Department of Neonatology, National Maternity Hospital, Dublin, Ireland.
School of Medicine, University College Dublin, Dublin, Ireland.
JAMA Pediatr. 2018 Jul 1;172(7):664-669. doi: 10.1001/jamapediatrics.2018.0623.
Treatment options for a symptomatic pneumothorax in newborns include needle aspiration (NA) and chest drain (CD) insertion. There is little consensus as to the preferred treatment, reflecting a lack of evidence from clinical trials.
To investigate whether treating pneumothoraces diagnosed on chest radiography (CR) in newborns receiving respiratory support with NA results in fewer infants having CDs inserted within 6 hours of diagnosis.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial was conducted from October 7, 2013, to December 21, 2016. The setting was 5 tertiary European neonatal intensive care units. Infants receiving respiratory support (endotracheal ventilation, continuous positive airway pressure, or supplemental oxygen >40%) who had a pneumothorax on CR that clinicians deemed needed treatment were eligible for inclusion.
Infants were randomly assigned (1:1) to drainage using NA or CD insertion, stratified by center and gestation at birth (<32 vs ≥32 weeks). Caregivers were not masked to group assignment. For NA, a needle was inserted between the ribs to aspirate air and was removed once air was no longer aspirated. A CD was inserted if clinicians deemed that the response was inadequate. For CD insertion, a drain was inserted between the ribs and was left in situ.
The primary outcome was whether a CD was inserted on the side of the pneumothorax within 6 hours of diagnosis.
A total of 76 infants were randomly assigned, and 6 (4 assigned to NA and 2 to CD) were excluded because they met exclusion criteria at enrollment. Of the 70 remaining infants, 33 (16 male [48%]) were assigned to NA and 37 (22 male [59%]) to CD insertion. Their median (interquartile range [IQR]) gestational age was 31 (27-38) vs 31 (27-35) weeks, and their median (IQR) birth weight was 1385 (1110-3365) vs 1690 (1060-2025) g, respectively. Fewer infants assigned to NA had a CD inserted within 6 hours (55% [18 of 33] vs 100% [37 of 37]; relative risk, 0.55; 95% CI, 0.40-0.75) and during hospitalization (70% [23 of 33] vs 100% [37 of 37]; relative risk, 0.70, 95% CI, 0.56-0.87).
Needle aspiration reduced the rate of CD insertion in symptomatic newborns with pneumothorax on CR. It should be used as the initial method of draining radiologically confirmed pneumothorax in symptomatic infants.
isrctn.org Identifier: ISRCTN65161530.
治疗新生儿症状性气胸的方法包括针吸（NA）和胸腔引流（CD）插入。对于首选的治疗方法，尚未达成共识，这反映了临床试验缺乏证据。
调查在接受呼吸支持的新生儿中，对胸部 X 线（CR）诊断的气胸进行 NA 治疗，是否会导致在诊断后 6 小时内插入 CD 的婴儿数量减少。
设计、地点和参与者：这是一项从 2013 年 10 月 7 日至 2016 年 12 月 21 日进行的随机临床试验。地点为欧洲 5 家三级新生儿重症监护病房。有接受呼吸支持（气管内通气、持续气道正压或补充氧气>40%）的患儿，CR 上有气胸，临床医生认为需要治疗，符合纳入标准。
患儿被随机分配（1:1）接受 NA 或 CD 插入治疗，按中心和出生时的胎龄（<32 周与≥32 周）分层。医护人员对分组情况不知情。对于 NA，在肋骨之间插入一根针以抽吸空气，一旦不再抽吸空气就将其取出。如果医生认为反应不足，将插入 CD。对于 CD 插入，将引流管插入肋骨之间并留在原位。
主要结局是在诊断后 6 小时内，是否在气胸的一侧插入 CD。
共有 76 名患儿被随机分配，其中 6 名（4 名分配到 NA，2 名分配到 CD）因在入组时符合排除标准而被排除。在剩余的 70 名患儿中，33 名（16 名男性[48%]）被分配到 NA，37 名（22 名男性[59%]）被分配到 CD 插入。他们的中位（四分位距[IQR]）胎龄为 31（27-38）周，中位（IQR）出生体重为 1385（1110-3365）g 和 1690（1060-2025）g，分别。接受 NA 治疗的患儿在 6 小时内（55%[18 例] vs 100%[37 例]；相对风险，0.55；95%CI，0.40-0.75）和住院期间（70%[23 例] vs 100%[37 例]；相对风险，0.70，95%CI，0.56-0.87）插入 CD 的患儿较少。
NA 降低了 CR 显示症状性气胸的新生儿中 CD 插入的比率。它应该作为治疗有症状的婴儿放射学确认的气胸的初始方法。
isrctn.org 标识符：ISRCTN65161530。
