Health facility assessment of small and sick newborn care in low- and middle-income countries: systematic tool development and operationalisation with NEST360 and UNICEF.

BACKGROUND: Each year an estimated 2.3 million newborns die in the first 28 days of life. Most of these deaths are preventable, and high-quality neonatal care is fundamental for surviving and thriving. Service readiness is used to assess the capacity of hospitals to provide care, but current health facility assessment (HFA) tools do not fully evaluate inpatient small and sick newborn care (SSNC). METHODS: Health systems ingredients for SSNC were identified from international guidelines, notably World Health Organization (WHO), and other standards for SSNC. Existing global and national service readiness tools were identified and mapped against this ingredients list. A novel HFA tool was co-designed according to a priori considerations determined by policymakers from four African governments, including that the HFA be completed in one day and assess readiness across the health system. The tool was reviewed by > 150 global experts, and refined and operationalised in 64 hospitals in Kenya, Malawi, Nigeria, and Tanzania between September 2019 and March 2021. RESULTS: Eight hundred and sixty-six key health systems ingredients for service readiness for inpatient SSNC were identified and mapped against four global and eight national tools measuring SSNC service readiness. Tools revealed major content gaps particularly for devices and consumables, care guidelines, and facility infrastructure, with a mean of 13.2% (n = 866, range 2.2-34.4%) of ingredients included. Two tools covered 32.7% and 34.4% (n = 866) of ingredients and were used as inputs for the new HFA tool, which included ten modules organised by adapted WHO health system building blocks, including: infrastructure, pharmacy and laboratory, medical devices and supplies, biomedical technician workshop, human resources, information systems, leadership and governance, family-centred care, and infection prevention and control. This HFA tool can be conducted at a hospital by seven assessors in one day and has been used in 64 hospitals in Kenya, Malawi, Nigeria, and Tanzania. CONCLUSION: This HFA tool is available open-access to adapt for use to comprehensively measure service readiness for level-2 SSNC, including respiratory support. The resulting facility-level data enable comparable tracking for Every Newborn Action Plan coverage target four within and between countries, identifying facility and national-level health systems gaps for action.

Investment case for small and sick newborn care in Tanzania: systematic analyses.

BACKGROUND: Small and sick newborn care (SSNC) is critical for national neonatal mortality reduction targets by 2030. Investment cases could inform implementation planning and enable coordinated resource mobilisation. We outline development of an investment case for Tanzania to estimate additional financing for scaling up SSNC to 80% of districts as part of health sector strategies to meet the country's targets. METHODS: We followed five steps: (1) reviewed national targets, policies and guidelines; (2) modelled potential health benefits by increased coverage of SSNC using the Lives Saved Tool; (3) estimated setup and running costs using the Neonatal Device Planning and Costing Tool, applying two scenarios: (A) all new neonatal units and devices with optimal staffing, and (B) half new and half modifying, upgrading, or adding resources to existing neonatal units; (4) calculated budget impact and return on investment (ROI) and (5) identified potential financing opportunities. RESULTS: Neonatal mortality rate was forecast to fall from 20 to 13 per 1000 live births with scale-up of SSNC, superseding the government 2025 target of 15, and close to the 2030 Sustainable Development Goal 3.2 target of <12. At 85% endline coverage, estimated cumulative lives saved were 36,600 by 2025 and 80,000 by 2030. Total incremental costs were estimated at US$166 million for scenario A (US$112 million set up and US$54 million for running costs) and US$90 million for scenario B (US$65 million setup and US$25 million for running costs). Setup costs were driven by infrastructure (83%) and running costs by human resources (60%). Cost per capita was US$0.93 and the ROI is estimated to be between US$8-12 for every dollar invested. CONCLUSIONS: ROI for SSNC is higher compared to other health investments, noting many deaths averted followed by full lifespan. This is conservative since disability averted is not included. Budget impact analysis estimated a required 2.3% increase in total government health expenditure per capita from US$40.62 in 2020, which is considered affordable, and the government has already allocated additional funding. Our proposed five-step SSNC investment case has potential for other countries wanting to accelerate progress.

Neonatal inpatient dataset for small and sick newborn care in low- and middle-income countries: systematic development and multi-country operationalisation with NEST360.

BACKGROUND: Every Newborn Action Plan (ENAP) coverage target 4 necessitates national scale-up of Level-2 Small and Sick Newborn Care (SSNC) (with Continuous Positive Airway Pressure (CPAP)) in 80% of districts by 2025. Routine neonatal inpatient data is important for improving quality of care, targeting equity gaps, and enabling data-driven decision-making at individual, district, and national-levels. Existing neonatal inpatient datasets vary in purpose, size, definitions, and collection processes. We describe the co-design and operationalisation of a core inpatient dataset for use to track outcomes and improve quality of care for small and sick newborns in high-mortality settings. METHODS: A three-step systematic framework was used to review, co-design, and operationalise this novel neonatal inpatient dataset in four countries (Malawi, Kenya, Tanzania, and Nigeria) implementing with the Newborn Essential Solutions and Technologies (NEST360) Alliance. Existing global and national datasets were identified, and variables were mapped according to categories. A priori considerations for variable inclusion were determined by clinicians and policymakers from the four African governments by facilitated group discussions. These included prioritising clinical care and newborn outcomes data, a parsimonious variable list, and electronic data entry. The tool was designed and refined by > 40 implementers and policymakers during a multi-stakeholder workshop and online interactions. RESULTS: Identified national and international datasets (n = 6) contained a median of 89 (IQR:61-154) variables, with many relating to research-specific initiatives. Maternal antenatal/intrapartum history was the largest variable category (21, 23.3%). The Neonatal Inpatient Dataset (NID) includes 60 core variables organised in six categories: (1) birth details/maternal history; (2) admission details/identifiers; (3) clinical complications/observations; (4) interventions/investigations; (5) discharge outcomes; and (6) diagnosis/cause-of-death. Categories were informed through the mapping process. The NID has been implemented at 69 neonatal units in four African countries and links to a facility-level quality improvement (QI) dashboard used in real-time by facility staff. CONCLUSION: The NEST360 NID is a novel, parsimonious tool for use in routine information systems to inform inpatient SSNC quality. Available on the NEST360/United Nations Children's Fund (UNICEF) Implementation Toolkit for SSNC, this adaptable tool enables facility and country-level comparisons to accelerate progress toward ENAP targets. Additional linked modules could include neonatal at-risk follow-up, retinopathy of prematurity, and Level-3 intensive care.

Low-Cost Instructional Apparatus to Improve Training for Cervical Cancer Screening and Prevention.

BACKGROUND: Cervical cancer remains one of the leading causes of cancer for women in medically underserved areas. This is in part due to a lack of trained clinicians to provide the necessary diagnosis and treatment of precancerous lesions to prevent cervical cancer. Increasing medical provider knowledge and skills is important for the early detection and prevention of cervical precancer and cancer in medically underserved areas of the United States and globally. METHOD: LUCIA is a low-cost, universal cervical cancer instructional apparatus that can be used to teach and practice a variety of essential skills for cervical cancer screening, diagnosis, and treatment, including: visual inspection with acetic acid, Pap and human papillomavirus DNA specimen collection, colposcopy, endocervical curettage, cervical biopsy, cryotherapy, and loop electrosurgical excision procedure. EXPERIENCE: LUCIA was used to provide hands-on training in six courses held in Texas (n=3), El Salvador (n=1), and Mozambique, Africa (n=2). Standardized provider evaluations were administered at three of these courses and resulted in mean scores of 4.12/5 for usefulness, 4.46/5 for skill improvement, and 4.43/5 for ease of skill evaluation. CONCLUSION: LUCIA provides dynamic, real-time feedback that allows trainees to learn and practice important skills related to cervical cancer prevention while simulating a patient exam.

Efficacy of a low-cost bubble CPAP system in treatment of respiratory distress in a neonatal ward in Malawi.

BACKGROUND: Respiratory 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. METHODS: 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. FINDINGS: 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. INTERPRETATION: 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.

Efficacy of a low-cost bubble CPAP system in treatment of respiratory distress in a neonatal ward in Malawi.

BACKGROUND: Respiratory 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. METHODS: 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. FINDINGS: 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. INTERPRETATION: 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.

Chromatography paper as a low-cost medium for accurate spectrophotometric assessment of blood hemoglobin concentration.

Anemia affects a quarter of the world's population, and a lack of appropriate diagnostic tools often prevents treatment in low-resource settings. Though the HemoCue 201+ is an appropriate device for diagnosing anemia in low-resource settings, the high cost of disposables ($0.99 per test in Malawi) limits its availability. We investigated using spectrophotometric measurement of blood spotted on chromatography paper as a low-cost (<$0.01 per test) alternative to HemoCue cuvettes. For this evaluation, donor blood was diluted with plasma to simulate anemia, a micropipette spotted blood on paper, and a bench-top spectrophotometer validated the approach before the development of a low-cost reader. We optimized impregnating paper with chemicals to lyse red blood cells, paper type, drying time, wavelengths measured, and sensitivity to variations in volume of blood, and we validated our approach using patient samples. Lysing the blood cells with sodium deoxycholate dried in Whatman Chr4 chromatography paper gave repeatable results, and the absorbance difference between 528 nm and 656 nm was stable over time in measurements taken up to 10 min after sample preparation. The method was insensitive to the amount of blood spotted on the paper over the range of 5 µL to 25 µL. We created a low-cost, handheld reader to measure the transmission of paper cuvettes at these optimal wavelengths. Training and validating our method with patient samples on both the spectrometer and the handheld reader showed that both devices are accurate to within 2 g dL(-1) of the HemoCue device for 98% and 95% of samples, respectively.

A high-value, low-cost bubble continuous positive airway pressure system for low-resource settings: technical assessment and initial case reports.

Acute 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--consumer-grade 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.

Prospective randomized controlled study comparing low-cost LED and conventional phototherapy for treatment of neonatal hyperbilirubinemia.

Our objective was to carry out a prospective, randomized, single-blind study to evaluate whether light emitting diode (LED) phototherapy using a low-cost set of lights is as effective as conventional phototherapy in treating hyperbilirubinemia in neonates. The study included 45 pre-term neonates requiring phototherapy as per American Academy of Pediatrics guidelines; participants were randomized to receive phototherapy using LED-based lights, conventional fluorescent blue lights or conventional halogen lights. There were no statistically significant differences in the average bilirubin levels at the onset, at the maximum and at the end of treatment, nor in the duration of phototherapy treatment and the rate of decrease in bilirubin levels in the neonates receiving conventional fluorescent blue light, conventional halogen light and LED phototherapy. (Differences were considered significant at p < 0.05). The average rate of decrease of bilirubin levels was 0.047 ± 0.037 mg dl(-1) h(-1), 0.055 ± 0.056 mg dl(-1) h(-1) and 0.057 ± 0.045 mg dl(-1) h(-1) in the groups receiving conventional fluorescent blue light, conventional halogen light and LED phototherapy, respectively. The average duration of phototherapy treatment in the three groups was 108.8 ± 85.9 h, 92.8 ± 38.1 h, 110.4 ± 42.6 h, respectively. In this pilot study, LED phototherapy using a simple, low-cost set of lights was as effective as conventional phototherapy in the treatment of neonatal hyperbilirubinemia. LED phototherapy lights that deliver 30-40 µW cm(-2 )nm(-1) can be assembled in small quantities for