3D Imaging of Neonatal Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Deformation changes in nares of preterm infants that require ncpap
研究概览
简要总结
Facial scans of newborns will be performed before and after implementation of respiratory support devices such as nasal CPAP. 3D scanned images will be processed by Fisher & Paykel Healthcare Limited. Images will be analyzed for changes or distortion in nasal structure.
详细描述
Any newborns admitted to the neonatal intensive care unit at Sharp Mary Birch Hospital for Women and Newborns between 24-42 weeks CGA with parental informed consent are eligible. 3D scanned image will be obtained prior to implementation of nasal support devices and after nasal support devices. Fisher & Paykel Healthcare Limited will analyze the 3D images and observations will be made for changes in nasal structure or distortion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 24 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants between 24 and 42 weeks corrected gestational age (inclusive) born at Sharp Mary Birch NICU,
- •Signed informed consent form
排除标准
- •Nasally intubated infants
- •Infants with craniofacial abnormalities
结局指标
主要结局
Deformation changes in nares of preterm infants that require ncpap
时间窗: Up to 6 months
3D scans of infants face will be performed before implementation of NCPAP and a 3D scan will be performed after the NCPAP is discontinued and the images will be analyzed for changes in facial structures that might be due to NCPAP.
次要结局
未报告次要终点
研究者
Anup Katheria, M.D.
Director of Neonatal Research
Sharp HealthCare