HELIOX NCPAP

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 前言：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。 近年来，鼻持续气道正压通气（nCPAP）在治疗伴有RDS的ELBW婴儿中的应用越来越多。早期nCPAP的使用消除了插管和机械通气的需要及其相关的发病率。在临床实践中，大量患有RDS的ELBW婴儿在出生后72小时内无法接受nCPAP治疗，需要进行抢救插管。以前的研究使用氦氧混合气（氦和氧的混合物）在RDS的管理已显示出明确的治疗效益。 最近已经报道了通过nCPAP装置（Hx-nCPAP）输送的氦氧混合气的使用。考虑到氦氧混合气在RDS治疗中的先前成功以及最近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失败方面的效用。 研究设计：比较传统nCPAP与Hx-nCPAP的前瞻性、开放标签、随机对照试验。 研究方法：出生时估计胎龄小于或等于28周且患有RDS且自出生起接受nCPAP的自主呼吸ELBW婴儿将有资格入组。志愿婴儿将被随机分配到传统nCPAP或Hx-nCPAP组。将在氦氧混合气组和对照组之间比较主要和次要结局指标，以确定Hx-nCPAP是否导致更少的早期nCPAP失败和/或改善临床结局。 CRC的参与将包括协助研究协调、受试者招募、研究记录维护、数据库创建、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.