An Open Label, Multicenter, Phase 2, Pilot Evaluation of SURFAXIN®(Lucinactant) Delivered as an Aerosol Via Nasal Continuous Positive Airway Pressure (nCPAP) in the Prevention of Respiratory Distress Syndrome in Premature Infants
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Number of Participants With Respiratory Distress Syndrome
研究概览
简要总结
To evaluate the feasibility, safety and tolerability of aerosolized lucinactant delivered by nasal continuous positive airway pressure (nCPAP) for the prevention of respiratory distress syndrome (RDS) in premature infants.
详细描述
Use of a device in the early treatment of RDS that permits the effective aerosolization of an exogenous surfactant that also allows for the simultaneous delivery of continuous positive airway pressure would permit the delivery of surfactant to the distal airways without intubation. This approach could reduce the frequency of severity of the adverse events relative to endotracheal intubation and surfactant administration via bolus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Minutes 至 30 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age 28-32 completed weeks, inclusive
- •Placement of arterial line
- •Successful initiation of nCPAP
- •Informed Consent
排除标准
- •Heart rate that cannot be stabilized >100 bpm within 5 minutes of birth
- •Five (5) minute Apgar score ≤ 3
- •Major congenital malformation(s) diagnosed antenatally or noted immediately after birth
- •Other disease(s) or conditions potentially interfering with cardiopulmonary function
- •Mother with prolonged rupture of membranes > 2 weeks
- •Known or suspected chromosomal abnormality
- •Need for chest compressions or administration of epinephrine, bicarbonate, or fluid boluses in the delivery room
- •Need for mechanical ventilation within 30 minutes of birth
研究组 & 干预措施
Regimen 1
干预措施: Aerosolized lucinactant (Drug)
Regimen 2
干预措施: Aerosolized lucinactant (Drug)
结局指标
主要结局
Number of Participants With Respiratory Distress Syndrome
时间窗: 24 hours
次要结局
- Area Under the Curve (AUC) for Fraction of Inspired Oxygen (FiO₂)(0.5, 1, 2, 4, 6, 12, 18, 24, 36, 48, 60, 72 hours)
- Arterial Alveolar (a/A) O₂Ratio(72 hours)
- Time to Meet Failure Criteria(Through 28 days)
- Number of Participants With Bronchopulmonary Dysplasia (BPD)(28 days)
- Number of Participants Alive and Without BPD(28 days)
- Number of Participants With Intraventricular Hemorrhage (IVH)/Periventricular Leukomalacia (PVL)(28 days)
- Number of Participants With Patent Ductus Arteriosus (PDA)(28 days)
- Number of Participants With Necrotizing Enterocolitis (NEC)(28 days)
- Number of Participants With Pulmonary Hemorrhage(28 days)
- Number of Participants With Acquired Sepsis(28 days)
- Incidence of Mortality(28 days)
- Number of Participants With Air Leak(28 days)