Social Determinants of Health Research Center, Research Institute for Health Development, Kurdistan University of Medical Sciences, Sanandaj, Iran.
Cancer and Immunology Research Center, Research Institute for Health Development, Kurdistan University of Medical Sciences, Sanandaj, Iran.
Eur J Pediatr. 2024 Nov;183(11):4649-4658. doi: 10.1007/s00431-024-05739-5. Epub 2024 Aug 22.
Previous investigations on the impact of oral zinc sulfate treatment on newborns' serum bilirubin levels have produced conflicting results. As a result, the goal of this clinical study was to evaluate how oral zinc sulfate affected the levels of serum bilirubin in term infants who were admitted to the neonatal intensive care unit. The study was conducted at the Neonatal Care Unit of Besat Hospital in Sanandaj, Kurdistan Province, as a double-blind randomized controlled trial. The participants included term infants (37-42 weeks of gestation) who required phototherapy and were admitted to the neonatal intensive care unit. A total of 290 infants were enrolled and randomly divided into two groups. The intervention group received oral zinc sulfate supplementation at a dosage of 1 mg/kg per day in addition to phototherapy, while the placebo group received an equivalent amount of placebo daily. Bilirubin measurements were obtained at the initiation of the intervention and subsequently every 24 h until discharge. The collected data were analyzed using STATA software version 17. After the infants were randomly allocated to the zinc-sulfate and placebo groups, the study outcomes, including the average changes in bilirubin levels after intervention, the hours of phototherapy, and the number of days of hospitalization, were analyzed and compared for a total of 160 infants in the zinc sulfate group and 130 infants in the placebo group. The reduction in bilirubin levels in infants receiving zinc sulfate was (- 3.75 ± 0.19 CI 95% - 4.12, - 3.37) and for placebo group was (- 1.81 ± 0.15 CI 95% - 2.12, - 1.50) 24 h after the intervention. Furthermore, 48 and 72 h following the intervention, bilirubin levels in the intervention group demonstrated a more substantial decline. The zinc sulfate group had a shorter hospital stay (2.13 ± 0.04 vs. 2.83 ± 1.42) and required less phototherapy hours than the placebo group (6.21 ± 2.16 vs. 8.78 ± 1.40). Conclusions: Oral zinc sulfate supplementation in term neonates with hyperbilirubinemia decreased the level of bilirubin levels, duration of phototherapy, and hospital stay. Trial registration: IRCT, IRCT20220806055625N1. Study Registered 25 December 2022, http://irct.ir/trial/66,722 .
先前关于口服硫酸锌治疗对新生儿血清胆红素水平影响的研究结果相互矛盾。因此,本项临床研究的目的是评估口服硫酸锌对入住新生儿重症监护病房的足月婴儿血清胆红素水平的影响。该研究在库尔德斯坦省 Sanandaj 的 Besat 医院新生儿科进行,采用双盲随机对照试验设计。参与者为需要光疗并入住新生儿重症监护病房的足月婴儿(37-42 周妊娠)。共有 290 名婴儿入组,并随机分为两组。干预组在接受光疗的同时,每天口服 1 毫克/公斤的硫酸锌补充剂,而安慰剂组每天接受等量的安慰剂。在干预开始时和随后的每 24 小时测量胆红素水平,直到出院。使用 STATA 软件版本 17 分析收集的数据。在婴儿被随机分配到硫酸锌组和安慰剂组后,对锌组和安慰剂组各 160 名和 130 名婴儿的干预后胆红素水平平均变化、光疗时间和住院天数等研究结果进行了分析和比较。接受硫酸锌治疗的婴儿的胆红素水平下降(-3.75±0.19 CI 95%:-4.12,-3.37),而安慰剂组下降(-1.81±0.15 CI 95%:-2.12,-1.50)为干预后 24 小时。此外,干预后 48 和 72 小时,干预组的胆红素水平下降更为明显。硫酸锌组的住院时间更短(2.13±0.04 与 2.83±1.42),光疗时间也比安慰剂组更少(6.21±2.16 与 8.78±1.40)。结论:口服硫酸锌补充剂可降低高胆红素血症足月新生儿的胆红素水平、光疗时间和住院时间。试验注册:IRCT,IRCT20220806055625N1。研究于 2022 年 12 月 25 日注册,http://irct.ir/trial/66,722 。