Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization (ROMPER): A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Emergency room visits and high-acuity rehospitalizations.
研究概览
简要总结
This randomized clinical trial will determine the efficacy of remote patient monitoring using an Owlet OSS 3.0 pulse oximeter for the reduction of emergency room visits and high-acuity rehospitalizations among high-risk infants after NICU discharge.
详细描述
To determine if among infants being discharged from the neonatal intensive care unit (NICU) without a cardiorespiratory monitor or respiratory support, remote patient monitoring using an Owlet OSS 3.0 pulse oximeter (Owlet, Lehi, UT) decreases emergency room visits and high-acuity rehospitalizations after discharge compared with routine care.
Infants being discharged from the neonatal intensive care unit (NICU) without a cardiorespiratory monitor or respiratory support are eligible for inclusion.
The Investigators will provide remote patient monitoring using an Owlet OSS 3.0 pulse oximeter to infants in the intervention group for a 6 month period. The Investigators will collect monthly outcome measures from caregivers of all infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 22 Weeks 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants being discharged from the NICU
- •Off all respiratory support (oxygen, CPAP, ventilator) before discharge home
- •Gestational age ≥ 22 0/7 weeks' gestation at birth
- •Parents/legal guardians have provided consent for enrollment
排除标准
- •a major malformation, a neuromuscular condition that affects respiration or causes apnea, complex congenital heart disease and hemodynamically significant shunts, or terminal illness or decision to withhold or limit support.
- •Infants being discharged from the neonatal intensive care unit (NICU) with a cardiorespiratory monitor or respiratory support are not eligible for inclusion.
结局指标
主要结局
Emergency room visits and high-acuity rehospitalizations.
时间窗: 6 months
Number of emergency room visits and high-acuity rehospitalizations.
次要结局
- Number of participants with serious outcome events(6 months)
- High-acuity rehospitalizations(6 months)
- Apparent life-threatening event (ALTE/ Brief resolved unexplained event (BRUE)(6 months)
- Caregiver anxiety score.(6 months)
- All-cause mortality.(6 months)
- Other rehospitalizations(6 months)
- Safe-sleep practice adherence(6 months)
- Caregiver sleep disturbance.(6 months)
- Sick visits(6 months)
- Healthcare utilization(6 months)
- Emergency room visits(6 months)
研究者
Colm Travers
Assistant Professor
University of Alabama at Birmingham