Spectroscopic-chemometric Determination of Lecithin-sphingomyelin Ratio in Gastric Aspirates and Secretion From Hypopharynx at Birth, in Relation to Development of RDS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- RDS
研究概览
简要总结
The overall objective is to identify quickly after birth the preterm infants who will develop respiratory distress syndrome (RDS) for the purpose of treating them as early as possible with surfactant, to reduce, and if possible, to avoid sequelae, including long-term oxygen treatment.
We have therefore developed a quick test, which we believe will be ideal for this type of diagnostics, and will now test the method in a preclinical trial.
详细描述
In at least 135 preterm infants with gestational age 24-32 weeks we will collect gastric aspirate and hypopharyngeal secretion. The infants are stratified into three groups: gestational age 24-25 weeks, 26-29 weeks and 30-31 weeks.
The aspirates will be frozen at -20 centigrade and lecithin-sphingomyelin ratio (L/S) will be analysed retrospectively using Fourier Transform Infrared Spectroscopy.
The infants will be monitored for the first five days with regard to possible development of RDS.
Clinical and biochemical data will be compared retrospectively.
There a no intervention procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Minute 至 30 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with gestational ages of 24 (24+0) to 32 (31+6) weeks.
- •Age < ½ hour
排除标准
- •Lack of informed consent
- •lack of aspirate
结局指标
主要结局
RDS
时间窗: 5 days
次要结局
未报告次要终点
研究者
Henrik Axel Verder
Professor DMSc
Holbaek Sygehus