Rambam Medical Center & Rapport Faculty of Medicine, Haifa, Israel.
Bnai Zion Medical Center & Rapport Faculty of Medicine, Haifa, Israel.
JAMA Pediatr. 2021 Jan 1;175(1):36-43. doi: 10.1001/jamapediatrics.2020.3579.
Use of cannulas with long and narrow tubing (CLNT) has gained increasing popularity for applying noninvasive respiratory support for newborn infants thanks to ease of use, perceived patient comfort, and reduced nasal trauma. However, there is concern that this interface delivers reduced and suboptimal support.
To determine whether CLNT is noninferior to short binasal prongs and masks (SPM) when providing nasal intermittent positive pressure ventilation (NIPPV) in preterm infants.
DESIGN, SETTING, AND PARTICIPANTS: This randomized controlled, unblinded, prospective noninferiority trial was conducted between December 2017 and December 2019 at 2 tertiary neonatal intensive care units. Preterm infants born between 24 weeks' and 33 weeks and 6 days' gestation were eligible if presented with respiratory distress syndrome with the need for noninvasive ventilatory support either as initial treatment after birth or after first extubation. Analysis was performed by intention to treat.
Randomization to NIPPV with either CLNT or SPM interface.
The primary outcome was the need for intubation within 72 hours after NIPPV treatment began. Noninferiority margin was defined as 15% or less absolute difference.
Overall, 166 infants were included in this analysis, and infant characteristics and clinical condition (including fraction of inspired oxygen, Pco2, and pH level) were comparable at recruitment in the CLNT group (n = 83) and SPM group (n = 83). The mean (SD) gestational age was 29.3 (2.2) weeks vs 29.2 (2.5) weeks, and the mean (SD) birth weight was 1237 (414) g vs 1254 (448) g in the CLNT and SPM groups, respectively. Intubation within 72 hours occurred in 12 of 83 infants (14%) in the CLNT group and in 15 of 83 infants (18%) in the SPM group (risk difference, -3.6%; 95% CI, -14.8 to 7.6 [within the noninferiority margin], χ2 P = .53). Moderate to severe nasal trauma was significantly less common in the CLNT group compared with the SPM group (4 [5%] vs 14 [17%]; P = .01). There were no differences in other adverse events or in the course during hospitalization.
In this study, CLNT was noninferior to SPM in providing NIPPV for preterm infants, while causing significantly less nasal trauma.
ClinicalTrials.gov Identifier: NCT03081611.
由于使用方便、患者舒适度高、减少鼻腔创伤，带有长而细管的套管（CLNT）在为新生儿应用无创呼吸支持方面越来越受欢迎。然而，有人担心这种接口提供的支持减少且不理想。
确定 CLNT 在为早产儿提供经鼻间歇正压通气（NIPPV）时是否不如短鼻双叉管和面罩（SPM）。
设计、地点和参与者：这是一项于 2017 年 12 月至 2019 年 12 月在 2 家三级新生儿重症监护病房进行的随机对照、非盲、前瞻性非劣效性试验。如果 24 周至 33 周零 6 天胎龄的早产儿出现呼吸窘迫综合征，需要无创通气支持，无论是出生后初始治疗还是首次拔管后，均有资格参加。分析按意向治疗进行。
随机分配接受 CLNT 或 SPM 接口的 NIPPV。
主要结局是 NIPPV 治疗开始后 72 小时内需要插管。非劣效性边界定义为 15%或更低的绝对差异。
总体而言，这项分析共纳入了 166 名婴儿，CLNT 组（n=83）和 SPM 组（n=83）在接受治疗时婴儿的特征和临床状况（包括吸入氧分数、Pco2 和 pH 值）相似。CLNT 组和 SPM 组的平均（SD）胎龄分别为 29.3（2.2）周和 29.2（2.5）周，平均（SD）出生体重分别为 1237（414）g 和 1254（448）g。CLNT 组中有 12 名（14%）婴儿和 SPM 组中有 15 名（18%）婴儿在 72 小时内插管（风险差异，-3.6%；95%CI，-14.8 至 7.6[在非劣效性范围内]，χ2 P=.53）。与 SPM 组相比，CLNT 组中度至重度鼻腔创伤明显较少（4 [5%] vs 14 [17%]；P=.01）。其他不良事件或住院期间的病程没有差异。
在这项研究中，CLNT 在为早产儿提供 NIPPV 方面与 SPM 一样有效，同时引起的鼻腔创伤明显更小。
ClinicalTrials.gov 标识符：NCT03081611。
