Balasubramanian Haribalakrishna, Jain Vaibhav, Bhalgat Parag, Parikh Shalin, Kabra Nandkishore, Mohan Diwakar, Sheth Kshitij
Department of Neonatology, Surya Hospitals, Mumbai, Maharashtra, India
Department of Neonatology, Surya Hospitals, Mumbai, Maharashtra, India.
Arch Dis Child Fetal Neonatal Ed. 2023 Mar;108(2):130-135. doi: 10.1136/archdischild-2022-323781. Epub 2022 Aug 8.
To compare the efficacy of low dose-short course intravenous paracetamol with a conventional dose regimen for early targeted closure of patent ductus arteriosus (PDA).
Single-centre, double-blinded, active controlled, randomised non-inferiority trial.
Level III neonatal intensive care unit in Western India.
Preterm infants <30 weeks of gestation requiring mechanical ventilation, or continuous positive airway pressure with FiO ≥0.35 and diagnosed with a haemodynamically significant PDA (hsPDA) at 18-24 hours of postnatal age.
Low dose (10 mg/kg/dose 6 hourly for 72 hours) versus conventional dose (15 mg/kg/dose 6 hourly for 120 hours) intravenous paracetamol treatment.
Comparison of the rates of ductal closure at completion of sixth postnatal day, using a prespecified non-inferiority margin of 20%.
A total of 102 infants were enrolled. The median gestational age and birth weight of the included infants were 26.4 weeks and 830 g. At completion of the sixth postnatal day, closure of PDA was achieved in 92% of infants in the low dose group as compared with 94% of those in the standard dose group (risk difference: -1.6%, 95% CI: -11.6% to 8.5%, p=0.38). The rates of rescue therapies, adverse effects and other neonatal morbidities were comparable in both groups.
In very preterm infants on significant respiratory support, low dose-short course intravenous paracetamol treatment was non-inferior to a conventional dosing regime of paracetamol for closure of hsPDA in the first week of postnatal age. Larger studies with narrow margins of non-inferiority are required to confirm our findings.
CTRI/2017/10/010012.
比较低剂量短疗程静脉注射对乙酰氨基酚与传统剂量方案在早期目标性关闭动脉导管未闭（PDA）方面的疗效。
单中心、双盲、活性对照、随机非劣效性试验。
印度西部的三级新生儿重症监护病房。
孕周<30周、需要机械通气或持续气道正压通气且吸入氧分数≥0.35，并在出生后18 - 24小时被诊断为血流动力学显著的动脉导管未闭（hsPDA）的早产儿。
低剂量（10mg/kg/剂量，每6小时一次，共72小时）与传统剂量（15mg/kg/剂量，每6小时一次，共120小时）静脉注射对乙酰氨基酚治疗。
使用预先设定的20%的非劣效性界值，比较出生后第6天结束时导管闭合率。
共纳入102例婴儿。纳入婴儿的中位孕周和出生体重分别为26.4周和830g。出生后第6天结束时，低剂量组92%的婴儿实现了PDA闭合，标准剂量组为94%（风险差异：-1.6%，95%CI：-11.6%至8.5%，p = 0.38）。两组的挽救治疗率、不良反应和其他新生儿疾病发生率相当。
在接受显著呼吸支持的极早产儿中，低剂量短疗程静脉注射对乙酰氨基酚治疗在出生后第一周关闭hsPDA方面不劣于传统对乙酰氨基酚给药方案。需要进行非劣效性界值更窄的更大规模研究来证实我们的发现。
CTRI/2017/10/010012。
