Department of Neonatology, Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital, New Delhi, India, 110001.
Sci Rep. 2022 Dec 19;12(1):21955. doi: 10.1038/s41598-022-23557-3.
There is growing evidence that less invasive surfactant administration (LISA) is a better alternative to the standard Intubate-surfactant-extubate (InSurE) procedure in spontaneously breathing preterm infants with RDS. The infant feeding tube is easily available and cost-effective in comparison to special catheters used for surfactant administration in various studies on LISA and cost-effective health care is the need of the hour for countries like ours which are Low and middle-income countries(LMICs).The present study was planned to compare the total duration of respiratory support in preterm babies between 26 to 34 weeks of gestation with RDS requiring surfactant therapy administered by LISA technique using an infant feeding tube or InSurE method. In this unblinded randomised controlled trial, 150 infants were allocated to LISA (n = 74) or InSurE group (n = 76). An 8F feeding tube was used for surfactant delivery in the LISA group. The primary outcome was the total duration of respiratory support required and secondary outcomes included the proportion of babies developing BPD, IVH, PDA, NEC, ROP, air leaks, CPAP failure, and those requiring a repeat dose of surfactant along with the duration of hospitalization, time to regain birth weight and Death. The baseline variables including birth weight and gestation age were similar in the two groups. Nearly 27% of the mothers did not receive any dose of antenatal steroids (ANS) while around 37% of the mothers received complete course of ANS. A high proportion of babies (57%) were delivered by cesarean section. Intrapharyngeal reflux was significantly more in babies who received surfactant with the LISA method in comparison to InSurE technique (32% v/s 3%, p < 0.001). There was no statistically significant difference in the primary outcome of the total duration of respiratory support in both groups with a median duration of 120 h, 95% CI (69-235), and p = 0.618. The need for invasive mechanical ventilation was significantly lower in the LISA group (p = 0.017) with RR (95% CI) 0.498 (0.259-0.958). The rate of CPAP failure was significantly lower in the LISA group (p = 0.005) with RR (95% CI) 0.55 (0.34-0.89). In this study, the total duration of hospital stay was reduced in the LISA group (19 days) compared to InSurE group (26 days), although the same was not statistically significant. LISA with an 8F feeding tube is feasible and an effective strategy for surfactant administration which resulted in a significant reduction in CPAP failure and the need for invasive mechanical ventilation.Trial registration: www.ctri.nic.in id CTRI/2020/05/025360. Trial was registered at CTRI on 26/05/2020. First case of trial was enrolled on 28/05/2020.
越来越多的证据表明，与标准的气管内表面活性物质给药-拔管-再插管（InSurE）程序相比，对于有 RDS 的自发性呼吸早产儿，微创表面活性物质给药（LISA）是一种更好的选择。与各种 LISA 研究中用于表面活性物质给药的特殊导管相比，婴儿喂养管更容易获得且具有成本效益，对于我们这样的中低收入国家（LMICs）来说，具有成本效益的医疗保健是当务之急。本研究旨在比较需要表面活性物质治疗的 26-34 周有 RDS 的早产儿，通过 LISA 技术使用婴儿喂养管或 InSurE 方法进行治疗时，总呼吸支持的持续时间。在这项非盲随机对照试验中，将 150 名婴儿随机分配到 LISA（n=74）或 InSurE 组（n=76）。LISA 组使用 8F 喂养管输送表面活性物质。主要结局是需要的总呼吸支持持续时间，次要结局包括发生 BPD、IVH、PDA、NEC、ROP、空气泄漏、CPAP 失败以及需要重复剂量表面活性物质的婴儿比例，以及住院时间、恢复出生体重时间和死亡。两组的基线变量（包括出生体重和胎龄）相似。近 27%的母亲未接受任何剂量的产前类固醇（ANS），而约 37%的母亲接受了完整疗程的 ANS。高比例的婴儿（57%）通过剖宫产分娩。与 InSurE 技术相比，接受 LISA 方法表面活性物质治疗的婴儿明显更容易发生咽内反流（32%比 3%，p<0.001）。两组的主要结局（总呼吸支持持续时间）无统计学差异，中位数持续时间为 120 小时，95%CI（69-235），p=0.618。LISA 组需要有创机械通气的比例明显降低（p=0.017），RR（95%CI）为 0.498（0.259-0.958）。LISA 组 CPAP 失败的发生率明显降低（p=0.005），RR（95%CI）为 0.55（0.34-0.89）。在这项研究中，与 InSurE 组（26 天）相比，LISA 组（19 天）的总住院时间缩短，但差异无统计学意义。使用 8F 喂养管的 LISA 是可行的，并且是一种有效的表面活性物质给药策略，可显著降低 CPAP 失败和有创机械通气的需求。试验注册：www.ctri.nic.in id CTRI/2020/05/025360。试验于 2020 年 5 月 26 日在 CTRI 注册。试验于 2020 年 5 月 28 日首次入组病例。
