Department of Paediatrics: Child and Youth Health, The University of Auckland, Auckland, New Zealand.
Starship Child Health, Auckland District Health Board, Auckland, New Zealand.
Arch Dis Child Fetal Neonatal Ed. 2023 Mar;108(2):106-113. doi: 10.1136/archdischild-2022-324010. Epub 2022 Aug 29.
To establish the most effective and best tolerated dose of caffeine citrate for the prevention of intermittent hypoxaemia (IH) in late preterm infants.
Phase IIB, double-blind, five-arm, parallel, randomised controlled trial.
Neonatal units and postnatal wards of two tertiary maternity hospitals in New Zealand.
Late preterm infants born at 34-36 weeks' gestation, recruited within 72 hours of birth.
Infants were randomly assigned to receive a loading dose (10, 20, 30 or 40 mg/kg) followed by 5, 10, 15 or 20 mg/kg/day equivolume enteral caffeine citrate or placebo daily until term corrected age.
IH (events/hour with oxygen saturation concentration ≥10% below baseline for ≤2 min), 2 weeks postrandomisation.
132 infants with mean (SD) birth weight 2561 (481) g and gestational age 35.7 (0.8) weeks were randomised (24-28 per group). Caffeine reduced the rate of IH at 2 weeks postrandomisation (geometric mean (GM): 4.6, 4.6, 2.0, 3.8 and 1.7 events/hour for placebo, 5, 10, 15 and 20 mg/kg/day, respectively), with differences statistically significant for 10 mg/kg/day (GM ratio (95% CI] 0.39 (0.20 to 0.76]; p=0.006) and 20 mg/kg/day (GM ratio (95% CI] 0.33 (0.17 to 0.68]; p=0.003) compared with placebo. The 20 mg/kg/day dose increased mean (SD) pulse oximetry oxygen saturation (SpO) (97.2 (1.0) vs placebo 96.0 (0.8); p<0.001), and reduced median (IQR) percentage of time SpO <90% (0.5 (0.2-0.8) vs 1.1 (0.6-2.4); p<0.001) at 2 weeks, without significant adverse effects on growth velocity or sleeping.
Caffeine reduces IH in late preterm infants at 2 weeks of age, with 20 mg/kg/day being the most effective dose.
ACTRN12618001745235.
确定柠檬酸咖啡因预防晚期早产儿间歇性低氧血症（IH）的最佳有效且耐受良好的剂量。
IIB 期、双盲、五臂、平行、随机对照试验。
新西兰两家三级妇产医院的新生儿病房和产后病房。
出生于 34-36 周妊娠的晚期早产儿，在出生后 72 小时内招募。
婴儿随机接受负荷剂量（10、20、30 或 40 mg/kg），然后接受 5、10、15 或 20 mg/kg/天等容量的柠檬酸咖啡因或安慰剂，每天一次，直至校正胎龄足月。
随机分组后 2 周 IH（氧饱和度浓度下降≥10%并持续≤2 分钟的事件/小时）。
132 名婴儿的平均（SD）出生体重为 2561（481）g，平均（SD）胎龄为 35.7（0.8）周，随机分为 24-28 组。咖啡因降低了随机分组后 2 周 IH 的发生率（几何平均值（GM）：安慰剂组为 4.6、4.6、2.0、3.8 和 1.7 事件/小时，分别为 5、10、15 和 20 mg/kg/天），10 mg/kg/天的差异具有统计学意义（GM 比值（95%CI）0.39（0.20 至 0.76）；p=0.006）和 20 mg/kg/天（GM 比值（95%CI）0.33（0.17 至 0.68）；p=0.003）与安慰剂相比。20 mg/kg/天的剂量增加了平均（SD）脉搏血氧饱和度（SpO2）（97.2（1.0）与安慰剂 96.0（0.8）；p<0.001），并降低了 2 周时 SpO2<90%的中位数（IQR）（0.5（0.2-0.8）与 1.1（0.6-2.4）；p<0.001），但对生长速度或睡眠无显著不良影响。
咖啡因可降低晚期早产儿 2 周时 IH 的发生率，20 mg/kg/天是最有效的剂量。
ACTRN12618001745235。
