Leveraging Telemedicine to Reduce Disparities in Time to Initiation of Therapeutic Hypothermia in Rural Settings; a Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- MaineHealth
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Time to Initiation of Therapeutic Hypothermia
研究概览
简要总结
This pilot intervention trial will assess the feasibility of a live consultation between community hospital providers and tertiary care providers employing a novel teleconsult platform, Maine Neonatal Encephalopathy Teleconsult (Maine NET), on the time to initiation of therapeutic hypothermia (TH) for 35 infants born in community hospitals in Maine compared with matched historical controls. Community hospital providers and tertiary care center provider satisfaction with the Maine NET platform will also be assessed. The hypothesis is that immediately available expert assessment via a teleconsult platform will promote earlier implementation of TH and be associated with high levels of provider satisfaction.
详细描述
The study will recruit a total of 125 infants from the participating centers and anticipate that 35 of these subjects will be treated with therapeutic hypothermia and be utilized for the comparative analysis to historical controls. Not all infants recruited and provided a Maine NET consultation will be treated with TH and to have an adequate sample size to make statistical comparisons with historical controls we need to enroll more than 35 participants to ensure 35 have been treated with TH for the comparative analysis.
In a secondary qualitative study, clinicians who completed Maine NET consults through the above clinical trial were interviewed about their experience with the consult. This secondary study will recruit up to 20 clinicians who completed a consult in this clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants included in this study will be born at a community hospital, will be in either high or moderate risk, will be younger than 6 hours of age at the time of the consultation and the decision will have been made to treat with TH. High risk infants will be defined as an umbilical cord pH of less than or equal to 7.0 or 5 minute APGAR score of less than or equal to 5 or a need for resuscitation (including respiratory support or chest compressions) or an abnormal exam (which may include flaccid tone, poor suck reflex or poor response to stimulation) or seizures at less than 6 hours of life. Moderate risk infants will be defined as an umbilical cord pH of less than or equal to 7.2 but greater than 7.0 or 5 minute APGAR score of less than 7 but greater than 5 or a perinatal event (such as placental abruption, uterine rupture, cord prolapse, or fetal-maternal hemorrhage) or an abnormal exam (which may include a hyper-alert state).
排除标准
- •Infants older than 6 hours at the time Maine NET is requested and infants for whom TH is not an appropriate therapy (e.g. due to premature birth or moribund status) will be excluded.
结局指标
主要结局
Time to Initiation of Therapeutic Hypothermia
时间窗: First 6 hours of life
Time to initiation of therapeutic hypothermia
次要结局
未报告次要终点
研究者
Alexa Craig
Associate Professor of Pediatrics
MaineHealth