Parent Perceptions of OptiPAP Junior
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Parent perception of different respiratory devices
研究概览
简要总结
To evaluate how different forms of respiratory support affect parent interaction, how parents feel about different methods of support, and how their child's current respiratory support level is perceived in the setting of long-term outcomes.
详细描述
The information gathered in this study is relevant to all NICU families of children who need respiratory support as the investigators will assess parent perceptions of different devices, namely the OptiPAP Junior, as well as aspects of respiratory support to share with the broader NICU community and change how NICU providers talk about these devices and lung outcomes with parents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born less than 31 weeks who have been stable for 72 hours on continuous positive pressure level (CPAP) of support via a standard interface.
- •Parents (females or males) must be greater than 18 years of age at the time of the interview after their infant has experienced both respiratory modalities.
排除标准
- •Infants will be excluded if they have suspected or confirmed abnormalities/trauma to the skull or airway involving any abnormal connection that may allow pressure to be transmitted to unintended anatomical structures or tissues.
研究组 & 干预措施
OptiPAP Junior
The OptiPAP Junior device (Fisher & Paykel) is an FDA cleared device interface for the provision of pressure-based respiratory support to be used in accordance with its approved labeling.
干预措施: Nasal CPAP interface: OptiPAP Junior (Device)
Flexitrunk
The Flexitrunk (Fisher & Paykel) is a predominant interface used in neonatal care units. Flexitrunk is an FDA cleared device interface for the provision of pressure-based respiratory support to be used in accordance with its approved labeling.
干预措施: Nasal CPAP interface: FlexiTrunk (Device)
结局指标
主要结局
Parent perception of different respiratory devices
时间窗: From baseline to study completion, an average of 3 months.
To assess parent perception of different respiratory devices, namely the OptiPAP Junior, in comparison to other modalities through semi-structured parent interviews.
次要结局
- Parent perception and recommendations on inpatient pulmonary support and outcome measurements(From baseline to study completion, an average of 3 months.)
研究者
Rebecca Dorner, MD, MHS
Principal Investigator
Sharp HealthCare