NCT06925360招募中2 期
The Efficacy of Intravenous Immunoglobulin for the Treatment of Bronchopulmonary Dysplasia
International Peace Maternity and Child Health Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年4月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Survival without bronchopulmonary dysplasia at 36 weeks of postmenstrual age
研究概览
简要总结
It is intended to examine the efficacy and safety of intravenous immunoglobulin(IVIG) for the bronchopulmonary dysplasia in preterms. 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
- — 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age between 25 weeks and 29 weeks + 6 days
- •Admission within 24 hours after birth.
- •Clinical symptoms and chest X-ray results show a highly suspicion of BPD （Clinical symptoms and chest X-ray changes of BPD）.Clinical symptoms develop in several days or weeks after birth, including respiratory symptoms and signs such as shortness of breath, cyanosis or pulmonary rales, intermittent hypoxic attacks, and chronic oxygen dependence (increased oxygen concentration and assisted ventilation) .One of the following signs present in chest X-ray: lung texture thickening or ground glass opacity in early stage, diffuse lung texture blurred, lung hyperinflation, shadow of linear density increased, and shadow of triangular density increased under the pleura.
- •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
Experimental
干预措施: intravenous immunoglobulin (Drug)
结局指标
主要结局
Survival without bronchopulmonary dysplasia at 36 weeks of postmenstrual age
时间窗: 36 weeks of postmenstrual age
For this trial, bronchopulmonary dysplasia was defined as an infant ≤32 weeks' gestational age with persistent radiographic findings of parenchymal lung disease who requires respiratory support at 36 weeks of postmenstrual age for ≥3 days to maintain arterial oxygen saturation 90%-95% .
次要结局
- duration of O2 supplementation(until first discharge home or 36 weeks PMA)
- Time to improvement in pulmonary imaging(until first discharge home or 36 weeks PMA)
- Time to improvement in lung ultrasound imaging(until first discharge home or 36 weeks PMA)
- Preterm birth complications(until first discharge home or 36 weeks PMA)
- duration of mechanical ventilation(until first discharge home or 36 weeks PMA)
- Neurodevelopmental assessment(Corrected age/ chronological age of 6 months, 1 year, and 2 years.)
- Pulmonary function testing(Corrected age/ chronological age of 6 months, 1 year, and 2 years)
- Vision screening(Corrected age/ chronological age of 6 months, 1 year, and 2 years)
- Bone density measurement(Corrected age/ chronological age of 6 months, 1 year, and 2 years)
- Blood routine tests(Corrected age/ chronological age of 6 months, 1 year, and 2 years)
- Rehabilitation evaluation(Corrected age/ chronological age of 6 months and 1 year)
- 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)
研究者
研究点 (2)
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