Efficacy and Safety of the Intratracheal Administration of Budesonide With Porcine Pulmonary Surfactant in Very Preterm Infants to Prevent Bronchopulmonary Dysplasia: Randomized Clinical Trial (BuS Trial)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Lung ultrasound score at 7 days of life.
研究概览
简要总结
This study is designed to determine whether intratracheal administration of budesonide combined with surfactant, as compared to surfactant alone, will modify ecographic (lung ultrasound score) and biological markers (IL-6 concentration in respiratory secretions) at 7 days of life in preterm infants ≤32 weeks of gestational age (GA).
详细描述
Bronchopulmonary dysplasia (BPD) is one of the main morbidities associated with extreme prematurity and, despite the improvement of respiratory care in the latest years, overall incidence is not decreasing. Etiology of BPD is multifactorial and local inflammation plays an important role in it, therfore, local anti-inflammatory drugs could be effective in preventing BPD.
Recent randomised trials have shown a lower incidence of BPD/death with the use of a combination of budesonide with surfactat compared to surfactant alone, and further clinical trials are currently ongoing.
This is a controlled phase IV, randomised, unicenter clinical trial designed to evaluate the effect of intratracheal administration of budesonide combined with surfactant, as compared to surfactant alone, in BPD in preterm infants ≤32 weeks of GA. Investigators will compare ecographic and biological markers, as well as respiratory outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
When eligibility of an infant is confirmed, consent will be obtained. Infants candidates to surfactant administration will be randomly assigned to either receive surfactant with budesonide, or surfactant alone, using a web-based randomisation system with an allocation ratio of 1:1.
Primary care provider in charge of the patient at the time of the enrolment will be responsible for the randomization, and for the preparation of the drug (surfactant alone, or surfactant with budesonide).
Participants will be masked.
入排标准
- 年龄范围
- — 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born equal or earlier than 32 weeks of gestational age admitted in the Neonatal Intensive Care Unit.
- •Parental consent signed.
- •Less than or equal to 48 hours postnatal age.
排除标准
- •Infants with known major congenital anomalies (eg. congenital upper airwayobstruction, congenital lung anomaly, severe pulmonary hypoplasia, hydrops,neuromuscular diseases, chromosomopaties)
- •Infants with poor prognosis and risk of imminent death
- •Infants who have received the first dose of surfactant before of the enrolment to the study.
研究组 & 干预措施
Standard treatment group
Infants randomised to the "standard treatment" arm will receive intratracheal surfactant as per usual clinical indications of respiratory distress syndrome in these preterm infants.
In that sense, and based in those clinical indications, we have developed a risk calculator for surfactant administration in preterm infants ≤32 weeks GA. We will use it to decide what patients will receive surfactant (calculator available on: https://1drv.ms/x/s!Arjkl83HIXSngP8TWh8O6oi6Ztdw3w?e=gNCMxP).
干预措施: Poractant Alfa Intratracheal Suspension [Curosurf] (Drug)
Interventional treatment group
Infants randomised to the "interventional treatment" arm will receive intratracheal surfactant mixed with budesonide. Indication of surfactant, as equal as for the "standard treatment" arm, will be decided using the calculator.
干预措施: Poractant Alfa Intratracheal Suspension [Curosurf] (Drug)
Interventional treatment group
Infants randomised to the "interventional treatment" arm will receive intratracheal surfactant mixed with budesonide. Indication of surfactant, as equal as for the "standard treatment" arm, will be decided using the calculator.
干预措施: Budesonide 0.5 MG/ML (Drug)
结局指标
主要结局
Lung ultrasound score at 7 days of life.
时间窗: 7 days of life
LUS will be performed with the patients in supine position and slightly lying on the side of the taken view. Each lung will be divided in five areas through longitudinal orientation and images will be taken using the linear probe (VF 13-5MHz).
IL-6 concentration in respiratory secretions at 7 days of life.
时间窗: 7 days of life
Nasopharyngeal aspirate (NPA) will be collected by standard procedure. IL-6 concentration will be determined by Human IL-6 Quantikine ELISA (R\&D Systems Inc., Minneapolis, MN, USA).
次要结局
- Lung ultrasound score at 28 days of life.(28 days of life)
- IL-6 concentration in respiratory secretions at 28 days of life.(28 days of life)
- Respiratory status and neurodevelopment(24 months of age.)
- Number of days of oxygen(7 and 28 days of age, 36 weeks of post-menstrual age.)
- Number of days of respiratory support(7 and 28 days of age, 36 weeks of post-menstrual age.)
- Mean airway pressure (MAP)(7 and 28 days of age, 36 weeks of post-menstrual age.)
- Incidence of bronchopulmonary dysplasia(36 weeks of post-menstrual age.)