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临床试验/NCT04618627
NCT04618627Unknown不适用

Role of Lung Ultrasonography in Prediction of the Seveity and the Need for Surfactant Administration in Neonates With Respiratory Distress Syndrome

Assiut University0 个研究点目标入组 100 人开始时间: 2020年11月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Sensitivity and specificity lung ultrasound examination in identifying the severity and need for surfactant administration in neonates with RDS

研究概览

简要总结

We aim to identify the diagnostic role of a lung ultrasonography (LUS) score to predict the severity and the need for surfactant therapy in newborns with respiratory distress syndrome (RDS), and to compare it with a chest X-ray score.

详细描述

Respiratory distress syndrome (RDS) is a common problem in preterm infants. This condition is caused by deficiency of pulmonary surfactant in an immature lung and is related to morbidity and mortality in preterm infants. The incidence of RDS increases with the decreasing of gestational age (GA). The National Institute of Child Health and Human Development Neonatal Research Network reports a 93 percent incidence of RDS in a cohort of extremely preterm infants (GA 28 weeks or below)1. Although the risk is lower, RDS occurs even in a significant number of late preterm infants2. Diagnosis of RDS is based on clinical manifestations, arterial blood gas and chest X-ray findings. Chest X-ray is considered a first-line imaging test for diagnosis of RDS2. Chest X-ray findings, however, are not related to the respiratory prognosis3 .

Recently, lung ultrasonography (LUS) has been used in critically ill patient and it has become an important tool for neonatologists4. Specific LUS patterns have been described for typical neonatal respiratory conditions such as RDS5, transient tachypnea of the newborn (TTN)6, meconium aspiration syndrome (MAS)7, and pneumothorax8,9.As reported in The Consensus Conference on lung ultrasound, both LUS and chest X-ray are accurate in the diagnosis of RDS and TTN in neonates10.

Surfactant replacement therapy is crucial in the management of RDS. Recent guidelines recommend to treat affected babies with early nasal continuous positive airway pressure (nCPAP) and early selective surfactant administration10. The European Association of Perinatal Medicine and the American Academy of Pediatrics advise surfactant administration when oxygen requirement increases despite early nCPAP treatment11,12. Some studies have recently highlighted the usefulness of LUS in predicting neonatal intensive care unit admission or the need for mechanical ventilation13,14 or nCPAP failure15. Many scores based on LUS findings have proved their reliability in adult critical care16,17. In the neonatal field few studies presented chest X-ray derived scores18 or directly compared LUS with chest ray. There are no data, to our knowledge, that compare the accuracy of LUS with chest X-ray in predicting the need for surfactant administration in infants with RDS18-20.

Basically, each lung was divided into 3 areas (upper anterior, lower anterior, and lateral) and examined using a linear microprobe through both transverse and longitudinal scans. For each lung area, a 0- to 3-point score was given (total score ranging from 0-18). The LUS score encompassed signs typical of TTN and RDS21-22 . and described the total spectrum of possible conditions (a normal aerated lung, an interstitial pattern, an alveolar pattern, and consolidation). In details, the LUS score was assigned as follows:0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B pattern (defined as the presence of crowded and coalescent B lines with or without consolidations limited to the subpleural space); and 3, extended consolidations. A-lines represent reflection of pleura due to ultrasound diffusing through an airfilled lung; B-lines are due to fluid filling the interstitium (and the alveolar space if they become confluent)23,24.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
1 Hour 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • • Gestational age < 28 weeks.
  • Birth weight <1000 grams.
  • Newborns diagnosed only with RDS clinically and by chest X-Ray findings

排除标准

  • • Gestational age ≤ 28 weeks.
  • Birth weight ≤ 1000 grams.
  • Newborns with congenital anomalies.

结局指标

主要结局

Sensitivity and specificity lung ultrasound examination in identifying the severity and need for surfactant administration in neonates with RDS

时间窗: baseline

Sensitivity and specificity lung ultrasound examination in identifying the severity and need for surfactant administration in neonates with RDS

次要结局

  • Compare point-of-care lung ultrasound with chest x ray in the rate of detection of RDS in neonates.(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Elyan Ahmed

doctor

Assiut University

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