Department of Pediatrics, University of Alberta, Edmonton, AB, Canada.
Department of Paediatrics and Child Health, Mulago Hospital and Makerere University, Kampala, Uganda; Global Health Uganda, Kampala, Uganda.
Lancet. 2024 Feb 24;403(10428):756-765. doi: 10.1016/S0140-6736(23)02502-3. Epub 2024 Feb 14.
Supplemental O is not always available at health facilities in low-income and middle-income countries (LMICs). Solar-powered O delivery can overcome gaps in O access, generating O independent of grid electricity. We hypothesized that installation of solar-powered O systems on the paediatrics ward of rural Ugandan hospitals would lead to a reduction in mortality among hypoxaemic children.
In this pragmatic, country-wide, stepped-wedge, cluster randomised controlled trial, solar-powered O systems (ie, photovoltaic cells, battery bank, and O concentrator) were sequentially installed at 20 rural health facilities in Uganda. Sites were selected for inclusion based on the following criteria: District Hospital or Health Centre IV with paediatric inpatient services; supplemental O on the paediatric ward was not available or was unreliable; and adequate space to install solar panels, a battery bank, and electrical wiring. Allocation concealment was achieved for sites up to 2 weeks before installation, but the study was not masked overall. Children younger than 5 years admitted to hospital with hypoxaemia and respiratory signs were included. The primary outcome was mortality within 48 h of detection of hypoxaemia. The statistical analysis used a linear mixed effects logistic regression model accounting for cluster as random effect and calendar time as fixed effect. The trial is registered at ClinicalTrials.gov, NCT03851783.
Between June 28, 2019, and Nov 30, 2021, 2409 children were enrolled across 20 hospitals and, after exclusions, 2405 children were analysed. 964 children were enrolled before site randomisation and 1441 children were enrolled after site randomisation (intention to treat). There were 104 deaths, 91 of which occurred within 48 h of detection of hypoxaemia. The 48 h mortality was 49 (5·1%) of 964 children before randomisation and 42 (2·9%) of 1440 (one individual did not have vital status documented at 48 h) after randomisation (adjusted odds ratio 0·50, 95% CI 0·27-0·91, p=0·023). Results were sensitive to alternative parameterisations of the secular trend. There was a relative risk reduction of 48·7% (95% CI 8·5-71·5), and a number needed to treat with solar-powered O of 45 (95% CI 28-230) to save one life. Use of O increased from 484 (50·2%) of 964 children before randomisation to 1424 (98·8%) of 1441 children after randomisation (p<0·0001). Adverse events were similar before and after randomisation and were not considered to be related to the intervention. The estimated cost-effectiveness was US$25 (6-505) per disability-adjusted life-year saved.
This stepped-wedge, cluster randomised controlled trial shows the mortality benefit of improving O access with solar-powered O. This study could serve as a model for scale-up of solar-powered O as one solution to O insecurity in LMICs.
Grand Challenges Canada and The Women and Children's Health Research Institute.
在低收入和中等收入国家（LMICs）的卫生机构中，补充氧气并不总是可用的。太阳能供氧可以克服供氧方面的差距，实现独立于电网电力的供氧。我们假设在乌干达农村医院的儿科病房安装太阳能供氧系统将降低低氧血症儿童的死亡率。
在这项务实的、全国范围内的、阶梯式、集群随机对照试验中，太阳能供氧系统（即光伏电池、电池组和氧气浓缩器）在乌干达的 20 个农村卫生机构中依次安装。根据以下标准选择纳入的地点：有儿科住院服务的区医院或卫生中心 IV 级；儿科病房没有或不可靠的补充氧气；以及有足够的空间安装太阳能电池板、电池组和电线。在安装前最多 2 周对地点进行了隐藏分配，但总体上没有进行掩饰。有低氧血症和呼吸症状的 5 岁以下儿童入院。主要结局是低氧血症发现后 48 小时内的死亡率。统计分析使用了线性混合效应逻辑回归模型，考虑了聚类作为随机效应和日历时间作为固定效应。该试验在 ClinicalTrials.gov 上注册，编号为 NCT03851783。
在 2019 年 6 月 28 日至 2021 年 11 月 30 日期间，在 20 家医院共纳入了 2409 名儿童，排除后对 2405 名儿童进行了分析。在随机分组前纳入了 964 名儿童，在随机分组后纳入了 1441 名儿童（意向治疗）。有 104 例死亡，其中 91 例发生在低氧血症发现后的 48 小时内。在随机分组前，48 小时死亡率为 964 名儿童中的 49（5.1%），随机分组后为 1440 名儿童中的 42（2.9%）（1 名个体在 48 小时时未记录生命体征）（调整后的优势比 0.50，95%CI 0.27-0.91，p=0.023）。结果对季节性趋势的替代参数化敏感。相对风险降低了 48.7%（95%CI 8.5-71.5），使用太阳能供氧每挽救一条生命需要治疗的人数为 45（95%CI 28-230）。在随机分组前，使用氧气的儿童从 964 名中的 484 名（50.2%）增加到随机分组后 1441 名中的 1424 名（98.8%）（p<0.0001）。随机分组前后不良事件相似，且不认为与干预有关。估计的成本效益为每挽救一个残疾调整生命年节省 25 美元（6-505）。
这项阶梯式、集群随机对照试验表明，改善供氧可降低死亡率。这项研究可以作为在 LMICs 中扩大太阳能供氧规模的一个模式，作为解决供氧不安全问题的一个解决方案。
加拿大大挑战和妇女与儿童健康研究所。
