Feasibility and usability of a very low-cost bubble continuous positive airway pressure device including oxygen blenders in a Ugandan level two newborn unit.

BACKGROUND: Preterm birth and resulting respiratory failure is a leading cause of newborn death- the majority of which occur in resource-constrained settings and could be prevented with bubble continuous positive airway pressure (bCPAP). Commercialized devices are expensive, however, and sites commonly use improvised devices utilizing 100% oxygen which can cause blindness. To address this, PATH and a multidisciplinary team developed a very low-cost bCPAP device including fixed-ratio oxygen blenders. OBJECTIVE: We assessed feasibility of use of the device on neonatal patients as well as the usability and acceptability of the device by healthcare workers. This study did not evaluate device effectiveness. METHODS: The study took place in a Ugandan level two unit. Neonates with respiratory failure were treated with the bCPAP device. Prospective data were collected through observation as well as likert-style scales and interviews with healthcare workers. Data were analyzed using frequencies, means and standard deviation and interviews via a descriptive coding method. Retrospectively registered via ClinicalTrials.gov number NCT05462509. RESULTS: Fourteen neonates were treated with the bCPAP device in October-December 2021. Patients were born onsite (57%), with median weight of 1.3 kg (IQR 1-1.8). Median treatment length was 2.5 days (IQR 2-6). bCPAP was stopped due to: improvement (83%) and death (17%). All patients experienced episodes of saturations >95%. Median time for device set up: 15 minutes (IQR 12-18) and changing the blender: 15 seconds (IQR 12-27). After initial device use, 9 out of 9 nurses report the set-up as well as blender use was "easy" and their overall satisfaction with the device was 8.5/10 (IQR 6.5-9.5). Interview themes included the appreciation for the ability to administer less than 100% oxygen, desire to continue use of the device, and a desire for additional blenders. CONCLUSIONS: In facilities otherwise using 100% oxygen, use of the bCPAP device including oxygen blenders is feasible and acceptable to healthcare workers. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier NCT05462509.

Impact of the early COVID-19 pandemic on outcomes in a rural Ugandan neonatal unit: A retrospective cohort study.

BACKGROUND: During the early COVID-19 pandemic travel in Uganda was tightly restricted which affected demand for and access to care for pregnant women and small and sick newborns. In this study we describe changes to neonatal outcomes in one rural central Ugandan newborn unit before and during the early phase of the COVID-19 pandemic. METHODS: We report outcomes from admissions captured in an electronic dataset of a well-established newborn unit before (September 2019 to March 2020) and during the early COVID-19 period (April-September 2020) as well as two seasonally matched periods one year prior. We report excess mortality as the percent change in mortality over what was expected based on seasonal trends. FINDINGS: The study included 2,494 patients, 567 of whom were admitted during the early COVID-19 period. During the pandemic admissions decreased by 14%. Patients born outside the facility were older on admission than previously (median 1 day of age vs. admission on the day of birth). There was an increase in admissions with birth asphyxia (22% vs. 15% of patients). Mortality was higher during COVID-19 than previously [16% vs. 11%, p = 0.017]. Patients born outside the facility had a relative increase of 55% above seasonal expected mortality (21% vs. 14%, p = 0.028). During this period patients had decreased antenatal care, restricted transport and difficulty with expenses and support. The hospital had difficulty with maternity staffing and supplies. There was significant community and staff fear of COVID-19. INTERPRETATION: Increased newborn mortality during the early COVID-19 pandemic at this facility was likely attributed to disruptions affecting maternal and newborn demand for, access to and quality of perinatal healthcare. Lockdown conditions and restrictions to public transit were significant barriers to maternal and newborn wellbeing, and require further focus by national and regional health officials.

Mixed-method study to assess the feasibility, acceptability and early effectiveness of the Hospital to Home programme for follow-up of high-risk newborns in a rural district of Central Uganda: a study protocol.

INTRODUCTION: A follow-up programme designed for high-risk newborns discharged from inpatient newborn units in low-resource settings is imperative to ensure these newborns receive the healthiest possible start to life. We aim to assess the feasibility, acceptability and early outcomes of a discharge and follow-up programme, called Hospital to Home (H2H), in a neonatal unit in central Uganda. METHODS AND ANALYSIS: We will use a mixed-methods study design comparing a historical cohort and an intervention cohort of newborns and their caregivers admitted to a neonatal unit in Uganda. The study design includes two main components. The first component includes qualitative interviews (n=60 or until reaching saturation) with caregivers, community health workers called Village Health Team (VHT) members and neonatal unit staff. The second component assesses and compares outcomes between a prospective intervention cohort (n=100, born between July 2019 and September 2019) and a historical cohort (n=100, born between July 2018 and September 2018) of infants. The historical cohort will receive standard care while the intervention cohort will receive standard care plus the H2H intervention. The H2H intervention comprises training for healthcare workers on lactation, breast feeding and neurodevelopmentally supportive care, including cue-based feeding, and training to caregivers on recognition of danger signs and care of their high-risk infants. Infants and their families receive home visits until 6 months of age, or longer if necessary, by specially trained VHTs. Quantitative data will be analysed using descriptive statistics and regression analysis. All results will be stratified by cohort group. Qualitative data will be analysed guided by Braun and Clarke's thematic analysis technique. ETHICS AND DISSEMINATION: This study protocol was approved by the relevant Ugandan ethics committees. All participants will provide written informed consent. We will disseminate through peer-reviewed publications and key stakeholders and public engagement. TRIAL REGISTRATION NUMBER: ISRCTN51636372; Pre-result.