InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS: A Single-dose, Double-blind, Random Allocation, Sham-control, Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 20
- 主要终点
- CPAP failure and or death
研究概览
简要总结
The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support.
详细描述
This single-dose, double-blind, random allocation, sham-control, clinical trial will recruit spontaneously breathing newborns with RDS stable on non-invasive nasal respiratory support. Enrolled clinical study subjects will be randomly allocated to receive respiratory air with Infasurf® (Intervention Arm) or respiratory air alone (Sham Control Arm) through the InfasurfAero™.
The objectives of this clinical study are to i) assess the effectiveness of a single dose of Infasurf administered through the InfasurfAero in preventing CPAP failure, and ii) assess the safety of Infasurf administered through the InfasurfAero.
Subjects will be enrolled at one of 10+ sites. 7 sites are currently recruited.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All study procedures will be performed behind a portable screen or curtain, or in a separate procedure room so that non-study personnel (including the primary care team) will be unaware of the subject's assigned study arm. Study personnel involved in the study procedure will not be masked. All other study personnel including the investigator and the outcomes accessor will be masked throughout the duration of the study.
The subject's family will remain blinded to treatment assignment throughout.
入排标准
- 年龄范围
- 29 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria include ALL of the following:
- •Written informed consent obtained by parent or legal representative prior to or after birth
- •Gestational age at birth ≥ 29 0/7 AND ≤ 35 6/7 weeks
- •Birthweight ≥ 1,000 AND ≤ 3,500 grams
- •Age ≥ 1 hour AND ≤ 6 hours
- •Clinical diagnosis of surfactant-deficient RDS, with EITHER i. a Silverman-Anderson Retraction Score ≥ 5 (in Room Air), OR ii. signs of respiratory distress (tachypnea, retractions, grunting) AND radiographic confirmation
- •Require CPAP
- •Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4
- •If subject is >346/7 weeks' gestation a chest radiograph is required
排除标准
- •Exclusion criteria are ANY of the following:
- •Surfactant administration prior to randomization
- •Mechanical ventilation prior to randomization
- •Major congenital anomaly (suspected or confirmed)
- •Abnormality of the airway (suspected or confirmed)
- •Respiratory distress presumed secondary to an etiology other than RDS (e.g., suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy)
- •Apgar score < 3 at 5 minutes of age
- •Umbilical cord gas pH <7.0 or BD > 10
- •Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
结局指标
主要结局
CPAP failure and or death
时间窗: Within 1st week of age
CPAP failure is defined as a respiratory severity score (RSS) (MAP x FiO2) \>2.5 on two consecutive assessments at least 30 minutes apart, or an RSS \> 2.4 and one or more of the following: (i) Silverman-Andersen respiratory severity score (https://www.thecalculator.co/health/Silverman-Score-Calculator-1125.html) of ≥ 5 despite respiratory support. (ii) Severe apnea (2 or more episodes per hour, or 1 or more episodes requiring manual positive pressure ventilation). (iii) Respiratory acidosis (pCO2 \> 65 with a pH \< 7.2 on blood gas). RSS will be the primary indicator of CPAP failure. However with the addition of the Silverman-Anderson scores, severe apnea and respiratory acidosis, CPAP failure may occur earlier than solely defined by RSS score.
次要结局
- Duration of MV(36 weeks PMA)
- Chronic lung disease and or death(36 weeks post menstrual age (PMA).)
- Incidence of MV(36 weeks PMA)
- Incidence of intubation(36 weeks PMA)
- Incidence of invasive surfactant replacement therapy(72 hours post birth)
- Duration of non-invasive support(36 weeks PMA)
- Duration of supplemental oxygen(36 weeks PMA)