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Comparison of efficacy, safety & satisfaction of intermittent versus continuous phototherapy in hyperbilirubinaemic newborns ≥35 week gestation: A randomized controlled trial
Indian Journal of Medical Research ( IF 4.2 ) Pub Date : 2021-04-01 , DOI: 10.4103/ijmr.ijmr_2156_18 Sasi Bhushan Gottimukkala 1 , Giridhar Sethuraman 1 , Srinivasan Kitchanan 1 , Surajit Pathak 2
Indian Journal of Medical Research ( IF 4.2 ) Pub Date : 2021-04-01 , DOI: 10.4103/ijmr.ijmr_2156_18 Sasi Bhushan Gottimukkala 1 , Giridhar Sethuraman 1 , Srinivasan Kitchanan 1 , Surajit Pathak 2
Affiliation
Background & objectives: Phototherapy (PT) has become the standard of care for treating neonatal jaundice. This study was aimed to find out if intermittent PT (IPT) results in comparable rate of fall of bilirubin level to continuous PT (CPT) and results in lesser side effects and better acceptance.
Methods: In this non-inferiority trial, 174 neonates ≥35 wk gestation and >2000 g with jaundice requiring PT were randomized to receive either IPT (one hour on and two hours off) or CPT (with minimum interruptions for feeding) after device stratification [light-emitting diode (LED) or compact fluorescent light (CFL)]. Bilirubin was checked 12th hourly, and calcium, vitamin D and nitric oxide (NO) levels were analyzed along with the clinical side effects and nursing and maternal satisfaction scores (CTRI Registration No. CTRI/2018/01/011072).
Results: The rate of fall of bilirubin was similar in both the CPT and IPT groups [0.16 (0.10, 0.22) vs. 0.13 (0.09, 0.20) mg/dl/h, P=0.22]. The median difference with 95 per cent confidence interval of 0.03 (0.03, 0.03) mg/dl was also within the pre-defined inferiority limits. There was no significant change in the duration of PT and side effects such as fall in calcium levels, rise in vitamin D and NO levels or the clinical side effects. Maternal satisfaction favoured the IPT group, but the nurses opined that IPT was difficult to implement. Subgroup analysis for PT devices used showed that efficacy of both CFL and LED devices was equivalent.
Interpretation & conclusions: IPT was non-inferior to CPT in reducing bilirubin levels in ≥35 wk neonates, irrespective of device used, and also mothers reported better satisfaction with IPT. Although IPT appears promising, CPT does not increase clinical and biochemical side effects compared to IPT.
中文翻译：
妊娠 35 周以上高胆红素血症新生儿间歇性光疗与连续性光疗的疗效、安全性和满意度比较：一项随机对照试验
背景与目标：光疗 (PT) 已成为治疗新生儿黄疸的标准护理。本研究旨在确定间歇性 PT (IPT) 是否导致胆红素水平下降的速度与连续性 PT (CPT) 相当，并导致副作用更小和接受度更高。
方法：在这项非劣效性试验中，174 名妊娠≥35 周且>2000 g 黄疸需要 PT 的新生儿在设备分层后随机接受 IPT（开一小时和两小时停）或 CPT（最少中断喂养） [发光二极管 (LED) 或紧凑型荧光灯 (CFL)]。12日检查胆红素每小时分析钙、维生素 D 和一氧化氮 (NO) 水平以及临床副作用以及护理和产妇满意度评分（CTRI 注册号 CTRI/2018/01/011072）。
结果： CPT 组和 IPT 组的胆红素下降率相似 [0.16 (0.10, 0.22) vs. 0.13 (0.09, 0.20) mg/dl/h, P=0.22]。95% 置信区间为 0.03 (0.03, 0.03) mg/dl 的中位数差异也在预先定义的劣势范围内。PT 持续时间和副作用（如钙水平下降、维生素 D 和 NO 水平升高）或临床副作用没有显着变化。产妇满意度有利于 IPT 组，但护士认为 IPT 难以实施。使用的 PT 设备的亚组分析表明，CFL 和 LED 设备的功效是相同的。
解释和结论：无论使用何种设备，IPT 在降低≥35 周新生儿胆红素水平方面均不劣于 CPT，并且母亲报告对 IPT 的满意度更高。尽管 IPT 看起来很有希望，但与 IPT 相比，CPT 不会增加临床和生化副作用。
更新日期：2021-04-01
Methods: In this non-inferiority trial, 174 neonates ≥35 wk gestation and >2000 g with jaundice requiring PT were randomized to receive either IPT (one hour on and two hours off) or CPT (with minimum interruptions for feeding) after device stratification [light-emitting diode (LED) or compact fluorescent light (CFL)]. Bilirubin was checked 12th hourly, and calcium, vitamin D and nitric oxide (NO) levels were analyzed along with the clinical side effects and nursing and maternal satisfaction scores (CTRI Registration No. CTRI/2018/01/011072).
Results: The rate of fall of bilirubin was similar in both the CPT and IPT groups [0.16 (0.10, 0.22) vs. 0.13 (0.09, 0.20) mg/dl/h, P=0.22]. The median difference with 95 per cent confidence interval of 0.03 (0.03, 0.03) mg/dl was also within the pre-defined inferiority limits. There was no significant change in the duration of PT and side effects such as fall in calcium levels, rise in vitamin D and NO levels or the clinical side effects. Maternal satisfaction favoured the IPT group, but the nurses opined that IPT was difficult to implement. Subgroup analysis for PT devices used showed that efficacy of both CFL and LED devices was equivalent.
Interpretation & conclusions: IPT was non-inferior to CPT in reducing bilirubin levels in ≥35 wk neonates, irrespective of device used, and also mothers reported better satisfaction with IPT. Although IPT appears promising, CPT does not increase clinical and biochemical side effects compared to IPT.
中文翻译：
妊娠 35 周以上高胆红素血症新生儿间歇性光疗与连续性光疗的疗效、安全性和满意度比较：一项随机对照试验
背景与目标：光疗 (PT) 已成为治疗新生儿黄疸的标准护理。本研究旨在确定间歇性 PT (IPT) 是否导致胆红素水平下降的速度与连续性 PT (CPT) 相当，并导致副作用更小和接受度更高。
方法：在这项非劣效性试验中，174 名妊娠≥35 周且>2000 g 黄疸需要 PT 的新生儿在设备分层后随机接受 IPT（开一小时和两小时停）或 CPT（最少中断喂养） [发光二极管 (LED) 或紧凑型荧光灯 (CFL)]。12日检查胆红素每小时分析钙、维生素 D 和一氧化氮 (NO) 水平以及临床副作用以及护理和产妇满意度评分（CTRI 注册号 CTRI/2018/01/011072）。
结果： CPT 组和 IPT 组的胆红素下降率相似 [0.16 (0.10, 0.22) vs. 0.13 (0.09, 0.20) mg/dl/h, P=0.22]。95% 置信区间为 0.03 (0.03, 0.03) mg/dl 的中位数差异也在预先定义的劣势范围内。PT 持续时间和副作用（如钙水平下降、维生素 D 和 NO 水平升高）或临床副作用没有显着变化。产妇满意度有利于 IPT 组，但护士认为 IPT 难以实施。使用的 PT 设备的亚组分析表明，CFL 和 LED 设备的功效是相同的。
解释和结论：无论使用何种设备，IPT 在降低≥35 周新生儿胆红素水平方面均不劣于 CPT，并且母亲报告对 IPT 的满意度更高。尽管 IPT 看起来很有希望，但与 IPT 相比，CPT 不会增加临床和生化副作用。
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