Comparison of Two Fraction Oxygen Inspired (FiO2) Thresholds for the Surfactant Administration in Preterm Infants With Respiratory Disease Syndrome: a Single-center Randomized Phase IV Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Respiratory pulmonary function
研究概览
简要总结
The aim of this study will be to assess the better fraction inspired oxygen (FiO2) threshold for the surfactant treatment in preterm infants with respiratory distress syndrome (RDS) randomized to receive exogenous surfactant at 25% or 35% of FiO2 threshold. The pulmonary gas-exchanges will be evaluated by oxygen saturation (SpO2) to FiO2 ratio (SFR) and will be used to define the better FiO2 threshold for the surfactant treatment.
详细描述
Exogenous surfactant therapy is an effective treatment of neonatal respiratory distress syndrome (RDS) and has been associated with reduced severity of respiratory distress and mortality. The 2019 European guidelines for neonatal RDS treatment suggest as the threshold of inspired oxygen (FiO2) for the surfactant treatment at 30% for all gestational age, but there are no randomized studies that confirm this indication. Some observational studies reported that a relevant number of patients who are not routinely treated with surfactant had respiratory complications, thus they received exogenous surfactant. To date, the optimal FiO2 threshold for surfactant administration remains unclear.
In this single-center, randomized, phase 4 trial, preterm infants (gestational age<32 weeks) with RDS will be randomized to receive exogenous surfactant at 25% or 35% of FiO2 threshold. According to the unit policy, the exogenous surfactant will be administered by an endotracheal tube in intubated infants, or by Intubation-Surfactant-Extubation (InSurE) / Less Invasive Surfactant Administration (LISA) methods in infants who will not remain intubated. The method used for the surfactant administration will be at the discretion of the caring physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be masked.
入排标准
- 年龄范围
- 24 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age less than 32 weeks;
- •diagnosis of respiratory distress (RDS);
- •need for ventilatory support;
- •written informed consent.
排除标准
- •congenital malformations;
- •genetic disorders;
- •perinatal asphyxia.
- •neonatal pneumonia or wet lung or meconium aspiration syndrome at birth.
研究组 & 干预措施
Low FiO2 threshold
A fraction of inspired oxygen (FiO2) of 25% to have an oxygen saturation (SpO2) of 90-92%.
干预措施: Poractant Alfa 80 mg/mL Intratracheal Suspension (Drug)
Medium FiO2 threshold
A fraction of inspired oxygen (FiO2) of 35% to have an oxygen saturation (SpO2) of 90-92%.
干预措施: Poractant Alfa 80 mg/mL Intratracheal Suspension (Drug)
结局指标
主要结局
Respiratory pulmonary function
时间窗: At day 3 of life
The oxygen saturation (SpO2) to fraction of inspired oxygen (FiO2) ratio (SFR)
次要结局
- Endotracheal intubation(At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first)
- Respiratory severity-1(At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first)
- In-hospital death(From birth to 36 week of gestation or discharge if it occurred first)
- Respiratory Support-1(At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first)
- Oxygen therapy(At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first)
- Respiratory severity-2(At day 3, 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first)
- Long-term respiratory pulmonary function(At day 7 and 28 of life, and at 36 weeks of postmenstrual age or at the discharge if it occurs first, and 1 year of corrected age)
- Complications of prematurity(From birth to 36 weeks of postmenstrual age or discharge if it occurred first)
研究者
Virgilio Paolo Carnielli
Director of Neonatology
Ospedali Riuniti Ancona