Point of Care Lung Ultrasound in Preterm Infants With Respiratory Distress: A Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Assess predictive ability of lung ultrasound scores in infants at risk of developing bronchopulmonary dysplasia (BPD)
研究概览
简要总结
The goal of this observational study is to learn about the role of bedside lung ultrasound in infants born prematurely with breathing problems. The main question this study aims to answer is: Can bedside lung ultrasound performed in the first month of life predict the development of chronic lung disease in premature infants?
详细描述
This is a multicenter study including preterm infants born less than 32 weeks gestational age and with a diagnosis of respiratory distress syndrome (RDS). Our primary aim is to determine the ability of lung ultrasounds performed in the first month of life to predict the development of bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age.
Secondary aims will evaluate the association of lung ultrasound scores with the severity of hemodynamically significant patent ductus arteriosus (PDA) at time of diagnosis, as well as describe lung ultrasound changes pre and post-treatment with systemic steroid course.
Hypothesis
- LUS scores would have a predictive ability to identify extreme preterm infants at risk of BPD with AUC>0.8.
- Higher LUS scores would correlate with higher severity of hemodynamically significant PDA.
- LUS scores are expected to be lower after the course of systemic steroids and with lower scores are expected to predict successful extubation following the course of systemic steroids.
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
- 0 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born less than 32 weeks gestation and meet one or more of the below criteria A) Diagnosis of Respiratory Distress Syndrome B) Diagnosis of PDA C) Post-natal steroid treatment for the purpose of weaning off ventilation support
排除标准
- •Infants with critical congenital heart and lung conditions and those with genetic anomalies.
结局指标
主要结局
Assess predictive ability of lung ultrasound scores in infants at risk of developing bronchopulmonary dysplasia (BPD)
时间窗: The lung ultrasounds will be performed on day of life 7, 14, 21 and 28 and diagnosis of BPD would be per standard criteria.
The primary outcome is to assess accuracy measures including specificity, sensitivity and area under ROC of lung ultrasound cut offs for predicting BPD.
次要结局
- Association between lung ultrasound scores and severity of patent ductus arteriosus.(The lung ultrasound would be performed around the time of echocardiographic diagnosis of patent ductus arteriosus and severity determined by standard criteria.)
- Comparison of lung ultrasound scores pre and post systemic steroid course administration(The lung ultrasound would be performed prior to steroid administration, 24 hours, 72 hours, 7 days, 10 days and 17 days after the first dose of 10 day course of systemic steroid administration.)
研究者
Hemananda Muniraman
Staff Physician
Phoenix Children's Hospital