Ramos-Navarro Cristina, Sánchez-Luna Manuel, Zeballos-Sarrato Susana, González-Pacheco Noelia
Complutense University, Gregorio Maraãon University Hospital, Neonatology Division, Biomedical Research Institute Gregorio Maraãon, Madrid/, Spain.
Clinics (Sao Paulo). 2016 Mar;71(3):128-34. doi: 10.6061/clinics/2016(03)02.
The aims of this study were to assess the efficacy and feasibility of a new, less invasive surfactant administration technique for beractant replacement using a specifically designed cannula in preterm infants born at <32 weeks of gestation and to compare short- and long-term outcomes between this approach and standard treatment, consisting of intubation, administration of surfactant and early extubation to nasal continuous positive airway pressure.
This was a single-center, prospective, open-label, non-randomized, controlled pilot study with an experimental cohort of 30 patients treated with less invasive surfactant administration and a retrospective control group comprising the 30 patients most recently treated with the standard approach. Beractant (4 ml/kg) was administered as an exogenous surfactant in both groups if patients on nasal continuous positive airway pressure during the first three days of life were in need of more than 30% FiO2. Clinicaltrials.gov: NCT02611284.
In the group with less invasive surfactant administration, beractant was successfully administered in all patients. Thirteen patients (43.3%) in the group with less invasive surfactant administration required invasive mechanical ventilation for more than 1 hour during the first 3 days of life, compared with 22 (73%) in the control group (p<0.036). The rate of requiring invasive mechanical ventilation for more than 48 hours was similar between the infants in the two groups (46% vs. 40%, respectively). There were no differences in other outcomes.
The administration of beractant (4 ml/kg) using a less invasive surfactant administration technique with a specifically designed cannula for administration is feasible. Moreover, early invasive mechanical ventilation exposure is significantly reduced by this method compared with the strategy involving intubation, surfactant administration and early extubation.
本研究旨在评估一种使用专门设计的插管进行贝拉克坦替代治疗的新型、侵入性较小的表面活性剂给药技术在孕周小于32周的早产儿中的疗效和可行性，并比较该方法与标准治疗（包括插管、表面活性剂给药和早期拔管至鼻持续气道正压通气）的短期和长期结局。
这是一项单中心、前瞻性、开放标签、非随机对照试验性研究，试验队列包括30例接受侵入性较小的表面活性剂给药治疗的患者，回顾性对照组包括最近接受标准治疗的30例患者。如果患者在出生后前三天接受鼻持续气道正压通气时需要的吸入氧分数超过30%，两组均给予贝拉克坦（4 ml/kg）作为外源性表面活性剂。Clinicaltrials.gov：NCT02611284。
在侵入性较小的表面活性剂给药组中，所有患者均成功给予贝拉克坦。侵入性较小的表面活性剂给药组中有13例患者（43.3%）在出生后前三天需要有创机械通气超过1小时，而对照组为22例（73%）（p<0.036）。两组婴儿中需要有创机械通气超过48小时的比例相似（分别为46%和40%）。其他结局无差异。
使用专门设计的插管采用侵入性较小的表面活性剂给药技术给予贝拉克坦（4 ml/kg）是可行的。此外，与插管、表面活性剂给药和早期拔管的策略相比，该方法可显著减少早期有创机械通气的暴露。
