Outcome of Extremely Preterm Infants Who Received Systemic Postnatal Corticosteroid for Bronchopulmonary Dysplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Composite primary outcome combining: - Respiratory evolution at 24 months corrected age - Neurodevelopmental evolution at 24 months corrected age - Growth evolution at 24 months corrected age
研究概览
简要总结
Bronchopulmonary dysplasia is a complication of prematurity. Postnatal corticosteroid is used to treat the inflammatory part of this pathology, in particular to wean premature infants from the ventilator at the end of the first month of life. However, this therapy remains controversial because it may induce suboptimal neurocognitive development. Parents of infants who receive postnatal corticosteroid should be provided with information about the risks. The objective of our work was to evaluate the respiratory, neurodevelopmental and growth outcomes at 24 months corrected age of extremely preterm infants who received postnatal corticosteroid.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Extremely preterm infants less than 29 weeks' gestation
- •Infants hospitalized for at least the first 30 days of life in the neonatology department of the Croix-Rousse Hospital in Lyon
- •Infants born between January 1, 2013 and December 31, 2016
排除标准
- •Infants with a congenital heart, lung or brain malformation
- •Infants with a neuromuscular disease
- •Infants with a genetic disorder
- •Infants who died before the age of 24 months corrected age
- •Infants lost to follow-up or with incomplete data at 24 months corrected age
结局指标
主要结局
Composite primary outcome combining: - Respiratory evolution at 24 months corrected age - Neurodevelopmental evolution at 24 months corrected age - Growth evolution at 24 months corrected age
时间窗: at 24 months corrected age
* Respiratory evolution at 24 months corrected age: asthma, inhaled corticosteroid therapy, respiratory events, hospitalizations for respiratory events. * Neurodevelopmental evolution at 24 months corrected age: developmental quotient of the revised Brunet Lézine scale, visual and auditory anomalies, cerebral palsy. * Growth evolution at 24 months corrected age: weight, height and head circumference at 24 months.
次要结局
未报告次要终点