Relationship Between Fungal Colonization and Severe Bronchopulmonary Dysplasia: Myth or Reality? Retrospective Study of Premature Infants Inferior to 29 Weeks of Gestation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Severe bronchopulmonary dysplasia in premature infants inferior to 29 weeks of gestation
研究概览
简要总结
The aim of this study is to determine if fungal colonization is associated to severe bronchopulmonary dysplasia in premature infants less than 29 weeks of gestation, and to determine if an association exists between fungal colonization and complications of prematurity and death.
详细描述
Fungal colonization is common in premature infants. Certain neonatal departments, routinely screen for fungal colonization by weekly cultures, while other departments perform fungal cultures solely in the presence of suggestive clinical or biological signs such as hyperleucocytosis, maternal vaginal candidiasis, sepsis and characteristic skin lesions. This neonatal colonization can progress to an invasive fungal infection leading to death and comorbidities. A relationship between fungal colonization and severe bronchopulmonary dysplasia is suspected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Day 至 29 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infants inferior to 29 weeks of gestation screened for fungal colonization,
- •Admitted in the neonatal department of Centre Hospitalier Sud Francilien,
- •Between January 1st 2018 and December 31st 2020,
- •Holders of parental authority informed of the study that are unopposed
排除标准
- •Premature infants over 29 weeks of gestation, or term infants,
- •Premature infants less than 29 weeks of gestation not screened for fungal colonization during their hospitalization,
- •Premature infants with significant congenital malformations or genetic abnormalities,
- •Premature infants inferior to 29 weeks of gestation deceased in delivery room.
结局指标
主要结局
Severe bronchopulmonary dysplasia in premature infants inferior to 29 weeks of gestation
时间窗: at 36 weeks corrected age
Need of nCPAP, NIPPV, or nasal cannula ≥3 L/min with more than 30% of fraction inspired in Oxygen.
次要结局
- Retinopathy of prematurity(Day 0)
- Death(Day 0)
- Necrotizing enterocolitis(Day 0)
- Intraventricular haemorrhage grade 3 or 44(Day 0)
- Invasive fungal infection(Day 0)