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临床试验/NCT04785859
NCT04785859招募中不适用

Multiparametric Prediction of the Risk of Moderate-severe Bronchopulmonary Dysplasia in Neonates Born Before 30 Weeks of Gestation

Andaluz Health Service1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
240
试验地点
1
主要终点
multiparametric moderate-severe BPD prediction

研究概览

简要总结

INTRODUCTION: Current Neonatology has failed to reduce the incidence of moderate-severe bronchopulmonary dysplasia (BPD). Although multiple models for predicting the risk of dysplasia in preterm infants have been studied, none have been implemented in clinical practice.

OBJECTIVE: To calculate a mathematical model to predict moderate-severe bronchopulmonary dysplasia in newborns before 30 weeks of gestation based on pre and postnatal clinical variables, lung ultrasound images and detection of biomarkers in nasopharyngeal aspirate.

METHODOLOGY: Multicenter case-control study, in which 10 Spanish neonatal intensive care units (NICU) will participate. All participants will undergo a lung ultrasound in the first 24 hours, on the third day of life, at one week and two weeks of life, a nasopharyngeal aspirate at one week of life, and cardiac ultrasound at one week and two weeks of life. It is expected to include 240 patients in 29 months of study among all participating units: 200 for the calculation of the model, and 40 more for its subsequent validation. These will be divided between those with a diagnosis of moderate-severe BPD and those without, and the values of each of the variables described in the methodology section will be compared between the two groups. Those with a significant difference will be entered into a logistic regression model to calculate those that best predict the final diagnosis. With the results of the calculated model, a mobile application will be created with a risk of moderate-severe BPD calculator in this population, for its worldwide distribution.

详细描述

Type of study: case-control study. Study population: Neonates of less than 30 weeks´ gestation, born at any of the study centers, or transferred from other centers in the first 24 hours of life, during the study period. The participating hospitals will be: Puerta del Mar University Hospital in Cádiz, Basurto University Hospital in Bilbao, Álvaro Cunqueiro University Hospital in Vigo, Doctor Josep Trueta University Hospital in Girona, Clínic University Hospital in Barcelona, León University Hospital, Gregorio Marañón University Hospital in Madrid, German Trias i Pujol Hospital in Barcelona, Miguel Servet Hospital in Zaragoza and Val d'Hebron Hospital in Barcelona.

Study protocol: The following lung ultrasounds will be performed on the patients included in the study: first 24 hours of life, 3rd day of life (DOL) and 7th DOL. At one week of life detection of proteins in nasopharyngeal aspirates will be performed. During the first week of life, an echocardiography will be performed in all patients to evaluate the possibility of a patent ductus arteriosus and its hemodynamic significance.

In the first 20 patients who remain intubated at one week of life, tracheal aspirates will be obtained too, to compare protein determination

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 1 Day(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates of less than 30 weeks´ gestation, born at any of the study centers, or transferred from other centers in the first 24 hours of life, during the study period

排除标准

  • Neonates with severe chromosomal abnormalities, or severe congenital anomalies, infants who died prior to 36 weeks´ corrected age, as well as patients whose clinical condition prevents the performance of the study protocol ultrasounds.

结局指标

主要结局

multiparametric moderate-severe BPD prediction

时间窗: 7 days

• To assess if LUS and respiratory tract inflammatory parameters in the first week of life of preterm babies born before 30 weeks´ gestation, improves the predictive power of epidemiological and clinical variables for moderate-severe BPD.

次要结局

  • Diffusion of the models obtained(After 36 weeks' postmenstrual age)
  • respiratory variables prediction by LUS(7 days)

研究者

发起方
Andaluz Health Service
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Almudena Alonso Ojembarrena

Dr.

Andaluz Health Service

研究点 (1)

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