Premature Infant Exposure to Noise Generated by Respiratory Support
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Noise level
研究概览
简要总结
Infants in neonatal intensive care units are increasing exposed to non-invasive ventilatory support modes (nasal continuous positive airway pressure - NCPAP and high flow nasal cannula: >1 L/min flow - HFNC). While there have been small descriptive studies of noise exposure in infants on NCPAP, there have been no comparative trials done comparing noise exposure in infants undergoing both NCPAP and HFNC.
Objective: Using a cross-over model determine noise exposure levels in infants exposed to similar levels of respiratory support provided by NCPAP and HFNC.
详细描述
Infants born < 32 weeks, in an incubator, and > 7 days postnatal that were maintained on either on NCPAP or HFNC to maintain SaO2 in a range of 88 - 92 %. Study infants had decibel measurements obtained every 15 seconds for 30 minutes using a noise dosimeter (NoisePro DLX-1). The microphone for the dosimeter was suspended from the inside of the incubator such that it hung 1 foot above the infants nose and mouth. The exhalation port for NCPAP was placed outside of the incubator. Repeated measurement periods on the same mode of support were made within a 72 hour period. Each infant the acted as their own control and was switched within 7 days to the alternative respiratory support method that maintained similar SaO2 goals and repeat measurements were obtained. Comparisons of mean decibel levels during recording were compared using paired t-tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infant born < 32 weeks and 0 days post-conceptional age;
- •Seven or more days of age and not in acute respiratory distress;
- •Need for nasal continuous positive airway pressure or high-flow nasal cannula for ventilation or supplemental oxygen delivery;
- •In a neutral-thermal environment (i.e. isolette)
排除标准
- •Oro-facial congenital anomalies;
- •Congenital heart disease (except for patent ductus arteriosus and/or patent foramen ovale);
- •Unstable respiratory status as deemed by the attending physician
- •Patients under isolation for infectious disease
结局指标
主要结局
Noise level
时间窗: 6 days
Noise levels will be measured during a set time while infants are on Nasal CPAP and Nasal High flow cannula as standard of care
次要结局
未报告次要终点
研究者
Jonathan Swanson, MD
Prinicipal Investigator
University of Virginia