Randomized Control Trial: Nasal CPAP vs. NIPPV in Preterm Infants With Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Treatment failure
研究概览
简要总结
Primary objective: to evaluate safety and efficacy of two different non-invasive respiratory support modalities in preterm neonatal patients with respiratory distress syndrome.
Secondary objective is to compare different respiratory support mode performance in different gestational age groups.
Primary endpoint is treatment failure.
With this study, the following hypotheses will be tested:
Hypothesis 1: NIPPV has a lower failure rate compared to CPAP mode. Hypothesis 2: NIPPV complication rate is non-superior compared to CPAP.
详细描述
Treatment failure is defined as any of the following:
- FiO2>0.6 to maintain SpO2>88%
- Respiratory acidosis (pH<7.2, pCO2>65 mmHg)
- recurrent apnea (>4 episodes/h) or apnea requiring bag and mask ventilation
- Silverman Andersen respiratory severity score (SAS score) ≥6 and does not improve by > 20% within 4-8 hours
Secondary endpoints:
- Mortality rate
- Intubation rate
- Late onset sepsis (LOS) rate
- Treatment duration
- Complication rates:
Pneumothorax rate Bronchopulmonary dysplasia (BPD) Necrotizing enterocolitis (NEC) Persisting ductus arteriosus (PDA) Intraventricular hemorrhage (IVH) Retinopathy of prematurity (ROP)
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
- None
入排标准
- 年龄范围
- 0 Minutes 至 44 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age (GA) between 22+0 and 34+6 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings).
- •Need of respiratory support (deemed by a clinician).
排除标准
- •Major congenital anomalies
- •Cardiovascular instability
- •Consent refused or not provided
结局指标
主要结局
Treatment failure
时间窗: 7 days
Need of intubation
次要结局
- Secondary outcomes(44 weeks corrected gestational age)
研究者
Arunas Liubsys
Associate professor
Vilnius University