Browsing by Author "Molyneux, Elizabeth"
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Item AutoSyP: A Low-Cost, Low-Power Syringe Pump for Use in Low-Resource Settings(The American Society of Tropical Medicine and Hygiene, 2016) Juarez, Alexa; Maynard, Kelley; Skerrett, Erica; Molyneux, Elizabeth; Richards-Kortum, Rebecca; Dube, Queen; Oden, Z. Maria; Bioengineering; Rice 360 Institute for Global HealthThis article describes the design and evaluation of AutoSyP, a low-cost, low-power syringe pump intended to deliver intravenous (IV) infusions in low-resource hospitals. A constant-force spring within the device provides mechanical energy to depress the syringe plunger. As a result, the device can run on rechargeable battery power for 66 hours, a critical feature for low-resource settings where the power grid may be unreliable. The device is designed to be used with 5- to 60-mL syringes and can deliver fluids at flow rates ranging from 3 to 60 mL/hour. The cost of goods to build one AutoSyP device is approximately $500. AutoSyP was tested in a laboratory setting and in a pilot clinical study. Laboratory accuracy was within 4% of the programmed flow rate. The device was used to deliver fluid to 10 healthy adult volunteers and 30 infants requiring IV fluid therapy at Queen Elizabeth Central Hospital in Blantyre, Malawi. The device delivered fluid with an average mean flow rate error of −2.3% ± 1.9% for flow rates ranging from 3 to 60 mL/hour. AutoSyP has the potential to improve the accuracy and safety of IV fluid delivery in low-resource settings.Item Bubble continuous positive airway pressure(2019-06-11) Richards-Kortum, Rebecca; Oden, Maria Z.; Brown, Jocelyn Kaye; Miros, Robert H.J.; Molyneux, Elizabeth; Rice University; United States Patent and Trademark OfficeA bubble continuous positive airway pressure system may include an adjustable flow generator configured to control a flow rate of air to be delivered to a patient. A pressure-regulated delivery system is configured to control a pressure delivered to the patient interface. The delivery system is operatively connected to a pressure control tube. One end of the pressure control tube is submerged in a liquid. A patient interface is configured to transfer pressure from the pressure control tube to the patient's airway.Item Cost-effectiveness analysis of a low-cost bubble CPAP device in providing ventilatory support for neonates in Malawi - a preliminary report(BioMed Central, 2014) Chen, Ariel; Deshmukh, Ashish A.; Richards-Kortum, Rebecca; Molyneux, Elizabeth; Kawaza, Kondwani; Cantor, Scott B.; Bioengineering; Rice 360 Institute for Global HealthA low-cost bubble continuous positive airway pressure (bCPAP) device has been shown to be an excellent clinical alternative to nasal oxygen for the care of neonates with respiratory difficulty. However, the delivery of bCPAP requires more resources than the current routine care using nasal oxygen. We performed an economic evaluation to determine the cost-effectiveness of a low-cost bCPAP device in providing ventilatory support for neonates in Malawi. We used patient-level clinical data from a previously published non-randomized controlled study. Economic data were based on the purchase price of supplies and equipment, adjusted for shelf life, as well as hospital cost data from the World Health Organization. Costs and benefits were discounted at 3%. The outcomes were measured in terms of cost, discounted life expectancy, cost/life year gained and net benefits of using bCPAP or nasal oxygen. The incremental cost-effectiveness ratio and incremental net benefits determined the value of one intervention compared to the other. Subgroup analysis on several parameters (birth weight categories, diagnosis of respiratory distress syndrome, and comorbidity of sepsis) was conducted to evaluate the effect of these parameters on the cost-effectiveness. Nasal oxygen therapy was less costly (US$29.29) than the low-cost bCPAP device ($57.78). Incremental effectiveness associated with bCPAP was 6.78 life years (LYs). In the base case analysis, the incremental cost-effectiveness ratio for bCPAP relative to nasal oxygen therapy was determined to be $4.20 (95% confidence interval, US$2.29–US$16.67) per LY gained. The results were highly sensitive for all tested subgroups, particularly for neonates with birth weight 1– < 1.5 kg, respiratory distress syndrome, or comorbidity of sepsis; these subgroups had a higher probability that bCPAP would be cost effective. The bCPAP is a highly cost-effective strategy in providing ventilatory support for neonates in Malawi.Item Development and validation of a simple algorithm for initiation of CPAP in neonates with respiratory distress in Malawi(BMJ Publishing Group Ltd & Royal College of Paediatrics and Child Health, 2015) Hundalani, Shilpa G.; Richards-Kortum, Rebecca; Oden, Maria; Kawaza, Kondwani; Gest, Alfred; Molyneux, Elizabeth; BioengineeringBackground:Low-cost bubble continuous positive airway pressure (bCPAP) systems have been shown to improve survival in neonates with respiratory distress, in developing countries including Malawi. District hospitals in Malawi implementing CPAP requested simple and reliable guidelines to enable healthcare workers with basic skills and minimal training to determine when treatment with CPAP is necessary. We developed and validated TRY (T: Tone is good, R: Respiratory Distress and Y=Yes) CPAP, a simple algorithm to identify neonates with respiratory distress who would benefit from CPAP. Objective:To validate the TRY CPAP algorithm for neonates with respiratory distress in a low-resource setting. Methods: We constructed an algorithm using a combination of vital signs, tone and birth weight to determine the need for CPAP in neonates with respiratory distress. Neonates admitted to the neonatal ward of Queen Elizabeth Central Hospital, in Blantyre, Malawi, were assessed in a prospective, cross-sectional study. Nurses and paediatricians-in-training assessed neonates to determine whether they required CPAP using the TRY CPAP algorithm. To establish the accuracy of the TRY CPAP algorithm in evaluating the need for CPAP, their assessment was compared with the decision of a neonatologist blinded to the TRY CPAP algorithm findings. Results: 325 neonates were evaluated over a 2-month period; 13% were deemed to require CPAP by the neonatologist. The inter-rater reliability with the algorithm was 0.90 for nurses and 0.97 for paediatricians-in-training using the neonatologist's assessment as the reference standard. Conclusions:The TRY CPAP algorithm has the potential to be a simple and reliable tool to assist nurses and clinicians in identifying neonates who require treatment with CPAP in low-resource settings.Item Efficacy of a Low-Cost Bubble CPAP System in Treatment of Respiratory Distress in a Neonatal Ward in Malawi(Public Library of Science, 2014) Kawaza, Kondwani; Machen, Heather E.; Brown, Jocelyn; Mwanza, Zondiwe; Iniguez, Suzanne; Al, Gest; Smith, E. O'Brian; Oden, Maria; Richards-Kortum, Rebecca R.; Molyneux, Elizabeth; BioengineeringRespiratory failure is a leading cause of neonatal mortality in the developing world. Bubble continuous positive airway pressure (bCPAP) is a safe, effective intervention for infants with respiratory distress and is widely used in developed countries. Because of its high cost, bCPAP is not widely utilized in low-resource settings. We evaluated the performance of a new bCPAP system to treat severe respiratory distress in a low resource setting, comparing it to nasal oxygen therapy, the current standard of care. We conducted a non-randomized convenience sample study to test the efficacy of a low-cost bCPAP system treating newborns with severe respiratory distress in the neonatal ward of Queen Elizabeth Central Hospital, in Blantyre,Malawi. Neonates weighing .1,000 g and presenting with severe respiratory distress who fulfilled inclusion criteria received nasal bCPAP if a device was available; if not, they received standard care. Clinical assessments were made during treatment and outcomes compared for the two groups. 87 neonates (62 bCPAP, 25 controls) were recruited. Survival rate for neonates receiving bCPAP was 71.0% (44/62)compared with 44.0% (11/25) for controls. 65.5% (19/29) of very low birth weight neonates receiving bCPAP survived to discharge compared to 15.4% (1/13) of controls. 64.6% (31/48) of neonates with respiratory distress syndrome (RDS)receiving bCPAP survived to discharge, compared to 23.5% (4/17) of controls. 61.5% (16/26) of neonates with sepsis receiving bCPAP survived to discharge, while none of the seven neonates with sepsis in the control group survived. Use of a low-cost bCPAP system to treat neonatal respiratory distress resulted in 27% absolute improvement in survival. The beneficial effect was greater for neonates with very low birth weight, RDS, or sepsis. Implementing appropriate bCPAP devices could reduce neonatal mortality in developing countries.Item A High-Value, Low-Cost Bubble Continuous Positive Airway Pressure System for Low-Resource Settings: Technical Assessment and Initial Case Reports(Public Library of Science, 2013) Brown, Jocelyn; Machen, Heather; Kawaza, Kondwani; Mwanza, Zondiwe; Iniguez, Suzanne; Lang, Hans; Gest, Alfred; Kennedy, Neil; Miros, Robert; Richards-Kortum, Rebecca; Molyneux, Elizabeth; Oden, Maria; BioengineeringAcute respiratory infections are the leading cause of global child mortality. In the developing world, nasal oxygen therapy is often the only treatment option for babies who are suffering from respiratory distress. Without the added pressure of bubble Continuous Positive Airway Pressure (bCPAP) which helps maintain alveoli open, babies struggle to breathe and can suffer serious complications, and frequently death. A stand-alone bCPAP device can cost $6,000, too expensive for most developing world hospitals. Here, we describe the design and technical evaluation of a new, rugged bCPAP system that can be made in small volume for a cost-of-goods of approximately $350. Moreover, because of its simple designﾗconsumergrade pumps, medical tubing, and regulators—it requires only the simple replacement of a ,$1 diaphragm approximately every 2 years for maintenance. The low-cost bCPAP device delivers pressure and flow equivalent to those of a reference bCPAP system used in the developed world. We describe the initial clinical cases of a child with bronchiolitis and a neonate with respiratory distress who were treated successfully with the new bCPAP device.Item Impact of hypothermia on implementation of CPAP for neonatal respiratory distress syndrome in a low-resource setting(Public Library of Science, 2018) Carns, Jennifer; Kawaza, Kondwani; Quinn, M.K.; Miao, Yinsen; Guerra, Rudy; Molyneux, Elizabeth; Oden, Maria; Richards-Kortum, Rebecca; Bioengineering; StatisticsBackground: Neonatal hypothermia is widely associated with increased risks of morbidity and mortality, but remains a pervasive global problem. No studies have examined the impact of hypothermia on outcomes for preterm infants treated with CPAP for respiratory distress syndrome (RDS). Methods: This retrospective analysis assessed the impact of hypothermia on outcomes of 65 neonates diagnosed with RDS and treated with either nasal oxygen (N = 17) or CPAP (N = 48) in a low-resource setting. A classification tree approach was used to develop a model predicting survival for subjects diagnosed with RDS. Findings: Survival to discharge was accurately predicted based on three variables: mean temperature, treatment modality, and mean respiratory rate. None of the 23 neonates with a mean temperature during treatment below 35.8°C survived to discharge, regardless of treatment modality. Among neonates with a mean temperature exceeding 35.8°C, the survival rate was 100% for the 31 neonates treated with CPAP and 36.4% for the 11 neonates treated with nasal oxygen (p<0.001). For neonates treated with CPAP, outcomes were poor if more than 50% of measured temperatures indicated hypothermia (5.6% survival). In contrast, all 30 neonates treated with CPAP and with more than 50% of temperature measurements above 35.8°C survived to discharge, regardless of initial temperature. Conclusion: The results of our study suggest that successful implementation of CPAP to treat RDS in low-resource settings will require aggressive action to prevent persistent hypothermia. However, our results show that even babies who are initially cold can do well on CPAP with proper management of hypothermia.Item A Lateral Flow Assay for Quantitative Detection of Amplified HIV-1 RNA(Public Library of Science, 2012) Rohrman, Brittany A.; Leautaud, Veronica; Molyneux, Elizabeth; Richards-Kortum, Rebecca R.; BioengineeringAlthough the accessibility of HIV treatment in developing nations has increased dramatically over the past decade, viral load testing to monitor the response of patients receiving therapy is often unavailable. Existing viral load technologies are often too expensive or resource-intensive for poor settings, and there is no appropriate HIV viral load test currently available at the point-of-care in low resource settings. Here, we present a lateral flow assay that employs gold nanoparticle probes and gold enhancement solution to detect amplified HIV RNA quantitatively. Preliminary results show that, when coupled with nucleic acid sequence based amplification (NASBA), this assay can detect concentrations of HIV RNA that match the clinically relevant range of viral loads found in HIV patients. The lateral flow test is inexpensive, simple and rapid to perform, and requires few resources. Our results suggest that the lateral flow assay may be integrated with amplification and sample preparation technologies to serve as an HIV viral load test for low-resource settings.Item National scale of neonatal CPAP to district hospitals in Malawi improves survival for neonates weighing between 1.0 and 1.3 kg(BMJ, 2022) Carns, Jennifer; Liaghati-Mobarhan, Sara; Asibon, Aba; Chalira, Alfred; Lufesi, Norman; Molyneux, Elizabeth; Oden, Maria Z.; Richards-Kortum, Rebecca; Kawaza, Kondwani; Bioengineering; Rice 360 Institute for Global HealthObjective To determine whether a national quality improvement programme implementing continuous positive airway pressure (CPAP) at government hospitals in Malawi improved outcomes for neonates prioritised by an algorithm recommending early CPAP for infants weighing 1.0–1.3 kg (the 50th percentile weight at 30 weeks’ gestation). Design The analysis includes neonates admitted with respiratory illness for 5.5 months before CPAP was introduced (baseline period) and for 15 months immediately after CPAP was implemented (implementation period). A follow-up data analysis was completed for neonates treated with CPAP for a further 11 months. Setting and patients Neonates with admission weights of 1.0–1.3 kg before (106 neonates treated with nasal oxygen) and after implementation of CPAP (153 neonates treated with nasal oxygen, 103 neonates treated with CPAP) in the newborn wards at Malawi government district hospitals. Follow-up analysis included 87 neonates treated with CPAP. Intervention Neonatal CPAP. Main outcome measure We assessed survival to discharge at 23 government district hospitals with no significant differences in transfer rates before and after implementation of CPAP. Results Survival improved for neonates with admission weights from 1.0 to 1.3 kg treated with CPAP (30.1%) as compared with neonates of the same weight band treated with oxygen during the baseline (17.9%) and implementation (18.3%) periods. There was no significant difference in survival for neonates treated with CPAP during the implementation and follow-up periods (30.1% vs 28.7%). Conclusions Survival for neonates weighing 1.0–1.3 kg significantly increased with a nurse-led CPAP service in a low-resource setting and improvements were sustained during follow-up.Item Neonatal CPAP for Respiratory Distress Across Malawi and Mortality(American Academy of Pediatrics, 2019) Carns, Jennifer; Kawaza, Kondwani; Liaghati-Mobarhan, Sara; Asibon, Aba; Quinn, Mary K.; Chalira, Alfred; Lufesi, Norman; Molyneux, Elizabeth; Oden, Maria; Richards-Kortum, Rebecca; BioengineeringOBJECTIVES: Our aim in this observational study was to monitor continuous positive airway pressure (CPAP) usage and outcomes in newborn wards at 26 government hospitals in Malawi after the introduction of CPAP as part of a quality-improvement initiative. CPAP was implemented in 3 phases from 2013 through 2015. METHODS: Survival to discharge was analyzed for neonates treated with nasal oxygen and/or CPAP with admission weights of 1 to 2.49 kg at 24 government hospitals with transfer rates <15%. This analysis includes neonates admitted with respiratory illness for 5.5 months before (621 neonates) and 15 months immediately after CPAP implementation (1836 neonates). A follow-up data analysis was completed for neonates treated with CPAP at all hospitals during an additional 11 months (194 neonates). RESULTS: On implementation of CPAP, survival to discharge improved for all neonates admitted with respiratory distress (48.6% vs 54.5%; P = .012) and for those diagnosed with respiratory distress syndrome (39.8% vs 48.3%; P = .042). There were no significant differences in outcomes for neonates treated with CPAP during the implementation and follow-up periods. Hypothermia on admission was pervasive and associated with poor outcomes. Neonates with normal mean temperatures during CPAP treatment experienced the highest survival rates (65.7% for all neonates treated with CPAP and 60.0% for those diagnosed with respiratory distress syndrome). CONCLUSIONS: A nurse-led CPAP service can improve outcomes for neonates in respiratory distress in low-resource settings. However, the results show that real-world improvements in survival may be limited without access to comprehensive newborn care, especially for small and sick infants.