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9 result(s) for "Zakane, Alphonse"
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Azithromycin for infants at risk of poor growth and development: A pooled secondary analysis of two randomized controlled trials
In 2023, the World Health Organization (WHO) revised its guidelines for management of severe acute malnutrition (SAM). The revised guidelines include a focus on infants at risk of poor growth and development. The guideline identifies evaluation of routine antibiotics for these infants as a priority research area. We pooled data from two large randomized controlled trials evaluating azithromycin for prevention of infant mortality in Burkina Faso to assess whether azithromycin reduces mortality or wasting in this subgroup. Infants in the two trials were 1-12 weeks of age at enrollment. Infants were considered at risk of poor risk of growth and development per WHO: underweight (weight-for-age Z-score, WAZ < -2), wasted (weight-for-length Z-score, WLZ < -2), or MUAC < 11.0 cm among infants ≥6 weeks of age. Infants were randomized to a single oral (20 mg/kg) dose of azithromycin or matching placebo and were followed until 6 months of age. We evaluated vital status, underweight (WAZ < -2), wasting (WLZ < -2), and stunting (length-for-age Z-score, LAZ) at 6 months among infants at risk of poor growth and development based on WHO single measurement criteria. A total of 54,709 infants were enrolled in the two trials. Of these, 9,728 were at risk of poor growth and development based on baseline WAZ (N = 5,385), WLZ (N = 6,022), or MUAC (N = 1,541). We found no evidence of a difference in mortality (1.3% vs 1.1%, odds ratio, OR, 1.19, 95% confidence interval, CI, 0.82 to 1.72) or wasting (20.6% vs 20.2%, OR 1.03, 95% CI 0.92 to 1.14) at 6 months among infants receiving azithromycin versus placebo. In infants aged 1-12 weeks at risk of poor growth and development, we do not have evidence that single dose azithromycin reduces mortality or improves growth outcomes. ClinicalTrials.gov NCT03682654 and NCT03676764.
Neonatal anthropometric indicators of infant growth and mortality in Burkina Faso
Most evidence supporting screening for undernutrition is for children aged 6-59 months. However, the highest risk of mortality and highest incidence of wasting occurs in the first 6 months of life. We evaluated relationships between neonatal anthropometric indicators, including birth weight, weight-for-age -score (WAZ), weight-for-length Z-score (WLZ), length-for-age -score (LAZ) and mid-upper arm circumference (MUAC) and mortality and growth at 6 months of age among infants in Burkina Faso. Data arose from a randomised controlled trial evaluating neonatal azithromycin administration for the prevention of child mortality. We evaluated relationships between baseline anthropometric measures and mortality, wasting (WLZ < -2), stunting (LAZ < -2) and underweight (WAZ < -2) at 6 months of age were estimated using logistic regression models adjusted for the child's age and sex. Five regions of Burkina Faso. Infants aged 8-27 d followed until 6 months of age. Of 21 832 infants enrolled in the trial, 7·9 % were low birth weight (<2500 g), 13·3 % were wasted, 7·7 % were stunted and 7·4 % were underweight at enrolment. All anthropometric deficits were associated with mortality by 6 months of age, with WAZ the strongest predictor (WAZ < -2 to ≥ -3 at enrolment . WAZ ≥ -2: adjusted OR, 3·91, 95 % CI, 2·21, 6·56). Low WAZ was also associated with wasting, stunting, and underweight at 6 months. Interventions for identifying infants at highest risk of mortality and growth failure should consider WAZ as part of their screening protocol.
Azithromycin as adjunctive treatment for uncomplicated severe acute malnutrition (AMOUR): study protocol for a double-masked randomised controlled trial
IntroductionAmoxicillin is recommended for children with uncomplicated severe acute malnutrition (SAM). However, some trials have shown no difference in amoxicillin for nutritional recovery in children with SAM compared with placebo. In addition, amoxicillin treatment requires two times per day dosing for 7 days, which may influence adherence. Azithromycin is a broad-spectrum antibiotic that can be provided as a single dose and has reduced mortality in children aged 1–59 months when provided by mass drug administration. The AMOUR trial is designed to assess amoxicillin, azithromycin and placebo as part of outpatient treatment of uncomplicated SAM.Methods and analysisThis double-masked randomised controlled trial will enrol 3000 children over 3 years in an individually randomised 1:1:1 allocation to azithromycin, amoxicillin or placebo arms and follow them for 12 months. Children eligible to enrol in the study will be aged 6–59 months and have uncomplicated non-oedematous SAM as defined by weight-for-height Z-score <−3 SD and/or mid-upper arm circumference <115 mm. Additionally, the children must not have received antibiotics in the past 7 days and have not received nutritional programme treatment for SAM in the 2 weeks before enrolling in the study. Each participant will receive a 7-day course of treatment or placebo based on the arm they were randomised to; 1 dose of azithromycin plus placebo for consistency in the number of doses, 7 days of amoxicillin or 7 days of placebo, with the first dose directly observed in all arms. The primary endpoint outcome will be weight gain defined by g/kg/day at 8 weeks. Mortality and relapse will be assessed at 8 weeks and 3 months, 6 months, 9 months and 12 months.Ethics and disseminationEthical approval was obtained from the Institutional Review Board at the University of California, San Francisco (Protocol 23–39411) and the Comité d’Ethique pour la Recherche en Santé in Ouagadougou, Burkina Faso (Protocol 2024-01-08). The results of this study will be disseminated to the Ministry of Health, community stakeholders and via peer-reviewed publications and academic conferences.Trial registration numberNCT06010719.
Analysis of knowledge, attitudes, and practices related to antibiotics and antimicrobial resistance awareness among community members in Ghana and Burkina Faso
Background Antimicrobial resistance (AMR) is a global health concern, particularly in low- and middle-income countries. As human behaviour plays a crucial role in the emergence and spread of resistance, data on the understanding of AMR awareness are very important for assessing the situation and developing effective interventions. The aim of this study was to analyse the knowledge, attitudes and practices (KAP) related to antibiotics and awareness towards antibiotic resistance among community members in two districts in Ghana, and Burkina Faso. Methods A cross-sectional survey was used to collect data on socio-demographic, economic factors, and KAP. In Burkina Faso a simple randomization was carried out, whereas in Ghana we performed a double-stage randomization. The data was collected using an electronic data capture between February and March 2023 in Ghana, and from July to November 2023 in Burkina Faso. Data analysis employed descriptive statistics, and logistic regressions. Results A total of 1,114 participants in Ghana and 1,011 in Burkina Faso were included. The majority knew the term “Antibiotic” (Ghana: n  = 687, 61.67%; Burkina Faso: n  = 767, 75.87%), but only a minority were aware of AMR (Ghana: n  = 381, 34.2%; Burkina Faso: n  = 270, 26.71%). In both countries, participants had a middle level of knowledge about antibiotics (Ghana: n  = 597; 53.59%, Burkina Faso: n  = 502, 49.65%), positive attitudes towards antibiotic utilization (Ghana: n  = 702, 63.02%; Burkina Faso: n  = 510, 50.45%), and most of them reported a responsible use of antibiotics (Ghana: n  = 875, 78.55%; Burkina Faso: n  = 713, 70.52%). Conclusions Despite familiarity with antibiotics, self-reported responsible use did not align with actual observed behaviours in both countries. Additionally, a significant lack of awareness about AMR highlights the need for a targeted educational intervention to enhance understanding of its risks and increase appropriate practices.
Antenatal care attendance and risk of low birthweight in Burkina Faso: a cross-sectional study
Background Low birthweight is a major contributor to infant mortality. We evaluated the association between antenatal care (ANC) attendance and low birthweight among newborns in 5 regions of Burkina Faso. Methods We utilized data from the baseline assessment of a randomized controlled trial evaluating azithromycin distribution during the neonatal period for prevention of infant mortality. Neonates were eligible for the trial if the weighed at least 2500 g at enrollment and were 8–27 days of age. Data on ANC attendance and birthweight was extracted from each child’s carnet de santé , a government-issued health card on which pregnancy and birth-related data are recorded. We used linear and logistic regression models adjusting for potentially confounding variables to evaluate the relationship between ANC attendance (as total number of visits and ≥ 4 antenatal care visits) and birthweight (continuously and categorized into < 2500 g versus ≥2500 g). Results Data from 21,223 births were included in the analysis. The median number of ANC visits was 4 (interquartile range 3 to 5) and 69% of mothers attended at least 4 visits. Mean birthweight was 2998 g (standard deviation 423) and 8.1% of infants were low birthweight (< 2500 g). Birthweight was 63 g (95% CI 46 to 81 g, P  < 0.001) higher in newborns born to mothers who had attended ≥4 ANC visits versus < 4 visits. The odds of low birthweight among infants born to mothers with ≥4 ANC visits was 0.71 (95% CI 0.63 to 0.79, P  < 0.001) times the odds of low birthweight among infants born to mothers who attended < 4 ANC visits. Conclusions We observed a statistically significant association between ANC attendance and birthweight, although absolute differences were small. Improving access to ANC for all women may help improve birth outcomes. Trial registration The parent trial is registered at clinicaltrials.gov: NCT03682653 ; first registered 24 September 2018.
A Two-Center Randomized Trial of an Additional Early Dose of Measles Vaccine: Effects on Mortality and Measles Antibody Levels
In addition to protecting against measles, measles vaccine (MV) may have beneficial nonspecific effects. We tested the effect of an additional early MV on mortality and measles antibody levels. Children aged 4-7 months at rural health and demographic surveillance sites in Burkina Faso and Guinea-Bissau were randomized 1:1 to an extra early standard dose of MV (Edmonston-Zagreb strain) or no extra MV 4 weeks after the third diphtheria-tetanus-pertussis-hepatitis B-Haemophilus influenzae type b vaccine. All children received routine MV at 9 months. We assessed mortality through home visits and compared mortality from enrollment to age 3 years using Cox proportional hazards models, censoring for subsequent nontrial MV. Subgroups of participants had blood sampled to assess measles antibody levels. Among 8309 children enrolled from 18 July 2012 to 3 December 2015, we registered 145 deaths (mortality rate: 16/1000 person-years). The mortality was lower than anticipated and did not differ by randomization group (hazard ratio, 1.05; 95% confidence interval, 0.75-1.46). At enrollment, 4% (16/447) of children in Burkina Faso and 21% (90/422) in Guinea-Bissau had protective measles antibody levels. By age 9 months, no measles-unvaccinated/-unexposed child had protective levels, while 92% (306/333) of early MV recipients had protective levels. At final follow-up, 98% (186/189) in the early MV group and 97% (196/202) in the control group had protective levels. Early MV did not reduce all-cause mortality. Most children were susceptible to measles infection at age 4-7 months and responded with high antibody levels to early MV. NCT01644721.
No effect of an additional early dose of measles vaccine on hospitalization or mortality in children: A randomized controlled trial
•There was no effect of an additional early measles vaccination on severe morbidity.•There was no indication of a differential effect between boys and girls.•A non-significant beneficial effect of MV was seen with no OPV after randomization. Non-specific effects (NSEs) of vaccines have increasingly gained attention in recent years. Recent studies suggest that live vaccines, such as measles vaccine (MV), have beneficial effects on health, while inactivated vaccines, such as the diphtheria-tetanus-pertussis (DTP) vaccine, may have harmful effects. If this is the case, it should improve child health to move MV closer to the last vaccination with DTP. The objective of this study was to investigate the NSEs of an additional early dose of MV on hospitalization or mortality. Children were randomized to receive either the standard MV at 9 months (control) or an additional early dose of MV 4 weeks after the third dose of DTP-containing Pentavalent vaccine and the standard MV at 9 months (intervention). In this analysis of a secondary outcome in the trial, we investigated the effect of the intervention on a composite endpoint of over-night hospitalization with or without recovery, or death without previous hospitalization, in children between 4.5 and 36 months of age in the Nouna HDSS in Burkina Faso. We used Cox proportional hazards regression with repeated events and time since study enrolment as underlying time-scale. Among 2258 children in the intervention and 2238 children in the control group we observed a total of 464 episodes of hospitalization or mortality. There was no difference between intervention and control group (HR = 1.00, 95% Confidence Interval (CI) 0.83–1.20). Results from the per-protocol and intention-to-treat analysis were similar. Although no significant, results suggest a possible beneficial effect of early MV in children that had not been exposed to an OPV campaign after enrolment (HR = 0.83, 95% CI 0.55–1.29). We did not detect any effect of early MV on subsequent hospitalization or mortality. However, possible effects of early MV could have been obscured by NSEs of the frequent OPV campaigns. Registration: The trial was registered at ClinicalTrials.gov, NCT01644721
“Quality of prenatal and maternal care: bridging the know-do gap” (QUALMAT study): an electronic clinical decision support system for rural Sub-Saharan Africa
Background Despite strong efforts to improve maternal care, its quality remains deficient in many countries of Sub-Saharan Africa as persistently high maternal mortality rates testify. The QUALMAT study seeks to improve the performance and motivation of rural health workers and ultimately quality of primary maternal health care services in three African countries Burkina Faso, Ghana, and Tanzania. One major intervention is the introduction of a computerized Clinical Decision Support System (CDSS) for rural primary health care centers to be used by health care workers of different educational levels. Methods A stand-alone, java-based software, able to run on any standard hardware, was developed based on assessment of the health care situation in the involved countries. The software scope was defined and the final software was programmed under consideration of test experiences. Knowledge for the decision support derived from the World Health Organization (WHO) guideline “Pregnancy, Childbirth, Postpartum and Newborn Care; A Guide for Essential Practice”. Results The QUALMAT CDSS provides computerized guidance and clinical decision support for antenatal care, and care during delivery and up to 24 hours post delivery. The decision support is based on WHO guidelines and designed using three principles: (1) Guidance through routine actions in maternal and perinatal care, (2) integration of clinical data to detect situations of concern by algorithms, and (3) electronic tracking of peri- and postnatal activities. In addition, the tool facilitates patient management and is a source of training material. The implementation of the software, which is embedded in a set of interventions comprising the QUALMAT study, is subject to various research projects assessing and quantifying the impact of the CDSS on quality of care, the motivation of health care staff (users) and its health economic aspects. The software will also be assessed for its usability and acceptance, as well as for its influence on workflows in the rural setting of primary health care in the three countries involved. Conclusion The development and implementation of a CDSS in rural primary health care centres presents challenges, which may be overcome with careful planning and involvement of future users at an early stage. A tailored software with stable functionality should offer perspectives to improve maternal care in resource-poor settings. Trial registration http://www.clinicaltrials.gov/NCT01409824 .
The Use of Computerised Clinical Decision Support System in Maternal and Neonatal Care in Rural Africa : Enthusiasm and Concerns
Background: Maternal and neonatal mortality rates remain high in sub-Saharan Africa. The shortage of skilled Healthcare Workers (HCWs) and poor access to guidelines are plausible reasons for the reported low quality in maternal and neonatal services in rural Africa. One strategy to support HCWs at point of care is to provide easy access to guidelines using computerised Clinical Decision Support Systems (CDSS). Still, data are lacking on how such systems are optimally designed and implemented to be useful for HCWs.Aims: The aims were to develop a CDSS to be used in rural Africa (I), to understand perceived needs and attitudes among HCWs to the use of a CDSS based on the WHO guidelines in maternal and neonatal care in Burkina Faso (II), and to explore the reasons why the HCWs failed to use the CDSS as expected (III).Methods: The CDSS was programmed in java software language to be able to run on any hardware (I). The CDSS was part of an intervention to improve quality of care in six rural healthcare facilities in Burkina Faso for 24 months. A total of 45 HCWs were interviewed to capture perceived needs and attitudes to the CDSS. Data were analysed with content analysis (II). To understand any reduced use of the CDSS a workshop was organised (group discussions and a plenary session) with 13 HCWs with data analysed thematically (III). Socio-demographic data were analysed descriptively (II-III).Results: The CDSS was designed with a user interface and an XML database for storing patient data (signs and symptoms) as well as an algorithm to provide advice on recommended care and actions based on WHO guideline information. The CDSS was developed with limited input from HCWs (I). The HCWs expressed willingness to use new technologies such as a CDSS and computers but reported a fear of extra workload as well as a fear that the CDSS should be complicated to use (II). After 12 months, the decreased use of the CDSS was partly explained by unreliable power supply and poor fit between the CDSS and the daily workflow. Still, the HCWs were enthusiastic to learn more by using the CDSS (III).Conclusions: The CDSS was successfully developed and tested in rural Burkina Faso. Despite this, its use was unexpectedly low. It was found that: 1. the design and the implementation of a CDSS have to be contextualised; 2. the usage of the CDSS and the software performance need to be continuously monitored and 3. the HCWs need to be actively consulted during all phases of design and testing of a CDSS to enhance its use.