Journal Article > ResearchFull Text
PLOS Med. 1 March 2016; Volume 13 (Issue 3); DOI:10.1371/journal.pmed.1001967
Sissoko D, Laouenan C, Folkesson E, M’Lebing A, Beavogui A, et al.
PLOS Med. 1 March 2016; Volume 13 (Issue 3); DOI:10.1371/journal.pmed.1001967
Ebola virus disease (EVD) is a highly lethal condition for which no specific treatment has proven efficacy. In September 2014, while the Ebola outbreak was at its peak, the World Health Organization released a short list of drugs suitable for EVD research. Favipiravir, an antiviral developed for the treatment of severe influenza, was one of these. In late 2014, the conditions for starting a randomized Ebola trial were not fulfilled for two reasons. One was the perception that, given the high number of patients presenting simultaneously and the very high mortality rate of the disease, it was ethically unacceptable to allocate patients from within the same family or village to receive or not receive an experimental drug, using a randomization process impossible to understand by very sick patients. The other was that, in the context of rumors and distrust of Ebola treatment centers, using a randomized design at the outset might lead even more patients to refuse to seek care. Therefore, we chose to conduct a multicenter non-randomized trial, in which all patients would receive favipiravir along with standardized care. The objectives of the trial were to test the feasibility and acceptability of an emergency trial in the context of a large Ebola outbreak, and to collect data on the safety and effectiveness of favipiravir in reducing mortality and viral load in patients with EVD. The trial was not aimed at directly informing future guidelines on Ebola treatment but at quickly gathering standardized preliminary data to optimize the design of future studies.
Journal Article > Short ReportFull Text
Euro Surveill. 22 January 2015; Volume 20 (Issue 3); DOI:10.2807/1560-7917.ES2015.20.3.21017
Moreau M, Spencer C, Gozalbes JG, Colebunders R, Lefevre A, et al.
Euro Surveill. 22 January 2015; Volume 20 (Issue 3); DOI:10.2807/1560-7917.ES2015.20.3.21017
Journal Article > ResearchFull Text
Public Health Action. 21 June 2017; Volume 7 (Issue 2); 168-174.; DOI:10.5588/pha.16.0127
Dornemann J, van den Boogaard W, Van der Bergh R, Takarinda KC, Martinez P, et al.
Public Health Action. 21 June 2017; Volume 7 (Issue 2); 168-174.; DOI:10.5588/pha.16.0127
SETTING
Although neonatal mortality is gradually decreasing worldwide, 98% of neonatal deaths occur in low- and middle-income countries, where hospital care for sick and premature neonates is often unavailable. Médecins Sans Frontières Operational Centre Brussels (MSF-OCB) managed eight specialised neonatal care units (SNCUs) at district level in low-resource and conflict-affected settings in seven countries.
OBJECTIVE
To assess the performance of the MSF SNCU model across different settings in Africa and Southern Asia, and to describe the set-up of eight SNCUs, neonate characteristics and clinical outcomes among neonates from 2012 to 2015. Design: Multicentric descriptive study.
RESULTS
The MSF SNCU model was characterised by an absence of high-tech equipment and an emphasis on dedicated nursing and medical care. Focus was on the management of hypothermia, hypoglycaemia, feeding support and early identification/treatment of infection. Overall, 11 970 neonates were admitted, 41% of whom had low birthweight (<2500 g). The main diagnoses were low birthweight, asphyxia and neonatal infections. Overall mortality was 17%, with consistency across the sites. Chances of survival increased with higher birthweight.
CONCLUSION
The standardised SNCU model was implemented across different contexts and showed in-patient outcomes within acceptable limits. Low-tech medical care for sick and premature neonates can and should be implemented at district hospital level in low-resource settings.
Although neonatal mortality is gradually decreasing worldwide, 98% of neonatal deaths occur in low- and middle-income countries, where hospital care for sick and premature neonates is often unavailable. Médecins Sans Frontières Operational Centre Brussels (MSF-OCB) managed eight specialised neonatal care units (SNCUs) at district level in low-resource and conflict-affected settings in seven countries.
OBJECTIVE
To assess the performance of the MSF SNCU model across different settings in Africa and Southern Asia, and to describe the set-up of eight SNCUs, neonate characteristics and clinical outcomes among neonates from 2012 to 2015. Design: Multicentric descriptive study.
RESULTS
The MSF SNCU model was characterised by an absence of high-tech equipment and an emphasis on dedicated nursing and medical care. Focus was on the management of hypothermia, hypoglycaemia, feeding support and early identification/treatment of infection. Overall, 11 970 neonates were admitted, 41% of whom had low birthweight (<2500 g). The main diagnoses were low birthweight, asphyxia and neonatal infections. Overall mortality was 17%, with consistency across the sites. Chances of survival increased with higher birthweight.
CONCLUSION
The standardised SNCU model was implemented across different contexts and showed in-patient outcomes within acceptable limits. Low-tech medical care for sick and premature neonates can and should be implemented at district hospital level in low-resource settings.
Journal Article > ResearchFull Text
Trop Med Int Health. 31 January 2017; Volume 22 (Issue 4); 423-430.; DOI:10.1111/tmi.12845
van den Boogaard W, Zuniga I, Manzi M, Van der Bergh R, Lefevre A, et al.
Trop Med Int Health. 31 January 2017; Volume 22 (Issue 4); 423-430.; DOI:10.1111/tmi.12845
OBJECTIVES
As neonatal care is being scaled up in economically poor settings, there is a need to know more on post-hospital discharge and longer-term outcomes. Of particular interest are mortality, prevalence of developmental impairments and malnutrition, all known to be worse in low-birthweight neonates (LBW, <2500 g). Getting a better handle on these parameters might justify and guide support interventions. Two years after hospital discharge, we thus assessed: mortality, developmental impairments and nutritional status of LBW children.
METHODS
Methods: Household survey of LBW neonates discharged from a neonatal special care unit in Rural Burundi between January and December 2012.
RESULTS
Of 146 LBW neonates, 23% could not be traced and 4% had died. Of the remaining 107 children (median age = 27 months), at least one developmental impairment was found in 27%, with 8% having at least five impairments. Main impairments included delays in motor development (17%) and in learning and speech (12%). Compared to LBW children (n = 100), very-low-birthweight (VLBW, <1500 g, n = 7) children had a significantly higher risk of impairments (intellectual - P = 0.001), needing constant supervision and creating a household burden (P = 0.009). Of all children (n-107), 18% were acutely malnourished, with a 3½ times higher risk in VLBWs (P = 0.02).
CONCLUSIONS
Reassuringly, most children were thriving 2 years after discharge. However, malnutrition was prevalent and one in three manifested developmental impairments (particularly VLBWs) echoing the need for support programmes. A considerable proportion of children could not be traced, and this emphasises the need for follow-up systems post-discharge.
As neonatal care is being scaled up in economically poor settings, there is a need to know more on post-hospital discharge and longer-term outcomes. Of particular interest are mortality, prevalence of developmental impairments and malnutrition, all known to be worse in low-birthweight neonates (LBW, <2500 g). Getting a better handle on these parameters might justify and guide support interventions. Two years after hospital discharge, we thus assessed: mortality, developmental impairments and nutritional status of LBW children.
METHODS
Methods: Household survey of LBW neonates discharged from a neonatal special care unit in Rural Burundi between January and December 2012.
RESULTS
Of 146 LBW neonates, 23% could not be traced and 4% had died. Of the remaining 107 children (median age = 27 months), at least one developmental impairment was found in 27%, with 8% having at least five impairments. Main impairments included delays in motor development (17%) and in learning and speech (12%). Compared to LBW children (n = 100), very-low-birthweight (VLBW, <1500 g, n = 7) children had a significantly higher risk of impairments (intellectual - P = 0.001), needing constant supervision and creating a household burden (P = 0.009). Of all children (n-107), 18% were acutely malnourished, with a 3½ times higher risk in VLBWs (P = 0.02).
CONCLUSIONS
Reassuringly, most children were thriving 2 years after discharge. However, malnutrition was prevalent and one in three manifested developmental impairments (particularly VLBWs) echoing the need for support programmes. A considerable proportion of children could not be traced, and this emphasises the need for follow-up systems post-discharge.
Journal Article > CommentaryFull Text
PLoS Negl Trop Dis. 22 June 2017; Volume 11 (Issue 6); e0005545.; DOI:10.1371/journal.pntd.0005545
Carazo Perez S, Folkesson E, Anglaret X, Beavogui A, Berbain E, et al.
PLoS Negl Trop Dis. 22 June 2017; Volume 11 (Issue 6); e0005545.; DOI:10.1371/journal.pntd.0005545
During the large Ebola outbreak that affected West Africa in 2014 and 2015, studies were launched to evaluate potential treatments for the disease. A clinical trial to evaluate the effectiveness of the antiviral drug favipiravir was conducted in Guinea. This paper describes the main challenges of the implementation of the trial in the Ebola treatment center of Guéckédou. Following the principles of the Good Clinical Research Practices, we explored the aspects of the community's communication and engagement, ethical conduct, trial protocol compliance, informed consent of participants, ongoing benefit/risk assessment, record keeping, confidentiality of patients and study data, and roles and responsibilities of the actors involved. We concluded that several challenges have to be addressed to successfully implement a clinical trial during an international medical emergency but that the potential for collaboration between research teams and humanitarian organizations needs to be highlighted.