Neonatologist-performed Lung Ultrasound During Immediate Transition After Birth to Predict the Need for Respiratory Support Persisting More Than 1 Hour - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Determination of the change in lung ultrasound score according to Rodriguez-Fanjul et al. 2020
研究概览
简要总结
The objective of this study is to evaluate the role of the neonatologist-performed lung ultrasound (NPLUS) during immediate transition after birth of late preterm and full-term neonates using the lung ultrasound score to predict the need of respiratory support persisting more than 1 hour after birth.
详细描述
Lung ultrasound is an emerging clinical tool to assess the lung in a dynamic way. Recently, the focus has been on establishing lung ultrasound in the neonatal intensive care unit (NICU) as a point-of care application.
Neonates born by a Caesarean section are particularly prone to have an altered adaption to extrauterine life. Especially in the first hours after birth, respiratory distress syndromes (RDS) may occur due to delayed lung fluid clearance after birth.
While acute RDS in the first hours after birth may be a self-limiting disorder and therefore a benign condition, it remains difficult to identify neonates in need for further respiratory support at the NICU. Admission to the NICU not only causes parental stress but also contributes to additional healthcare costs.
There is emerging evidence that NPLUS is a reliable tool to differentiate between the causes leading to RDS in neonates. Using a neonatologist performed lung ultrasound score for the early identification of neonates in need of respiratory support persisting more than 1 hour would be therefore highly advantageous.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 60 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Late preterm neonates (born between 34 0/7 and 36 6/7 weeks of gestation) and full-term neonates (born later than 36 6/7 weeks of gestation) delivered by Caesarean section
- •Presence of any sign of respiratory distress (defined as tachypnoea/ dyspnoea, grunting, flaring of the nostrils or chest retractions)
- •Written informed consent obtained from the parents prior to birth.
排除标准
- •Presence of cardiopulmonary malformations
- •Patients with pneumothorax diagnosed by neonatologist-performed lung ultrasound
结局指标
主要结局
Determination of the change in lung ultrasound score according to Rodriguez-Fanjul et al. 2020
时间窗: 60 minutes for all scans, 2-4 min per scan.
Score determined by neonatologist-performed lung ultrasound conducted at 5, 15, 30 and 60 minutes after birth. The lung ultrasound score will be calculated by performing bilateral longitudinal scans of the chest on the midclavicular, anterior, and posterior axillary line. For every scan a score is given ranging from 0 (for normal lung aeration) up to 3 (describing extended consolidations in the lung).
The need for respiratory support persisting more than 1 hour after birth
时间窗: 60 minutes
binary - yes/ no
Admission to the Neonatal Intensive Care Unit
时间窗: 60 minutes
binary - yes/ no
次要结局
- SpO2/FiO2(60 minutes)
- Length of respiratory support(60 minutes)
- Number of Participants with Presence of pregnancy risk factors(10 minutes)
- Routinely obtained capillary blood gas analysis of the newborn(60 minutes)
- Mode of respiratory support(60 minutes)
- Routinely obtained monitoring parameters- SpO2(60 minutes)
- pH of the umbilical artery(15 minutes)
- Routinely obtained monitoring parameters- heart rate(60 minutes)
- Routinely obtained monitoring parameters- cerebral oxygen saturation(60 minutes)
- APGAR score(10 minutes)
- Number of Participants with Prenatal corticosteroids(10 minutes)