NCT06786039招募中不适用
Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Rate of Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) failure
研究概览
简要总结
This is a prospective observational study investigating the impact of NIV-NAVA on short-term clinical outcomes and long-term neurodevelopment in very preterm infants.
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
- 1 Hour 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born between 27 weeks 0 days to 31 weeks 6 days of gestation
- •Preterm infants who require respiratory support within the first 48 hours of life
排除标准
- •Preterm infants who die within the first 48 hours of life
- •Preterm infants who do not require any respiratory support within the first 48 hours of life.
- •Preterm infants with congenital anomalies affecting the lungs, heart, or other organs that could influence breathing
- •Infants whose parents do not consent to participate in the study
研究组 & 干预措施
NIV-NAVA application
Preterm infants born between 27 weeks 0 days to 31 weeks 6 days of gestation requiring respiratory support within 48 hours after birth
干预措施: Non-invasive NAVA (Procedure)
结局指标
主要结局
Rate of Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) failure
时间窗: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months
NIV-NAVA failure was defined as a participant requiring endotracheal intubation (except brief intubation for only surfactant administration)
次要结局
- Rate of bronchopulmonary dysplasia (BPD)(at 36 weeks of postmenstrual age)
- Duration of non-invasive ventilation(through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months)
- Incidence of periventricular leukomalacia (PVL)(through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months)
- Duration of invasive ventilation(through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months)
- Incidence of air leaks(through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months)
- Incidence of patent ductus arteriosus (PDA)(through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months)
- Time to achieve full enteral feeding(through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months)
- Incidence of intraventricular hemorrhage (IVH)(through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months)
- Incidence of retinopathy of prematurity (ROP)(through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months)
- Total brain volume (mL)(term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI)
- Intracranial volume (mL)(term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI)
- Relative sizes of volumes of particular regions of interest(term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI)
- Bayley Scales of Infant Development III - 2 yr(18-24 months of corrected age)
- Modified Checklist for Autism in Toddlers (M-CHAT)(18-24 months of corrected age)
- MacArthur-Bates Communication Development Inventory(18-24 months of corrected age)
- Bayley Scales of Infant Development III - 3 yr(33-39 months of age)
- Child Behavior Checklist (CBCL)(33-39 months of age)
研究者
Juyoung Lee
Professor
Korea University Anam Hospital
研究点 (4)
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