Divisions of Neonatology and
Pediatric Pulmonology, University of Massachusetts Memorial Medical Center, Worcester, Massachusetts.
Pediatrics. 2020 Aug;146(2). doi: 10.1542/peds.2020-0079. Epub 2020 Jul 14.
To determine if a home oxygen therapy (HOT) management strategy that includes analysis of recorded home oximetry (RHO) data, compared with standard monthly clinic visit assessments, reduces duration of HOT without harm in premature infants.
The RHO trial was an unmasked randomized clinical trial conducted in 9 US medical centers from November 2013 to December 2017, with follow-up to February 2019. Preterm infants with birth gestation ≤37 + 0/7 weeks, discharged on HOT, and attending their first pulmonary visit were enrolled. The intervention was an analysis of transmitted RHO between clinic visits ( = 97); the standard-care group received monthly clinic visits with in-clinic weaning attempts ( = 99). The primary outcomes were the duration of HOT and parent-reported quality of life. There were 2 prespecified secondary safety outcomes: change in weight and adverse events within 6 months of HOT discontinuation.
Among 196 randomly assigned infants (mean birth gestational age: 26.9 weeks; SD: 2.6 weeks; 37.8% female), 166 (84.7%) completed the trial. In the RHO group, the mean time to discontinue HOT was 78.1 days (SE: 6.4), compared with 100.1 days (SE: 8.0) in the standard-care group ( = .03). The quality-of-life scores improved from baseline to 3 months after discontinuation of HOT in both groups ( = .002), but the degree of improvement did not differ significantly between groups ( = .75).
RHO was effective in reducing the duration of HOT in premature infants. Parent quality of life improved after discontinuation. RHO allows physicians to determine which infants can be weaned and which need prolonged oxygen therapy between monthly visits.
确定一种家庭氧疗(HOT)管理策略,包括对记录的家庭血氧饱和度(RHO)数据进行分析,与标准的每月诊所就诊评估相比,是否可以减少早产儿接受 HOT 的时间而不会造成伤害。
RHO 试验是一项于 2013 年 11 月至 2017 年 12 月在美国 9 家医疗中心进行的、无盲随机临床试验,随访至 2019 年 2 月。纳入在 HOT 出院并接受首次肺科就诊的出生胎龄≤37+0/7 周的早产儿。干预措施为在诊所就诊期间分析传输的 RHO(n=97);标准护理组接受每月的诊所就诊,并在诊所尝试脱机(n=99)。主要结局是 HOT 的持续时间和家长报告的生活质量。有 2 个预先指定的次要安全性结局:停止 HOT 后 6 个月内体重变化和不良事件。
在 196 名随机分配的婴儿中(平均胎龄:26.9 周;标准差:2.6 周;37.8%为女性),166 名(84.7%)完成了试验。在 RHO 组中,停止 HOT 的平均时间为 78.1 天(SE:6.4),而标准护理组为 100.1 天(SE:8.0)(=0.03)。两组在停止 HOT 后 3 个月的生活质量评分均从基线升高(=0.002),但两组间的改善程度无显著差异(=0.75)。
RHO 可有效缩短早产儿接受 HOT 的时间。停止 HOT 后,家长的生活质量提高。RHO 使医生能够确定哪些婴儿可以在每月就诊之间脱机,哪些需要延长吸氧治疗。