Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.
Department of Pediatrics, Mount Sinai Hospital, Toronto, Ontario, Canada.
J Pediatr. 2021 Aug;235:26-33.e2. doi: 10.1016/j.jpeds.2021.02.073. Epub 2021 Mar 7.
To evaluate the impact of prophylactic indomethacin on early death (<10 days after birth) or severe neurologic injury and on early death or spontaneous intestinal perforation by completed weeks of gestational age in neonates born <29 weeks of gestation.
This was a multicenter, retrospective cohort study of neonates (n = 12 515) born at 23 weeks of gestational age, admitted to neonatal intensive care units participating in the Canadian Neonatal Network who received prophylactic indomethacin started within the first 12 hours after birth. Univariate and multivariate analysis compared the composite outcomes of early death or severe neurologic injury and early death or spontaneous intestinal perforation.
Of 12 515 eligible neonates, 1435 (11.5%) were exposed to prophylactic indomethacin; recipients were of lower gestational age and birth weight and had greater severity of illness (Score of Neonatal Acute Physiology with Perinatal Extension) on admission compared with nonrecipients. After we adjusted for confounders, prophylactic indomethacin was associated with reduced odds of early death or severe neurologic injury and early death or spontaneous intestinal perforation in neonates born at 23-24 weeks of gestational age. However, prophylactic indomethacin was associated with increased odds of early mortality or spontaneous intestinal perforation for neonates born at 26-28 weeks of gestational age.
Prophylactic indomethacin use was associated with benefit in neonates born at 23-24 weeks of gestational age, but with harm at 26-28 weeks of gestational age. Given the observation of significantly improved survival, a randomized controlled trial is needed to investigate the effect of prophylactic indomethacin in babies born at 23-25 weeks of gestational age.
评估预防性使用吲哚美辛对 29 孕周以下新生儿出生后 10 天内死亡或严重神经损伤，以及完成妊娠周数时的早期死亡或自发性肠穿孔的影响。
这是一项多中心、回顾性队列研究，纳入了在加拿大新生儿网络参与单位接受治疗的 12515 例 23 孕周出生、入住新生儿重症监护病房的新生儿。所有新生儿均在出生后 12 小时内接受预防性吲哚美辛治疗。单变量和多变量分析比较了早期死亡或严重神经损伤与早期死亡或自发性肠穿孔的复合结局。
在 12515 例符合条件的新生儿中，1435 例（11.5%）接受了预防性吲哚美辛治疗；与未接受治疗的新生儿相比，接受预防性吲哚美辛治疗的新生儿胎龄和出生体重更小，入院时疾病严重程度更高（新生儿急性生理学与围产期延伸评分）。在调整混杂因素后，23-24 孕周出生的新生儿使用预防性吲哚美辛与降低早期死亡或严重神经损伤与早期死亡或自发性肠穿孔的风险相关，但 26-28 孕周出生的新生儿使用预防性吲哚美辛与早期死亡率或自发性肠穿孔的风险增加相关。
预防性使用吲哚美辛对 23-24 孕周出生的新生儿有益，但对 26-28 孕周出生的新生儿有害。鉴于观察到生存率显著提高，需要进行一项随机对照试验来研究预防性使用吲哚美辛对 23-25 孕周出生婴儿的影响。
