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评估对乙酰氨基酚与布洛芬联合用于闭合动脉导管的早产儿安全性和有效性的随机对照试验

2026年4月9日 更新者：Ramachandra Bhat、University of South Alabama

单中心、随机、双盲、安慰剂对照试验评估对乙酰氨基酚与布洛芬联合用于早产儿动脉导管闭合术的安全性和有效性

本研究的目的是确定早产儿静脉注射布洛芬和口服对乙酰氨基酚联合治疗血流动力学显着的动脉导管未闭是否比单独使用静脉注射布洛芬的标准治疗策略在关闭动脉导管方面具有更高的成功率。

研究概览

地位

终止

条件

干预/治疗

详细说明

该研究的主要目的是确认口服对乙酰氨基酚与静脉注射布洛芬同时给药对极低出生婴儿的安全性，并确定与仅静脉注射布洛芬治疗相比，其显着提高导管闭合率的功效。 因此，主要结果变量包括基于 2-D 经胸超声心动图证据的动脉导管未闭闭合成功率。

本研究为单中心、随机、双盲、安慰剂对照试验。 根据最佳产科估计，胎龄≤27 6/7 周的早产儿有资格入组。

对于随机化，研究人群将根据孕龄（GA ≤24 周和 > 25 周）分为两个亚组。 将使用计算机生成的随机序列进行随机化，使用 4 区组设计，1:1 并行分配。 分配包括治疗和控制臂。 治疗组将接受静脉注射布洛芬和口服对乙酰氨基酚的组合，而对照组将接受静脉注射布洛芬和口服安慰剂。

研究类型

介入性

注册 (实际的)

1

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Alabama
      • Mobile、Alabama、美国、36607
        • University of South Alabama

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

5天 至 3周 (孩子)

接受健康志愿者

不

描述

纳入标准：

  1. 早产儿≤27 6/7
  2. 获得父母的书面同意
  3. 婴儿需要呼吸支持

  4. 5 日龄后诊断为持续性动脉导管未闭（定义为以下至少两项：

    1. 导管尺寸 ≥ 1.5 mm
    2. 通过导管的最大流速 ≤ 2 m/s
    3. 左心房与主动脉之比 ≥ 1.4
    4. 宽脉压
    5. B 型钠尿肽 (BNP)
  5. 主治新生儿科医生决定治疗动脉导管未闭

排除标准：

  1. 未经父母同意
  2. 婴儿 > 产后 21 天
  3. 先天性异常，例如心脏或多发性异常
  4. 感染（例如败血症、肺炎）
  5. 出血性疾病或血小板计数< 50,000/ml
  6. 急性肾损伤 (AKI) 定义为少尿（尿量 < 0.5 毫升/千克/小时，持续 16 小时）和/或血清肌酐 > 1.5 毫克/分升
  7. 肝酶升高（正常上限的 2 倍以上）
  8. 肺动脉高压或经动脉导管右向左分流
  9. 坏死性小肠结肠炎的诊断
  10. 入组时无法耐受口服药物。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：ibuprofen and acetaminophen arm (intervention arm)
ibuprofen and acetaminophen will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Acetaminophen will be administered as oral formulation. Acetaminophen is given at a dose of 15 mg/Kg/dose, q 6 hours, for 3 days (total of 12 doses).
药品：布洛芬和对乙酰氨基酚
静脉注射布洛芬与口服对乙酰氨基酚同时给药
有源比较器：ibuprofen and placebo arm (control arm)
ibuprofen and acetaminophen will be administered concomitantly. Ibuprofen will be administered through intravenous route. The dose of ibuprofen will be the standard dosing regimen used in our unit: dosing based on the postnatal age. For Infants > 108 h of postnatal age: 18 mg/kg/dose loading dose followed by 9 mg/kg/dose, two doses at q24 intervals, started 24 h after the loading dose. Placebo will be sterile water, with similar volume and color as acetaminophen, will be given through the oro-gastric tube, for three days at 6 h intervals.
药品：布洛芬和安慰剂
静脉注射布洛芬与口服安慰剂同时给药

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Proportion of Participants With Ductus Arteriosus Closure/Constriction
大体时间：24-48 hours after the completion of study intervention
Ductal closure/constriction rate as defined based on the echocardiographic findings. Ductal closure/constriction will be defined as the complete closure of ductus or ductal diameter <1 mm
24-48 hours after the completion of study intervention

次要结果测量

结果测量
措施说明
大体时间
Echocardiographic Patent Ductus Arteriosus Parameters Before and After the Study Intervention
大体时间：24-48 hours after the completion of study intervention
Echocardiographic parameters including ductal size (PDA size in mm), Left atrium to aortic root ratio, ductal velocity, descending aortic diastolic flow, before and after the intervention. Between the group and within the group comparison
24-48 hours after the completion of study intervention
Ventilatory Settings Before and After the Study Intervention
大体时间：24-48 hours after the completion of study intervention
Ventilator parameters including Fio2, Mean airway pressure, Peak Inspiratory pressure, PEEP, and ventilatory rate oxygenation indices including Oxygenation index and Respiratory Severity score before and after intervention
24-48 hours after the completion of study intervention
Proportion of Participants With Liver Injury
大体时间：24-48 hours after the completion of study intervention
liver enzymes compared before and after the study intervention; if any significant elevation of liver enzymes from baseline, the participant classified as having liver injury
24-48 hours after the completion of study intervention
Proportion of Participants With Renal Injury
大体时间：24-48 hours after the completion of study intervention
Blood urea nitrogen (BUN) and serum creatinine before and after the study intervention are compared. Participants exhibiting significant elevation BUN and S creatine, are classified as having renal injury
24-48 hours after the completion of study intervention
Proportion of Participants With Hematological Adverse Events
大体时间：24-48 hours after the completion of study intervention
Hematocrit and platelet counts compared before and after the study intervention; if any significant alteration from baseline, the participant classified as having hematological adverse event,
24-48 hours after the completion of study intervention
Total Number of Days of Mechanical Ventilation
大体时间：from randomization until discharge/40 weeks post menstrual age
The total number of days on mechanical ventilation are counted as total duration of conventional mechanical ventilation plus high frequency ventilatory days
from randomization until discharge/40 weeks post menstrual age
Total Number of Days of Need for Supplemental Oxygen
大体时间：from randomization until discharge/40 weeks post menstrual age
Cumulative days on any supplemental O2 (including Mechanical ventilation., noninvasive ventilation, nasal cannula support) calculated from randomization until 4 weeks of postmenstrual age
from randomization until discharge/40 weeks post menstrual age
Duration of Noninvasive Ventilation
大体时间：from randomization until discharge/40 weeks post menstrual age
Total cumulative days on noninvasive ventilation, including NIPPV and nasal CPAP,
from randomization until discharge/40 weeks post menstrual age
Proportion of Participants With Persistence of Ductus-needing Pharmacological Treatment
大体时间：from randomization until discharge/40 weeks post menstrual age
Proportion of participants in each group requiring open label treatment with pharmacological agents for ductal closure, e.g. IV Ibuprofen or IV Acetaminophen or IV indomethacin therapies, as decided by the treating physician
from randomization until discharge/40 weeks post menstrual age
Proportion of Participants Requiring Surgical Ligation of PDA
大体时间：from randomization until discharge/40 weeks post menstrual age
Proportion of participants in each group requiring surgical ligation of persistent PDA for definitive surgical closure
from randomization until discharge/40 weeks post menstrual age
Proportion of Participants Developing Bronchopulmonary Dysplasia
大体时间：at 36 weeks post menstrual age
Proportion of participants diagnosed to have BPD based supplemental O2 requirement at 36 weeks' postmenstrual age
at 36 weeks post menstrual age
Percentage of Infants Requiring Home Oxygen Therapy
大体时间：at discharge/40 weeks post menstrual age
Proportion of participants in each group requiring home-based supplemental O2 therapy following the initial discharge from hospital.
at discharge/40 weeks post menstrual age
Proportion of Participants Developing Death Before Discharge
大体时间：until discharge/40 weeks post menstrual age
Proportion of participants in each group developing in-hospital death prior to 40 weeks of postmenstrual age.
until discharge/40 weeks post menstrual age
Time to Achieve Full Enteral Feeding
大体时间：from birth until discharge/40 weeks post menstrual age
Duration days during the postnatal period required to achieve an enteral feeding volume of 120 ml/kg/day.
from birth until discharge/40 weeks post menstrual age
Total Days on Total Parenteral Nutrition
大体时间：from birth until discharge/40 weeks post menstrual age
Cumulative days of receiving total parental nutrition from birth until the participant is discharged or reached postmenstrual age of 40 weeks
from birth until discharge/40 weeks post menstrual age
Proportion of Participants With Retinopathy of Prematurity
大体时间：from birth until discharge/40 weeks post menstrual age
Proportion of participants in each group diagnosed to have retinopathy of prematurity
from birth until discharge/40 weeks post menstrual age
Proportion of Participants Developing Spontaneous Intestinal Perforation
大体时间：from randomization until discharge/40 weeks post menstrual age
Proportion of participants developing or having the diagnosis of spontaneous intestinal perforation from randomization until discharge or 40 weeks' Postmenstrual age
from randomization until discharge/40 weeks post menstrual age
Proportion of Participants Developing Necrotizing Enterocolitis
大体时间：from randomization until discharge/40 weeks post menstrual age
Proportion of participants in each group with the diagnosis of medical or surgical Necrotizing Enterocolitis
from randomization until discharge/40 weeks post menstrual age
Proportion of Participants Developing Gastrointestinal Hemorrhage
大体时间：from randomization until discharge/40 weeks post menstrual age
Proportion of participants in each group developing gastrointestinal hemorrhage following randomization until discharge or postmenstrual age of 40 weeks
from randomization until discharge/40 weeks post menstrual age
Proportion of Participants Developing Late Onset Sepsis
大体时间：from randomization until discharge/40 weeks post menstrual age
Proportion of participants diagnosed to have either probable sepsis with minimum of 7 days of antibiotic therapy or culture proven sepsis
from randomization until discharge/40 weeks post menstrual age
Length of Hospital Stay
大体时间：from birth until discharge/40 weeks post menstrual age
Total duration (in days ) of hospital stay
from birth until discharge/40 weeks post menstrual age
Proportion of Participants With Periventricular Leukomalacia
大体时间：from randomization until discharge/40 weeks post menstrual age
Proportion of participants in each group with the evidence of periventricular leukomalacia on neurosonography
from randomization until discharge/40 weeks post menstrual age

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of South Alabama

调查人员

  • 研究主任：Fabien Eyal, MD、University of South Alabama

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年12月15日

初级完成 (实际的)

2020年10月30日

研究完成 (实际的)

2020年12月2日

研究注册日期

首次提交

2018年8月22日

首先提交符合 QC 标准的

2018年10月5日

首次发布 (实际的)

2018年10月9日

研究记录更新

最后更新发布 (实际的)

2026年4月30日

上次提交的符合 QC 标准的更新

2026年4月9日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 15-081/730216-8

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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