MacLellan Abigale, Cameron-Nola Austin J, Cooper Chris, Mitra Souvik
Faculty of Medicine, Dalhousie University, Halifax, Canada.
Division of Neonatal Perinatal Medicine, Department of Pediatrics, Dalhousie University & IWK Health Centre, Halifax, Canada.
Cochrane Database Syst Rev. 2024 Dec 18;12(12):CD015424. doi: 10.1002/14651858.CD015424.pub2.
The ductus arteriosus is a blood vessel connecting the main pulmonary artery and the proximal descending aorta. After birth, the ductus arteriosus usually closes completely. However, sometimes it remains patent in the neonate, which is called patent ductus arteriosus (PDA). If a PDA is clinically symptomatic, it can lead to overcirculation in the lungs, and reduced perfusion to the gut and kidneys. Most clinical practice guidelines suggest fluid restriction as a conservative management strategy for the treatment of symptomatic PDA. Restricting fluid has been shown to reduce the incidence of PDA in older preterm infants. However, aggressive restriction of fluids may affect systemic blood flow in extremely preterm infants. Given the potential adverse effects, it is important to systematically evaluate the evidence on the use of fluid restriction to treat symptomatic PDA to inform clinical decisions.
To assess the effects of fluid restriction on morbidity and mortality for symptomatic PDA in preterm infants.
We searched CENTRAL, MEDLINE, and Embase in October 2023. We also searched Clinicaltrials.gov, ICTRP, ANZCTR, and Epistemonikos. We planned to search the reference list of included studies and relevant systematic reviews for studies not identified by the database searches, but did not identify any.
We planned to include randomized controlled trials (RCTs), quasi-RCTs, cluster-RCTs, and cross-over RCTs. We planned to include neonates who were born preterm (less than 37 weeks' gestational age), or with low birth weight (less than 2500 g), with a symptomatic PDA, diagnosed either clinically or by echocardiographic criteria, in the neonatal period. We planned to include studies that compared therapeutic restriction of parenteral or enteral fluids, or both, with or without diuretics, with control groups that received standard fluid intake, defined as no parenteral or enteral restriction, with or without diuretic use.
We used standard Cochrane methods. Our primary outcome was closure of PDA. Other relevant outcomes were all-cause mortality by 36 weeks' postmenstrual age, need for interventional closure of the PDA, need for treatment with a cyclooxygenase inhibitor, bronchopulmonary dysplasia, severe intraventricular hemorrhage, and duration of hospitalization. We planned to use GRADE to assess the certainty of evidence for each outcome.
We did not identify any completed or ongoing RCTs that met our inclusion criteria and explored the effectiveness and safety of fluid restriction to treat symptomatic PDA.
AUTHORS' CONCLUSIONS: No evidence from RCTs is currently available to evaluate the benefits and harms of fluid restriction for the treatment of symptomatic patent ductus arteriosus in preterm infants. We identified no ongoing studies. Evidence from sufficiently powered RCTs evaluating fluid restriction for treatment of symptomatic PDA in preterm neonates is needed to inform clinical decisions.
动脉导管是连接主肺动脉和近端降主动脉的血管。出生后,动脉导管通常会完全闭合。然而,有时新生儿的动脉导管仍保持开放,这被称为动脉导管未闭(PDA)。如果PDA出现临床症状,可导致肺部血流过多,以及肠道和肾脏灌注减少。大多数临床实践指南建议限制液体摄入作为治疗有症状PDA的保守管理策略。已表明限制液体摄入可降低较大孕周早产儿PDA的发生率。然而,积极限制液体摄入可能会影响极早产儿的全身血流。鉴于潜在的不良影响,系统评估限制液体摄入治疗有症状PDA的证据以指导临床决策非常重要。
评估限制液体摄入对早产儿有症状PDA的发病率和死亡率的影响。
我们于2023年10月检索了Cochrane中心对照试验注册库、MEDLINE和Embase。我们还检索了Clinicaltrials.gov、国际临床试验注册平台(ICTRP)、澳大利亚和新西兰临床试验注册中心(ANZCTR)以及Epistemonikos。我们计划检索纳入研究的参考文献列表和相关系统评价,以查找数据库检索未识别的研究,但未找到任何相关研究。
我们计划纳入随机对照试验(RCT)、半随机对照试验、整群随机对照试验和交叉随机对照试验。我们计划纳入孕周小于37周或出生体重小于2500g的早产儿,这些早产儿在新生儿期患有有症状的PDA,通过临床或超声心动图标准诊断。我们计划纳入比较肠外或肠内液体治疗性限制(有或没有利尿剂)与接受标准液体摄入量(定义为无肠外或肠内限制,有或没有使用利尿剂)的对照组的研究。
我们采用标准的Cochrane方法。我们的主要结局是PDA闭合。其他相关结局包括孕龄36周时的全因死亡率、PDA介入闭合的需求、使用环氧化酶抑制剂治疗的需求、支气管肺发育不良、重度脑室内出血以及住院时间。我们计划使用GRADE评估每个结局的证据确定性。
我们未找到任何符合我们纳入标准且探讨限制液体摄入治疗有症状PDA的有效性和安全性的已完成或正在进行的RCT。
目前尚无RCT证据可用于评估限制液体摄入治疗早产儿有症状动脉导管未闭的益处和危害。我们未找到正在进行的研究。需要来自足够样本量的RCT的证据来评估限制液体摄入治疗早产儿有症状PDA的效果,以指导临床决策。