Surfactant Replacement Guided by Early Lung Ultrasound Score (LUS) in Preterm Newborns < 33 Weeks With Respiratory Distress Syndrome in the Neonatal Intensive Care Unit of Saint-Etienne.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- administration time frame (min of life)
研究概览
简要总结
Lung immaturity is a major issue in neonatal unit.The surfactant administration improves the pulmonary prognosis in premature infants with hyaline membrane disease who escape continuous positive airway pressure (CPAP).
This surfactant had been administered at 5h25min of life in Saint Etienne from 2016 to 2019.
Studies suggest that the earlier the surfactant is administered, the more it can reduce the rate of bronchodysplasia and mortality. And some studies show a pulmonary ultrasound could help to administrate the surfactant earlier This is why a new faster strategy for diagnosing preterms needing surfactant will be usefulness and have been done in Saint-Etienne since 2021 thanks to a ultrasound score (LUS).
详细描述
This current study analyzes the impact of early Lungs Ultrasounds which use a semi-quantitative assessment : the Lung Ultrasound Score (LUS), in preterms <33 weeks on the time to surfactant administration.
The current hypothesis is that Lung Ultrasound can increase the number of preterms with surfactant replacement within the first 3 hours of life.
This is a prospective, comparative, observational trial between two different cohorts : the last 6 months of 2019 (without Score LUS) versus the first 6 months of 2021 (with Score LUS).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newborns <33 weeks old
- •born at the Saint Etienne University Hospital
- •respiratory distress syndrome
排除标准
- •chromosomal abnormality,
- •multi-polymalformations syndrome,
- •congenital pulmonary disease,
- •septic shock,
- •congenital lung infection,
- •meconium inhalation,
- •pneumothorax
- •conditions requiring surgery in the first week of life.
研究组 & 干预措施
Surfactant administration using score LUS
It is a prospective cohort : preterm newborns from january 2021 to juin 2020 needed a surfactant administration.
The surfactant is administrated if FiO2 >30% OR if score LUS >8/18 among the literature
干预措施: Surfactant administration since 2021 (Drug)
Surfactant administration without using score LUS
It is a retrospective cohort : preterm newborns from august 2019 to december 2019 needed a surfactant administration.
The surfactant was administrated only if the fraction of inspired oxygen (FiO2) >30% among the Guidelines of 2019
干预措施: Surfactant administration until 2020 (Drug)
结局指标
主要结局
administration time frame (min of life)
时间窗: day 1
Time from birth to surfactant administration
次要结局
- FiO2 maximum(Week 1)
- Ventilation support(Week 4)
- delay from FiO2 maximum to FiO2 < 21%(Week 4)
- Ventilation time (day)(Week 4)
- Bronchodysplasia rate(Week 4)