Oxygen systems to improve clinical care and outcomes for children and neonates: A stepped-wedge cluster-randomised trial in Nigeria

Abstract

BackgroundImproving oxygen systems may improve clinical outcomes for hospitalised children with acute lower respiratory infection (ALRI). This paper reports the effects of an improved oxygen system on mortality and clinical practices in 12 general, paediatric, and maternity hospitals in southwest Nigeria.Methods and findingsWe conducted an unblinded stepped-wedge cluster-randomised trial comparing three study periods: baseline (usual care), pulse oximetry introduction, and stepped introduction of a multifaceted oxygen system. We collected data from clinical records of all admitted neonates (<28 days old) and children (28 days to 14 years old). Primary analysis compared the full oxygen system period to the pulse oximetry period and evaluated odds of death for children, children with ALRI, neonates, and preterm neonates using mixed-effects logistic regression. Secondary analyses included the baseline period (enabling evaluation of pulse oximetry introduction) and evaluated mortality and practice outcomes on additional subgroups. Three hospitals received the oxygen system intervention at 4-month intervals. Primary analysis included 7,716 neonates and 17,143 children admitted during the 2-year stepped crossover period (November 2015 to October 2017). Compared to the pulse oximetry period, the full oxygen system had no association with death for children (adjusted odds ratio [aOR] 1.06; 95% confidence interval [CI] 0.77–1.46; p = 0.721) or children with ALRI (aOR 1.09; 95% CI 0.50–2.41; p = 0.824) and was associated with an increased risk of death for neonates overall (aOR 1.45; 95% CI 1.04–2.00; p = 0.026) but not preterm/low-birth-weight neonates (aOR 1.30; 95% CI 0.76–2.23; p = 0.366). Secondary analyses suggested that the introduction of pulse oximetry improved oxygen practices prior to implementation of the full oxygen system and was associated with lower odds of death for children with ALRI (aOR 0.33; 95% CI 0.12–0.92; p = 0.035) but not for children, preterm neonates, or neonates overall (aOR 0.97, 95% CI 0.60–1.58, p = 0.913; aOR 1.12, 95% CI 0.56–2.26, p = 0.762; aOR 0.90, 95% CI 0.57–1.43, p = 0.651). Limitations of our study are a lower-than-anticipated power to detect change in mortality outcomes (low event rates, low participant numbers, high intracluster correlation) and major contextual changes related to the 2016–2017 Nigerian economic recession that influenced care-seeking and hospital function during the study period, potentially confounding mortality outcomes.ConclusionsWe observed no mortality benefit for children and a possible higher risk of neonatal death following the introduction of a multifaceted oxygen system compared to introducing pulse oximetry alone. Where some oxygen is available, pulse oximetry may improve oxygen usage and clinical outcomes for children with ALRI.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12617000341325.

Improving Hospital Oxygen Systems for COVID-19 in Low-Resource Settings: Lessons From the Field

“…Our work has shown how to combine quality equipment and training to achieve context-appropriate and sustainable improvement in oxygen systems and improve clinical outcomes. 5,[11][12][13] This experience has informed the development of clinical and technical guidance by the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) [14][15][16] and is now informing oxygen scale-up for COVID-19 (Box).…”

“…2 Pulse oximetry, with practical task-based training and simple guidelines, can enable health care workers to target oxygen toward those who need it most, dramatically improving patient oxygen access and clinical outcomes. 13 In contexts where pulse oximetry is not a standard of care, COVID-19 offers an opportunity to establish oxygen saturation as the "fifth vital sign." However, although pulse oximetry is a simple skill, it is a fundamentally new concept for many health care workers and will require encouragement and support to integrate it into the workflow.…”

“… 2 Pulse oximetry, with practical task-based training and simple guidelines, can enable health care workers to target oxygen toward those who need it most, dramatically improving patient oxygen access and clinical outcomes. 13 In contexts where pulse oximetry is not a standard of care, COVID-19 offers an opportunity to establish oxygen saturation as the “fifth vital sign.” However, although pulse oximetry is a simple skill, it is a fundamentally new concept for many health care workers and will require encouragement and support to integrate it into the workflow. 19 Education and support for health care workers to use pulse oximetry and oxygen therapy should also cover maintenance and functioning of oxygen equipment, recognizing the critical importance of health care worker and technician teamwork in maintaining a reliable oxygen supply.…”

Oxygen systems and quality of care for children with pneumonia, malaria and diarrhoea: Analysis of a stepped-wedge trial in Nigeria

“…Effective oxygen systems are an important element of quality hospital care and are critical for achieving good clinical outcomes for patients with severe pneumonia [1,2]. Improvements in hospital oxygen systems have been shown to reduce inpatient child mortality from pneumonia by 35-58%, yet oxygen access for patients remains poor in many low-and middle-income countries (LMICs) [3][4][5][6][7][8]. The COVID-19 pandemic has further highlighted the importance of improving hospital oxygen systems, and the fatal consequences of deficient systems, pushing oxygen access higher onto the global health agenda [9,10].…”

“…Results are published elsewhere [5,[16][17][18][19][20][21][22]. We found that the introduction of pulse oximetry and improved oxygen systems contributed to marked improvements in pulse oximetry and oxygen practices and was associated with reduced risk of death for children admitted with pneumonia, but not other illnesses [5]. Importantly, we observed the greatest impact on pneumonia mortality with the introduction of pulse oximetry (prior to implementing the full oxygen system) and received qualitative feedback that pulse oximetry may have had broader positive effects on other care practices [5,19].…”