The Short-term and Long-term Effects of IVIG for Bronchopulmonary Dysplasia in Preterm Infant Born at 28 Weeks and Below
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- rate of BPD and severity classification at postmenstrual age (PMA) 36 weeks
研究概览
简要总结
It is intended to examine the short-term and long-term efficacy and safety of intravenous immunoglobulin(IVIG) for the bronchopulmonary dysplasia in preterms born at 28 weeks and below. Participants will received continuous infusion IVIG 1 g/kg/day for the first 2 days, 0.5 g/kg/day for next 3 days (total does 3.5 g/kg), repeatable if necessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age ≤ 28 weeks + 6 days
- •Admission within 24 hours after birth.
- •Clinical presentation and chest X radiograph changes of BPD
- •Clinical presentation: The respiratory symptoms and signs developed within several days or weeks after birth, such as shortness of breath, cyanosis or pulmonary rales, intermittent hypoxic attacks, and chronic oxygen dependence that requires invasive or non-invasive respiratory supports or oxygen inhalation to maintain blood oxygen saturation.
- •Chest X radiograph changes: The bilateral increased bronchovascular markings or ground-glass opacity and bilateral diffuse increased density, after the possible cause of other diseases such as infection and heart disease have been ruled out.
- •A normal full-term newborn without a history of severe lung diseases, birth asphyxia, hypoxic-ischemic encephalopathy or other conditions that may affect the development of the respiratory, nervous and other systems.
排除标准
- •Major congenital anomalies(e.g., congenital heart disease, congenital craniocerebral deformity, congenital structural abnormality of respiratory system, congenital hereditary metabolic disease)
- •Chromosomal defects (e.g., trisomy 13, 18, 21)
- •Severe intracranial hemorrhage
- •Multiple organ failure
- •With severe lung infections
- •Other circumstances that the investigator determines are not suitable for participation in this study
研究组 & 干预措施
IVIG
Drug: intravenous immunoglobulin
1 g/kg/day for the first 2 days, 0.5 g/kg/day for next 3 days (total does 3.5 g/kg), repeatable if necessary.
干预措施: intravenous immunoglobulin (Drug)
结局指标
主要结局
rate of BPD and severity classification at postmenstrual age (PMA) 36 weeks
时间窗: 36 weeks of postmenstrual age
Diagnostic Criteria for BPD: The 2018 National Institute of Child Health and Human Development (NICHD) diagnostic criteria will be applied, defining BPD in preterm infants born at \<32 weeks GA as the presence of radiographically confirmed persistent parenchymal lung disease with a requirement for supplemental oxygen support (for ≥3 consecutive days) at PMA 36 weeks to maintain arterial oxygen saturation in the range of 90-95%.
Diagnosis of bronchopulmonary dysplasia and severity of the condition at 36 weeks of PMA
时间窗: 36 weeks of postmenstrual age
According to the diagnosis criteria published by National Institute of Child Health and Human Development in 2018, a premature infant (\<32 weeks'gestational age) with BPD has persistent parenchymal lung disease, radiographic confirmation of parenchymal lung disease, and at 36 weeks PMA requires 1 of the following FiO2 ranges/oxygen levels/O2 concentrations for ≥3 consecutive days to maintain arterial oxygen saturation in the 90%-95% range. (We have rephrased the title and description to better recapitulate the original intent of the IRB-approved protocol)
次要结局
- duration of respiratory support(until first discharge home or 36 weeks PMA)
- Preterm birth complications(until first discharge home or 36 weeks PMA)
- Pulmonary function testing(Corrected age/ chronological age of 6 months, 1 year, and 2 years)
- Weight(Corrected age/ chronological age of 6 months, 1 year, and 2 years)
- Length(Corrected age/ chronological age of 6 months, 1 year, and 2 years)
- Head circumference(Corrected age/ chronological age of 6 months, 1 year, and 2 years)
- Neurodevelopmental assessment(Corrected age/ chronological age of 6 months, 1 year, and 2 years)
- Tidal Breathing Flow-Volume Curve Parameters(Corrected age/ chronological age of 6 months, 1 year, and 2 years)
- Composite Clinical Assessment of Pulmonary Function Status(Corrected age/ chronological age of 6 months, 1 year, and 2 years)