Pettersson M, Eriksson M, Albinsson E, Ohlin A
Department of Pediatrics, Faculty of Medicine and Health, Örebro University, S-701 85, Örebro, Sweden.
Faculty of Medicine and Health, School of Medical Sciences, Örebro University, Örebro, Sweden.
Eur J Pediatr. 2021 May;180(5):1603-1610. doi: 10.1007/s00431-021-03932-4. Epub 2021 Jan 19.
The aim of this study was to assess whether home phototherapy was feasible and safe in a cohort of otherwise healthy term-born neonates who fulfilled the criteria for in-hospital phototherapy. This was a randomized controlled trial in which term newborns with a total serum bilirubin of 18-24 mg/dL (300-400 μmol) were randomized to either home phototherapy or conventional in-hospital phototherapy. The primary outcome measurements were safety and efficacy, length of stay and the number of failed treatments. The secondary outcomes were the number of blood samples and weight gain during treatment. One hundred forty-seven patients were recruited, 69 patients randomized to conventional phototherapy and 78 to home phototherapy. The results showed that no patients needed blood exchange and only 4% of the patients allocated to home phototherapy were admitted to the hospital. The duration of phototherapy, length of stay, amount of blood tests and weight change showed no statically significant differences.Conclusion: Home phototherapy could be a safe alternative to inpatient phototherapy for otherwise healthy newborns with hyperbilirubinemia if daily checkups and 24/7 telephone support can be provided. The parents should be informed to contact the hospital immediately if they fail to perform the treatment at home.Trial registration: Clinicaltrials.gov NCT03536078 What is Known: • Phototherapy in the hospital is a safe and effective treatment without major side effects. • Fibre optic equipment has made the choice of home phototherapy possible. What is New: • This is the first randomized controlled trial comparing home phototherapy with hospital phototherapy. • Results indicate that home phototherapy could be considered as a safe and feasible alternative when performed according to instructions given, to hospital treatment for otherwise healthy term newborns.
本研究的目的是评估家庭光疗对于符合住院光疗标准的足月健康新生儿队列是否可行且安全。这是一项随机对照试验,将总血清胆红素为18 - 24mg/dL(300 - 400μmol)的足月新生儿随机分为家庭光疗组或传统住院光疗组。主要结局指标为安全性和有效性、住院时间及治疗失败次数。次要结局为治疗期间的血样采集次数和体重增加情况。共招募了147名患者,69名患者被随机分配至传统光疗组,78名患者被分配至家庭光疗组。结果显示,没有患者需要进行换血治疗,分配至家庭光疗组的患者中只有4%入院治疗。光疗持续时间、住院时间、血检量和体重变化均无统计学显著差异。结论:对于患有高胆红素血症的足月健康新生儿,如果能提供每日检查和全天候电话支持,家庭光疗可能是住院光疗的安全替代方案。应告知家长,如果他们在家中未能进行治疗,应立即联系医院。试验注册:Clinicaltrials.gov NCT03536078 已知信息:• 医院光疗是一种安全有效的治疗方法,无重大副作用。• 光纤设备使家庭光疗成为可能。新发现:• 这是第一项比较家庭光疗与医院光疗的随机对照试验。• 结果表明,对于足月健康新生儿,按照给定的说明进行家庭光疗可被视为医院治疗的一种安全可行的替代方案。