystack), cost effectiveness improves dramatically if those found positive are treated; additional treatment costs little but DALYs avoided are substantial. Without treatment, the needle is essentially found and thrown back into the haystack.</p></div

Global health training for pediatric residents

The FOPO Global Health Working Group concludes that global health experiences are important for pediatric residency training and offers five recommendations: 1) There is a need to articulate clearly the rationale supporting the creation of global health experiences in pediatric residency programs. 2) A core curriculum needs to be established for a consistent and meaningful educational experience. The curriculum should include the underlying principles discussed above and should engage representatives from potential host countries in the development of the curriculum. 3) Promoting the opportunity for a global health experience in all residency programs will require a collaborative effort across programs, perhaps at the national level through the Association of Pediatric Program Directors or through the already established Global Health Education Consortium (GHEC).34 A clearinghouse for curricula and for host organizations/institutions both abroad and within the United States and Canada should be established. 4) Global health training needs to be studied rigorously, and lessons learned should be shared. 5) Pediatric residency programs should respect the rights, autonomy, and confidentiality of patients and families in clinical care, research, and operational programs. The FOPO Global Health Working Group looks forward to serving as a focal point to promote discussion on this important issue to the health of our world\u27s children

Costs per 1,000 patients presenting for antenatal care and patient management as observed during evaluation study (Scenario ES).

<p>Costs per 1,000 patients presenting for antenatal care and patient management as observed during evaluation study (Scenario ES).</p

Material costs per RST and per RPR test (ZMW and US$ 2012).

<p>Material costs per RST and per RPR test (ZMW and US$ 2012).</p

Detailed assumptions used for base case costing and cost-effectiveness analysis (scenario ES^*).

<p>*The base case scenario, called Scenario ES, is the full set of information that is used to estimate costs per 1,000 new ANC patients and cost effectiveness. Information in Scenario is based on prevalence and patient management as observed during the evaluation study (a 12 month period following RST training and the roll out in Kalomo District) and information on costs as presented in <a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0113868#pone-0113868-t001" target="_blank">Tables 1</a>–<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0113868#pone-0113868-t003" target="_blank">3</a> and additional information as needed. Sources for all information are provided in the table.</p><p>**Nurse level MS08 on government salary scale, ZMW 32,451 annual salary and all benefits, 220 working days per year, 8 hours per day.</p><p>***With 2.8% testing positive during the evaluation study, we identified the combination of true prevalence, sensitivity, and specificity that are consistent with the 2.8% testing positive.</p><p>Detailed assumptions used for base case costing and cost-effectiveness analysis (scenario ES^{<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0113868#nt101" target="_blank">*</a>}).</p

Summary of results per 1,000 ANC patients for additional sensitivity analyses.

<p>*True prevalence  =  proportion with active or past treated syphilis; 80% true prevalence with active syphilis.</p><p>Summary of results per 1,000 ANC patients for additional sensitivity analyses.</p