HELIOX NCPAP

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 简介：呼吸窘迫综合征(RDS)是极低出生体重儿(ELBW)最常见的肺部病理改变。近年来，鼻腔持续正压通气(NCPAP)在治疗低出生体重儿合并RDS中的应用越来越多。早期使用NCPAP消除了插管和机械通气的需要，以及与其相关的并发症。在临床实践中，有相当数量的患有RDS的ELBW婴儿在出生后72小时内未能通过NCPAP治疗，需要进行抢救插管。先前使用氦氧(氦和氧的混合物)治疗RDS的研究已经显示出明显的治疗益处。最近有报道称，通过nCPAP设备(HX-nCPAP)输送的氦的使用。鉴于氦氧在RDS治疗中的成功经验，结合最近HX-nCPAP的出现，我们打算研究HX-nCPAP在减少患有RDS的ELBW婴儿早期nCPAP失败中的作用。 研究设计：比较传统nCPAP和HX-nCPAP的前瞻性、开放标签、随机对照试验。 方法：出生时小于或等于28周的自然呼吸极低出生体重(ELBW)婴儿，估计胎龄为RDS，并自出生起就接受NCPAP治疗，符合登记条件。志愿者婴儿将被随机分配到传统的NCPAP或HX-NCPAP。将在氦氧组和对照组之间比较主要和次要结果指标，以确定HX-nCPAP是否导致早期nCPAP失败和/或改善临床结果。 儿童权利中心的参与将包括协助研究协调、招募受试者、维护研究记录、创建数据库、数据录入和数据分析。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Introduction: Respiratory distress syndrome (RDS) is the most common pulmonary pathology in extremely low birth weight (ELBW) infants. In recent years there has been an increased use of nasal continuous positive airway pressure (nCPAP) in the management of ELBW infants with RDS. The use of early nCPAP eliminates the need for intubation and mechanical ventilation, and their associated morbidities. In clinical practice a significant number of ELBW infants with RDS fail nCPAP therapy within the first 72 hours of life and require rescue intubation. Prior studies using heliox (mixture of helium and oxygen) in the management of RDS have shown clear therapeutic benefits. The use of heliox delivered via a nCPAP device (Hx-nCPAP) has recently been reported. Given the prior success of heliox in the management of RDS combined with the recent advent of Hx-nCPAP we intend to investigate the utility of Hx-nCPAP in reducing early nCPAP failure in ELBW infants with RDS. Research Design: Prospective, open-label, randomized, control trial comparing conventional nCPAP to Hx-nCPAP. Methods: Spontaneously breathing ELBW infants born at less than or equal to 28 wks estimated gestational age with RDS and on nCPAP since birth will be eligible for enrollment. Volunteer infants will be randomly assigned to conventional nCPAP or Hx-nCPAP. Primary and secondary outcome measures will be compared between the heliox group and control group to determine if Hx-nCPAP results in fewer early nCPAP failures and/or improved clinical outcomes. CRC involvement will include assistance with study coordination, subject recruitment, maintenance of study records, database creation, data entry, and data analysis.