Bruschettini Matteo, Moresco Luca, Calevo Maria Grazia, Romantsik Olga
Lund University, Skåne University Hospital, Department of Clinical Sciences Lund, Paediatrics, Lund, Sweden.
Skåne University Hospital, Cochrane Sweden, Wigerthuset, Remissgatan 4, first floor, room 11-221, Lund, Sweden, 22185.
Cochrane Database Syst Rev. 2020 Mar 17;3(3):CD013222. doi: 10.1002/14651858.CD013222.pub2.
Transient tachypnoea of the newborn (TTN) is characterized by tachypnoea and signs of respiratory distress. Transient tachypnoea typically appears within the first two hours of life in term and late preterm newborns. The administration of corticosteroids might compensate for the impaired hormonal changes which occur when infants are delivered late preterm, or at term but before the onset of spontaneous labour (elective caesarean section). Corticosteroids might improve the clearance of liquid from the lungs, thus reducing the effort required to breathe and improving respiratory distress.
The objective of this review is to assess whether postnatal corticosteroids - compared to placebo, no treatment or any other drugs administered to treat TTN - are effective and safe in the treatment of TTN in infants born at 34 weeks' gestational age or more.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 2), MEDLINE (1996 to 19 February 2019), Embase (1980 to 19 February 2019) and CINAHL (1982 to 19 February 2019). We applied no language restrictions. We searched clinical trial registries for ongoing studies.
We included randomized controlled trials, quasi-randomized controlled trials and cluster-randomized trials comparing postnatal corticosteroids versus placebo or no treatment or any other drugs administered to infants born at 34 weeks' gestational age or more and less than three days of age with TTN.
For each of the included trials, two review authors independently extracted data (e.g. number of participants, birth weight, gestational age, duration of oxygen therapy, need for continuous positive airway pressure, need for mechanical ventilation, duration of mechanical ventilation, etc.) and assessed the risk of bias (e.g. adequacy of randomization and blinding, completeness of follow-up). The primary outcomes considered in this review were need for nasal continuous positive airway pressure and need for mechanical ventilation. We used the GRADE approach to assess the certainty of the evidence.
One trial, which included 49 infants, met the inclusion criteria. The trial compared the use of inhaled corticosteroids (budesonide) with placebo. We found no differences between groups in terms of need for nasal continuous positive airway pressure (risk ratio (RR) 1.27, 95% confidence interval (CI) 0.65 to 2.51; 1 study, 49 participants) and need for mechanical ventilation (RR 0.52, 95% CI 0.05 to 5.38; 1 study, 49 participants). The type of mechanical ventilation used in the included study was high-frequency oscillation. Tests for heterogeneity were not applicable for any of the analyses as only one study was included. Out of the secondary outcomes we deemed to be of greatest importance to patients, the study only reported on duration of hospital stay, which was no different between groups. The quality of the evidence is very low, due to the imprecision of the estimates and indirectness. We identified no ongoing trials.
AUTHORS' CONCLUSIONS: Given the paucity and very low quality of the available evidence, we are unable to determine the benefits and harms of postnatal administration of either inhaled or systemic corticosteroids for the management of TTN.
新生儿暂时性呼吸急促(TTN)的特征为呼吸急促和呼吸窘迫体征。TTN通常在足月儿和晚期早产儿出生后的头两小时内出现。当婴儿为晚期早产儿或足月儿但在自然分娩开始前(择期剖宫产)出生时,给予皮质类固醇可能会弥补发生受损的激素变化。皮质类固醇可能会改善肺部液体的清除,从而减少呼吸所需的努力并改善呼吸窘迫。
本综述的目的是评估与安慰剂、不治疗或用于治疗TTN的任何其他药物相比,产后皮质类固醇对孕34周及以上出生的婴儿治疗TTN是否有效和安全。
我们检索了Cochrane对照试验中央注册库(CENTRAL;2019年第2期)、MEDLINE(1996年至2019年2月19日)、Embase(1980年至2019年2月19日)和CINAHL(1982年至2019年2月19日)。我们未设语言限制。我们检索了临床试验注册库以查找正在进行的研究。
我们纳入了随机对照试验、半随机对照试验和整群随机试验,这些试验比较了产后皮质类固醇与安慰剂、不治疗或用于孕34周及以上、出生后不到三天且患有TTN的婴儿的任何其他药物。
对于每项纳入的试验,两位综述作者独立提取数据(例如参与者数量、出生体重、孕周、氧疗持续时间、持续气道正压通气需求、机械通气需求、机械通气持续时间等)并评估偏倚风险(例如随机化和盲法的充分性、随访的完整性)。本综述考虑的主要结局是鼻持续气道正压通气需求和机械通气需求。我们使用GRADE方法评估证据的确定性。
一项纳入49名婴儿的试验符合纳入标准。该试验比较了吸入性皮质类固醇(布地奈德)与安慰剂的使用。我们发现两组在鼻持续气道正压通气需求(风险比(RR)1.27,95%置信区间(CI)0.65至2.51;1项研究,49名参与者)和机械通气需求(RR 0.52,95%CI 0.05至5.38;1项研究,49名参与者)方面没有差异。纳入研究中使用的机械通气类型为高频振荡。由于仅纳入了一项研究,因此异质性检验不适用于任何分析。在我们认为对患者最重要的次要结局中,该研究仅报告了住院时间,两组之间没有差异。由于估计的不精确性和间接性,证据质量非常低。我们未识别到正在进行的试验。
鉴于现有证据匮乏且质量极低,我们无法确定产后吸入或全身性皮质类固醇用于管理TTN的益处和危害。