Potential effectiveness of integrating human milk banking and lactation support on neonatal outcomes at Pumwani Maternity Hospital, Kenya.

We assessed the potential effectiveness of human milk banking and lactation support on provision of human milk to neonates admitted in the newborn unit (NBU) at Pumwani Maternity Hospital, Kenya. This pre-post intervention study collected data from mothers/caregivers and their vulnerable neonates or term babies who lacked sufficient mother's milk for several reasons admitted in the NBU. The intervention included establishing a human milk bank and strengthening lactation support. Preintervention data were collected between 5 October 2018 and 11 November 2018, whereas postintervention data were collected between 4 September 2019 and 6 October 2019. Propensity score-matched analysis was performed to assess the effect of the intervention on exclusive use of human milk, use of human milk as the first feed, feeding intolerance and duration of NBU stay. The surveys included 123 and 116 newborns at preintervention and postintervention, respectively, with 160 newborns (80 in each group) being included in propensity score matched analysis. The proportion of neonates who exclusively used human milk during NBU stay increased from 41.3% preintervention to 63.8% postintervention (adjusted odds ratio [OR]: 2.68; 95% confidence interval [CI]: 1.31, 5.53) and those whose first feed was human milk increased from 55.0% preintervention to 83.3% postintervention (adjusted OR: 5.09; 95% CI: 2.18, 11.88). The mean duration of NBU stay was 27% (95% CI: 5.8%, 44.0%) lower in the postintervention group than in the preintervention group. The intervention did not affect feeding intolerance. Integrating human milk banking and lactation support may improve exclusive use of human milk among vulnerable neonates in a resource limited setting.

Pulse oximetry values of neonates admitted for care and receiving routine oxygen therapy at a resource-limited hospital in Kenya.

AIM: There are 2.7 million neonatal deaths annually, 75% of which occur in sub-Saharan Africa and South Asia. Effective treatment of hypoxaemia through tailored oxygen therapy could reduce neonatal mortality and prevent oxygen toxicity. METHODS: We undertook a two-part prospective study of neonates admitted to a neonatal unit in Nairobi, Kenya, between January and December 2015. We determined the prevalence of hypoxaemia and explored associations of clinical risk factors and signs of respiratory distress with hypoxaemia and mortality. After staff training on oxygen saturation (SpO2 ) target ranges, we enrolled a consecutive sample of neonates admitted for oxygen and measured SpO2 at 0, 6, 12, 18 and 24 h post-admission. We estimated the proportion of neonates outside the target range (≥34 weeks: ≥92%; <34 weeks: 89-93%) with 95% confidence intervals (CIs). RESULTS: A total of 477 neonates were enrolled. Prevalence of hypoxaemia was 29.2%. Retractions (odds ratio (OR) 2.83, 95% CI 1.47-5.47), nasal flaring (OR 2.68, 95% CI 1.51-4.75), and grunting (OR 2.47, 95% CI 1.27-4.80) were significantly associated with hypoxaemia. Nasal flaring (OR 2.85, 95% CI 1.25-6.54), and hypoxaemia (OR 3.06, 95% CI 1.54-6.07) were significantly associated with mortality; 64% of neonates receiving oxygen were out of range at ≥2 time points and 43% at ≥3 time points. CONCLUSION: There is a high prevalence of hypoxaemia at admission and a strong association between hypoxaemia and mortality in this Kenyan neonatal unit. Many neonates had out of range SpO2 values while receiving oxygen. Further research is needed to test strategies aimed at improving the accuracy of oxygen provision in low-resource settings.

Prevalence and correlates of treatment failure among Kenyan children hospitalised with severe community-acquired pneumonia: a prospective study of the clinical effectiveness of WHO pneumonia case management guidelines.

OBJECTIVE: To determine the extent and pattern of treatment failure (TF) among children hospitalised with community-acquired pneumonia at a large tertiary hospital in Kenya. METHODS: We followed up children aged 2-59 months with WHO-defined severe pneumonia (SP) and very severe pneumonia (VSP) for up to 5 days for TF using two definitions: (i) documentation of pre-defined clinical signs resulting in change of treatment (ii) primary clinician's decision to change treatment with or without documentation of the same pre-defined clinical signs. RESULTS: We enrolled 385 children. The risk of TF varied between 1.8% (95% CI 0.4-5.1) and 12.4% (95% CI 7.9-18.4) for SP and 21.4% (95% CI 15.9-27) and 39.3% (95% CI 32.5-46.4) for VSP depending on the definition applied. Higher rates were associated with early changes in therapy by clinician in the absence of an obvious clinical rationale. Non-adherence to treatment guidelines was observed for 70/169 (41.4%) and 67/201 (33.3%) of children with SP and VSP, respectively. Among children with SP, adherence to treatment guidelines was associated with the presence of wheeze on initial assessment (P = 0.02), while clinician non-adherence to guideline-recommended treatments for VSP tended to occur in children with altered consciousness (P < 0.001). Using propensity score matching to account for imbalance in the distribution of baseline clinical characteristics among children with VSP revealed no difference in TF between those treated with the guideline-recommended regimen vs. more costly broad-spectrum alternatives [risk difference 0.37 (95% CI -0.84 to 0.51)]. CONCLUSION: Before revising current pneumonia case management guidelines, standardised definitions of TF and appropriate studies of treatment effectiveness of alternative regimens are required.

Developing and testing a clinical care bundle incorporating caffeine citrate to manage apnoea of prematurity in a resource-constrained setting: a mixed methods clinical feasibility study protocol.

BACKGROUND: Apnoea of prematurity (AOP) is a common condition among preterm infants. Methylxanthines, such as caffeine and aminophylline/theophylline, can help prevent and treat AOP. Due to its physiological benefits and fewer side effects, caffeine citrate is recommended for the prevention and treatment of AOP. However, caffeine citrate is not available in most resource-constrained settings (RCS) due to its high cost. Challenges in RCS using caffeine citrate to prevent AOP include identifying eligible preterm infants where gestational age is not always known and the capability for continuous monitoring of vital signs to readily identify apnoea. We aim to develop an evidence-based care bundle that includes caffeine citrate to prevent and manage AOP in tertiary healthcare facilities in Kenya. METHODS: This protocol details a prospective mixed-methods clinical feasibility study on using caffeine citrate to manage apnoea of prematurity in a single facility tertiary-care newborn unit (NBU) in Nairobi, Kenya. This study will include a 4-month formative research phase followed by the development of an AOP clinical-care-bundle prototype over 2 months. In the subsequent 4 months, implementation and improvement of the clinical-care-bundle prototype will be undertaken. The baseline data will provide contextualised insights on care practices within the NBU that will inform the development of a context-sensitive AOP clinical-care-bundle prototype. The clinical care bundle will be tested and refined further during an implementation phase of the quality improvement initiative using a PDSA framework underpinned by quantitative and qualitative clinical audits and stakeholders' engagement. The quantitative component will include all neonates born at gestation age < 34 weeks and any neonate prescribed aminophylline or caffeine citrate admitted to the NBU during the study period. DISCUSSION: There is a need to develop evidence-based and context-sensitive clinical practice guidelines to standardise and improve the management of AOP in RCS. Concerns requiring resolution in implementing such guidelines include diagnosis of apnoea, optimal timing, dosing and administration of caffeine citrate, standardisation of monitoring devices and alarm limits, and discharge protocols. We aim to provide a feasible standardised clinical care bundle for managing AOP in low and middle-income settings.

A survey of barriers and facilitators to caffeine use for apnoea of prematurity in low- and middle-income countries.

BACKGROUND: Despite its associated benefits which include better long-term pulmonary and neurodevelopmental outcome, the use of caffeine for apnoea of prematurity (AoP) has been limited in low- and middle-income countries (LMIC). AIM: To better understand current caffeine use, the barriers and facilitators to its use and perceptions and practices in LMIC which have a disproportionately high burden of prematurity. METHODS: An anonymous online global survey was conducted, targeting healthcare providers working and training in paediatrics and/or neonatology in LMIC. RESULTS: A total of 181 respondents in 16 LMIC were included in the analysis; most were physicians working in publicly-funded urban tertiary hospitals. Most had received training in the use of caffeine for AoP (77%), reported expertise (70%) and confidence (96%) in its use, and had access to caffeine (65%). Caffeine availability was reported to be the greatest barrier (48%) and the greatest facilitator (37%). Other common barriers included cost (31%), access (7%) and policies or guidelines on caffeine use (7%); other common facilitators included policies or guidelines on caffeine use (11%), access (10%), staff/other providers' acceptance of caffeine as an appropriate treatment (9%) and the availability of staff to administer caffeine (8%). Most (79%) noted that access to caffeine was important, 92% agreed that caffeine improves quality of care, and 95% agreed that caffeine improves patient outcome. CONCLUSION: Improving availability and access to low-cost caffeine will be key to increasing caffeine use in LMIC. ABBREVIATIONS: AoP: Apnoea of Prematurity; LMIC: low- and middle-Income countries; REDCap: Research Electronic Data Capture.

Qualitative study exploring the feasibility, usability and acceptability of neonatal continuous monitoring technologies at a public tertiary hospital in Nairobi, Kenya.

OBJECTIVE: To assess the feasibility, usability and acceptability of two non-invasive, multiparameter, continuous physiological monitoring (MCPM) technologies for use in neonates within a resource-constrained healthcare setting in sub-Saharan Africa. DESIGN: A qualitative study using in-depth interviews and direct observations to describe healthcare professional and caregiver perspectives and experiences with investigational MCPM technologies from EarlySense and Sibel compared with selected reference technologies. SETTING: Pumwani Maternity Hospital is a public, high-volume, tertiary hospital in Nairobi, Kenya. PARTICIPANTS: In-depth interviews were conducted with five healthcare administrators, 12 healthcare providers and 10 caregivers. Direct observations were made of healthcare providers using the technologies on 12 neonates overall. RESULTS: Design factors like non-invasiveness, portability, ease-of-use and ability to measure multiple vital signs concurrently emerged as key themes supporting the usability and acceptability of the investigational technologies. However, respondents also reported feasibility challenges to implementation, including overcrowding in the neonatal unit, lack of reliable access to electricity and computers, and concerns about cost and maintenance needs. To improve acceptability, respondents highlighted the need for adequate staffing to appropriately engage caregivers and dispel misconceptions about the technologies. CONCLUSION: Study participants were positive about the usefulness of the investigational technologies to strengthen clinical care quality and identification of at-risk neonates for better access to timely interventions. These technologies have the potential to improve equity of access to appropriate healthcare services and neonatal outcomes in sub-Saharan African healthcare facilities. However, health system strengthening is also critical to support sustainable uptake of technologies into routine care. TRIAL REGISTRATION NUMBER: NCT03920761.

Clinical feasibility of an advanced neonatal epidermal multiparameter continuous monitoring technology in a large public maternity hospital in Nairobi, Kenya.

Clinically feasible multiparameter continuous physiological monitoring technologies are needed for use in resource-constrained African healthcare facilities to allow for early detection of critical events and timely intervention for major morbidities in high-risk neonates. We conducted a prospective clinical feasibility study of a novel multiparameter continuous physiological monitoring technology in neonates at Pumwani Maternity Hospital in Nairobi, Kenya. To assess feasibility, we compared the performance of Sibel's Advanced Neonatal Epidermal (ANNE) technology to reference technologies, including Masimo's Rad-97 pulse CO-oximeter with capnography technology for heart rate (HR), respiratory rate (RR), and oxygen saturation (SpO2) measurements and Spengler's Tempo Easy non-contact infrared thermometer for temperature measurements. We evaluated key performance criteria such as up-time, clinical event detection performance, and the agreement of measurements compared to those from the reference technologies in an uncontrolled, real-world setting. Between September 15 and December 15, 2020, we collected and analyzed 503 h of ANNE data from 109 enrolled neonates. ANNE's up-time was 42 (11%) h more for HR, 77 (25%) h more for RR, and 6 (2%) h less for SpO2 compared to the Rad-97. However, ANNE's ratio of up-time to total attached time was less than Rad-97's for HR (0.79 vs 0.86), RR (0.68 vs. 0.79), and SpO2 (0.69 vs 0.86). ANNE demonstrated adequate performance in identifying high and low HR and RR and high temperature events; however, showed relatively poor performance for low SpO2 events. The normalized spread of limits of agreement were 8.4% for HR and 52.2% for RR and the normalized root-mean-square deviation was 4.4% for SpO2. Temperature agreement showed a spread of limits of agreement of 2.8 °C. The a priori-identified optimal limits were met for HR and temperature but not for RR or SpO2. ANNE was clinically feasible for HR and temperature but not RR and SpO2 as demonstrated by the technology's up-time, clinical event detection performance, and the agreement of measurements compared to those from the reference technologies.

Clinical feasibility of a contactless multiparameter continuous monitoring technology for neonates in a large public maternity hospital in Nairobi, Kenya.

Multiparameter continuous physiological monitoring (MCPM) technologies are critical in the clinical management of high-risk neonates; yet, these technologies are frequently unavailable in many African healthcare facilities. We conducted a prospective clinical feasibility study of EarlySense's novel under-mattress MCPM technology in neonates at Pumwani Maternity Hospital in Nairobi, Kenya. To assess feasibility, we compared the performance of EarlySense's technology to Masimo's Rad-97 pulse CO-oximeter with capnography technology for heart rate (HR) and respiratory rate (RR) measurements using up-time, clinical event detection performance, and accuracy. Between September 15 and December 15, 2020, we collected and analyzed 470 hours of EarlySense data from 109 enrolled neonates. EarlySense's technology's up-time per neonate was 2.9 (range 0.8, 5.3) hours for HR and 2.1 (range 0.9, 4.0) hours for RR. The difference compared to the reference was a median of 0.6 (range 0.1, 3.1) hours for HR and 0.8 (range 0.1, 2.9) hours for RR. EarlySense's technology identified high HR and RR events with high sensitivity (HR 81%; RR 83%) and specificity (HR 99%; RR 83%), but was less sensitive for low HR and RR (HR 0%; RR 14%) although maintained specificity (HR 100%; RR 95%). There was a greater number of false negative and false positive RR events than false negative and false positive HR events. The normalized spread of limits of agreement was 9.6% for HR and 28.6% for RR, which met the a priori-identified limit of 30%. EarlySense's MCPM technology was clinically feasible as demonstrated by high percentage of up-time, strong clinical event detection performance, and agreement of HR and RR measurements compared to the reference technology. Studies in critically ill neonates, assessing barriers and facilitators to adoption, and costing analyses will be key to the technology's development and potential uptake and scale-up.

Neonatal mortality in Kenyan hospitals: a multisite, retrospective, cohort study.

BACKGROUND: Most of the deaths among neonates in low-income and middle-income countries (LMICs) can be prevented through universal access to basic high-quality health services including essential facility-based inpatient care. However, poor routine data undermines data-informed efforts to monitor and promote improvements in the quality of newborn care across hospitals. METHODS: Continuously collected routine patients' data from structured paper record forms for all admissions to newborn units (NBUs) from 16 purposively selected Kenyan public hospitals that are part of a clinical information network were analysed together with data from all paediatric admissions ages 0-13 years from 14 of these hospitals. Data are used to show the proportion of all admissions and deaths in the neonatal age group and examine morbidity and mortality patterns, stratified by birth weight, and their variation across hospitals. FINDINGS: During the 354 hospital months study period, 90 222 patients were admitted to the 14 hospitals contributing NBU and general paediatric ward data. 46% of all the admissions were neonates (aged 0-28 days), but they accounted for 66% of the deaths in the age group 0-13 years. 41 657 inborn neonates were admitted in the NBUs across the 16 hospitals during the study period. 4266/41 657 died giving a crude mortality rate of 10.2% (95% CI 9.97% to 10.55%), with 60% of these deaths occurring on the first-day of admission. Intrapartum-related complications was the single most common diagnosis among the neonates with birth weight of 2000 g or more who died. A threefold variation in mortality across hospitals was observed for birth weight categories 1000-1499 g and 1500-1999 g. INTERPRETATION: The high proportion of neonatal deaths in hospitals may reflect changing patterns of childhood mortality. Majority of newborns died of preventable causes (>95%). Despite availability of high-impact low-cost interventions, hospitals have high and very variable mortality proportions after stratification by birth weight.

Prediction modelling of inpatient neonatal mortality in high-mortality settings.

OBJECTIVE: Prognostic models aid clinical decision making and evaluation of hospital performance. Existing neonatal prognostic models typically use physiological measures that are often not available, such as pulse oximetry values, in routine practice in low-resource settings. We aimed to develop and validate two novel models to predict all cause in-hospital mortality following neonatal unit admission in a low-resource, high-mortality setting. STUDY DESIGN AND SETTING: We used basic, routine clinical data recorded by duty clinicians at the time of admission to derive (n=5427) and validate (n=1627) two novel models to predict in-hospital mortality. The Neonatal Essential Treatment Score (NETS) included treatments prescribed at the time of admission while the Score for Essential Neonatal Symptoms and Signs (SENSS) used basic clinical signs. Logistic regression was used, and performance was evaluated using discrimination and calibration. RESULTS: At derivation, c-statistic (discrimination) for NETS was 0.92 (95% CI 0.90 to 0.93) and that for SENSS was 0.91 (95% CI 0.89 to 0.93). At external (temporal) validation, NETS had a c-statistic of 0.89 (95% CI 0.86 to 0.92) and SENSS 0.89 (95% CI 0.84 to 0.93). The calibration intercept for NETS was -0.72 (95% CI -0.96 to -0.49) and that for SENSS was -0.33 (95% CI -0.56 to -0.11). CONCLUSION: Using routine neonatal data in a low-resource setting, we found that it is possible to predict in-hospital mortality using either treatments or signs and symptoms. Further validation of these models may support their use in treatment decisions and for case-mix adjustment to help understand performance variation across hospitals.

Evaluation of non-invasive continuous physiological monitoring devices for neonates in Nairobi, Kenya: a research protocol.

INTRODUCTION: Continuous physiological monitoring devices are often not available for monitoring high-risk neonates in low-resource settings. Easy-to-use, non-invasive, multiparameter, continuous physiological monitoring devices could be instrumental in providing appropriate care and improving outcomes for high-risk neonates in these low-resource settings. METHODS AND ANALYSIS: The purpose of this prospective, observational, facility-based evaluation is to provide evidence to establish whether two existing non-invasive, multiparameter, continuous physiological monitoring devices developed by device developers, EarlySense and Sibel, can accurately and reliably measure vital signs in neonates (when compared with verified reference devices). We will also assess the feasibility, usability and acceptability of these devices for use in neonates in low-resource settings in Africa. Up to 500 neonates are enrolled in two phases: (1) a verification and accuracy evaluation phase at Aga Khan University-Nairobi and (2) a clinical feasibility evaluation phase at Pumwani Maternity Hospital in Nairobi, Kenya. Both quantitative and qualitative data are collected and analysed. Agreement between the investigational and reference devices is determined using a priori-defined accuracy thresholds. ETHICS AND DISSEMINATION: This trial was approved by the Aga Khan University Nairobi Research Ethics Committee and the Western Institutional Review Board. We plan to disseminate research results in peer-reviewed journals and international conferences. TRIAL REGISTRATION NUMBER: NCT03920761.

Oxygen saturation ranges for healthy newborns within 24†hours at 1800†m.

There are minimal data to define normal oxygen saturation (SpO2) levels for infants within the first 24 hours of life and even fewer data generalisable to the 7% of the global population that resides at an altitude of >1500 m. The aim of this study was to establish the reference range for SpO2 in healthy term and preterm neonates within 24 hours in Nairobi, Kenya, located at 1800 m. A random sample of clinically well infants had SpO2 measured once in the first 24 hours. A total of 555 infants were enrolled. The 5th-95th percentile range for preductal and postductal SpO2 was 89%-97% for the term and normal birthweight groups, and 90%-98% for the preterm and low birthweight (LBW) groups. This may suggest that 89% and 97% are reasonable SpO2 bounds for well term, preterm and LBW infants within 24 hours at an altitude of 1800 m.