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.

Using interprofessional education to build dynamic teams to help drive collaborative, coordinated and effective newborn care.

BACKGROUND: As countries strive to achieve sustainable development goal 3.2, high-quality medical education is crucial for high-quality neonatal care. Women are encouraged to deliver in health units attended by a skilled team. Traditionally, the team is doctors and nurses, but they are members of a large group of interdependent experts from other disciplines. Each discipline trains separately, yet the goal of good neonatal care is common to all. The use of interprofessional education breaks down these professional silos improving collaborative practice and promoting excellent clinical care. Introduction of new educational materials and training requires a rigorous approach to ensure sustainability. METHODS: An extensive needs assessment identified gaps in neonatal training. Specifically, there was a lack of inclusion of medical devices used in clinical care. In each country, national key stakeholders came together to develop and revise their own neonatal curricula, trainings or guidelines. A core writing education team were tasked to develop evidence-based materials on pertinent medical devices to include in these national materials. These then underwent internal and external review. A provider course for biomedical engineers and technicians was introduced. Skills labs were established to improve practical skills teaching. To improve the quality of teaching, a NEST360 generic instructors course (GIC) was developed. RESULTS: Twenty modules, 14 scenarios, 17 job aids and 34 videos have been published to date. Materials have been embedded into neonatal curricula and national trainings. Forty-one skills labs were installed in pre-service learning institutions and, up to June 2022, have been used by 7281 students. Pre- and in-service interprofessional training was implemented at all NEST360 institutions (clinical and biomedical). GIC courses were conducted at least twice a year in all countries. Three hundred seventeen nurses, biomedical and clinical staff have undertaken the GIC in all four countries. GIC participants report that the course has very positively influenced their teaching practice. CONCLUSIONS: Inclusion of key stakeholders throughout has ensured training is embedded within the four countries. Use of interprofessional education and inclusion of biomedical engineers and technicians has been very successful. Introduction of the GIC has developed a pool of high-quality educators for neonatal care. This approach has ensured that high-quality interprofessional neonatal training is included within national agendas for neonatal care and beyond.

Target product profiles for neonatal care devices: systematic development and outcomes with NEST360 and UNICEF.

BACKGROUND: Medical devices are critical to providing high-quality, hospital-based newborn care, yet many of these devices are unavailable in low- and middle-income countries (LMIC) and are not designed to be suitable for these settings. Target Product Profiles (TPPs) are often utilised at an early stage in the medical device development process to enable user-defined performance characteristics for a given setting. TPPs can also be applied to assess the profile and match of existing devices for a given context. METHODS: We developed initial TPPs for 15 newborn product categories for LMIC settings. A Delphi-like process was used to develop the TPPs. Respondents completed an online survey where they scored their level of agreement with each of the proposed performance characteristics for each of the 15 devices. Characteristics with < 75% agreement between respondents were discussed and voted on using Mentimeter™ at an in-person consensus meeting. FINDINGS: The TPP online survey was sent to 180 people, of which 103 responded (57%). The majority of respondents were implementers/clinicians (51%, 53/103), with 50% (52/103) from LMIC. Across the 15 TPPs, 403 (60%) of the 668 performance characteristics did not achieve > 75% agreement. Areas of disagreement were voted on by 69 participants at an in-person consensus meeting, with consensus achieved for 648 (97%) performance characteristics. Only 20 (3%) performance characteristics did not achieve consensus, most (15/20) relating to quality management systems. UNICEF published the 15 TPPs in April 2020, accompanied by a report detailing the online survey results and consensus meeting discussion, which has been viewed 7,039 times (as of January 2023). CONCLUSIONS: These 15 TPPs can inform developers and enable implementers to select neonatal care products for LMIC. Over 2,400 medical devices and diagnostics meeting these TPPs have been installed in 65 hospitals in Nigeria, Tanzania, Kenya, and Malawi through the NEST360 Alliance. Twenty-three medical devices identified and qualified by NEST360 meet nearly all performance characteristics across 11 of the 15 TPPs. Eight of the 23 qualified medical devices are available in the UNICEF Supply Catalogue. Some developers have adjusted their technologies to meet these TPPs. There is potential to adapt the TPP process beyond newborn care.

Devices and furniture for small and sick newborn care: systematic development of a planning and costing tool.

BACKGROUND: High-quality neonatal care requires sufficient functional medical devices, furniture, fixtures, and use by trained healthcare workers, however there is lack of publicly available tools for quantification and costing. This paper describes development and use of a planning and costing tool regarding furniture, fixtures and devices to support scale-up of WHO level-2 neonatal care, for national and global newborn survival targets. METHODS: We followed a systematic process. First, we reviewed planning and costing tools of relevance. Second, we co-designed a new tool to estimate furniture and device set-up costs for a default 40-bed level-2 neonatal unit, incorporating input from multi-disciplinary experts and newborn care guidelines. Furniture and device lists were based off WHO guidelines/norms, UNICEF and national manuals/guides. Due to lack of evidence-based quantification, ratios were based on operational manuals, multi-country facility assessment data, and expert opinion. Default unit costs were from government procurement agency costs in Kenya, Nigeria, and Tanzania. Third, we refined the tool by national use in Tanzania. RESULTS: The tool adapts activity-based costing (ABC) to estimate quantities and costs to equip a level-2 neonatal unit based on three components: (1) furniture/fixtures (18 default but editable items); (2) neonatal medical devices (16 product categories with minimum specifications for use in low-resource settings); (3) user training at device installation. The tool was used in Tanzania to generate procurement lists and cost estimates for level-2 scale-up in 171 hospitals (146 District and 25 Regional Referral). Total incremental cost of all new furniture and equipment acquisition, installation, and user training were US$93,000 per District hospital (level-2 care) and US$346,000 per Regional Referral hospital. Estimated cost per capita for whole-country district coverage was US$0.23, representing 0.57% increase in government health expenditure per capita and additional 0.35% for all Regional Referral hospitals. CONCLUSION: Given 2.3 million neonatal deaths and potential impact of level-2 newborn care, rational and efficient planning of devices linked to systems change is foundational. In future iterations, we aim to include consumables, spare parts, and maintenance cost options. More rigorous implementation research data are crucial to formulating evidence-based ratios for devices numbers per baby. Use of this tool could help overcome gaps in devices numbers, advance efficiency and quality of neonatal care.

A neonatal ward-strengthening program improves survival for neonates treated with CPAP at district hospitals in Malawi.

From 2013-2015, a CPAP quality improvement program (QIP) was implemented to introduce and monitor CPAP usage and outcomes in the neonatal wards at all government district and central hospitals in Malawi. In 2016 the CPAP QIP was extended into healthcare facilities operated by the Christian Health Association of Malawi. Although clinical outcomes improved, ward assessments indicated that many rural sites lacked other essential equipment and a suitable space to adequately treat sick neonates, which likely limited the impact of improved respiratory care. The aim of this study was to determine if a ward-strengthening program improved outcomes for neonates treated with CPAP. To address the needs identified from ward assessments, a ward-strengthening program was implemented from 2017-2018 at rural hospitals in Malawi to improve the care of sick neonates. The ward-strengthening program included the distribution of a bundle of equipment, supplemental training, and, in some cases, health facility renovations. Survival to discharge was compared for neonates treated with CPAP at 12 rural hospitals for one year before and for one year immediately after implementation of the ward-strengthening program. In the year prior to ward strengthening, 189 neonates were treated with CPAP; in the year after, 232 neonates received CPAP. The overall rate of survival for those treated with CPAP improved from 46.6% to 57.3% after ward strengthening (p = 0.03). For the subset of neonates with admission weights between 1.00-2.49 kg diagnosed with respiratory distress syndrome, survival increased from 39.4% to 60.3% after ward strengthening (p = 0.001). A ward-strengthening program including the distribution of a bundle of equipment, supplemental training, and some health facility renovations, further improved survival among neonates treated with CPAP at district-level hospitals in Malawi.

National scale of neonatal CPAP to district hospitals in Malawi improves survival for neonates weighing between 1.0 and 1.3 kg.

OBJECTIVE: 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.

Neonatal CPAP for Respiratory Distress Across Malawi and Mortality.

OBJECTIVES: 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.