Duration of Surfactant Administration and Impact on Stabilisation of Vital Parameters in Very Preterm Neonates: 1 Minute Versus 5 Minutes - a Prospective Randomised-controlled Phase IV Trial - A Randomised Clinical Trial on Influence of Duration of Surfactant Administration on Stabilisation of Routine Monitoring Parameters and Cerebral Tissue Oxygen Saturation Monitoring in Preterm Neonates < 28 Weeks of Gestational Age
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Change in cerebral oxygenation (crSO₂) during and after LISA
研究概览
简要总结
Respiratory distress syndrome (RDS) is common in very preterm infants due to surfactant deficiency. Surfactant replacement therapy is lifesaving, and current guidelines recommend the less invasive surfactant administration (LISA) technique. However, the optimal duration of surfactant instillation during LISA has never been systematically evaluated. Rapid instillation may provoke transient hypoxia and bradycardia, while slower administration might improve physiological stability and cerebral oxygenation.
This randomised controlled trial investigates whether the duration of surfactant administration (1 minute versus 5 minutes) affects cerebral and systemic oxygen stability in extremely preterm neonates (< 28 weeks).
详细描述
The SurfStab I Trial is a single-centre, randomised, controlled, phase IV trial conducted at the Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Austria.
Infants born before 28 weeks of gestation and requiring surfactant therapy via the LISA technique will be randomised (1:1) to receive poractant alfa administered over either 1 minute or 5 minutes. The intervention duration represents two clinically accepted timeframes within current guideline recommendations.
Cerebral oxygenation will be monitored continuously using near-infrared spectroscopy (NIRS) from 5 minutes before to 3 hours after the procedure. The primary outcome is the maximal change in cerebral regional tissue oxygen saturation (crSO₂) from baseline (=5 minutes before starting the LISA procedure [insertion of the LISA catheter]) till 15 minutes after the LISA procedure (=removal of the LISA catheter). Secondary outcomes include changes in peripheral oxygen saturation (SpO₂), heart rate (HR), mean arterial blood pressure (MABP), frequency and duration of hypoxic or bradycardic episodes, and the need for repeated surfactant administration or invasive ventilation.
The total sample size is 76 infants (38 per arm). The study will provide evidence on whether slower surfactant administration improves physiological stability and cerebral oxygenation.
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 Months 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonate <28+0 weeks (gestational age up to 27 weeks and 6 days)
- •Indication of surfactant administration via the LISA method
- •Postnatal age < 72 hours
排除标准
- •Invasive ventilation, indication of INSURE procedure
- •Severe pulmonary or cardiac malformation affecting oxygenation or congenital cerebral malformation
- •Preexisiting diagnose of any IVH > grade 2 or PVH.
研究组 & 干预措施
1-Minute Administration ("1-min"-group)
Infants receive poractant alfa (Curosurf®) administered via the LISA technique over 1 minute.
干预措施: Poractant alfa (Curosurf®) - 1-minute administration (Drug)
5-Minute Administration ("5-min"-group)
Infants receive poractant alfa (Curosurf®) administered via the LISA technique over 5 minutes.
干预措施: Poractant alfa (Curosurf®) - 5-minute administration (Drug)
结局指标
主要结局
Change in cerebral oxygenation (crSO₂) during and after LISA
时间窗: From baseline (= 5min before insertion of the LISA catheter) till 15 minutes after removal of the thin catheter
The primary outcome measure will be the maximum change of crSO2 from baseline till the end of the primary window (=duration of LISA administration + 15 minutes after removal of the thin catheter). Mean values of crSO2 during the 5min before intervention started is defined as the baseline. crSO2 parameters with beginning five minute before surfactant administration till 15 minutes after extubating will be assessed every minute.
次要结局
- Change in arterial oxygen saturation (SpO₂) during and after LISA(From baseline (= 5min before insertion of the LISA catheter) till 15 minutes after removal of the thin catheter)
- Change in heart rate (HR) during and after LISA(From baseline (= 5min before insertion of the LISA catheter) till 15 minutes after removal of the thin catheter)
- Change in crSO2 up to three hours after LISA(Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure)
- Change in SpO2 up to three hours after LISA(Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure)
- Amount of supplemental oxygen(Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure)
- Need for invasive ventilation(Within 48 hours after first LISA procedure)
- Retinopathy of prematurity(At 40 weeks of corrected age)
- Change in HR up to three hours after LISA(Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure)
- Change in mean arterial blood pressure (MABP) up to three hours after LISA(Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure)
- Amount of bradycardia(Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure)
- Amount of cerebral hypoxia(Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure)
- Need for repeat surfactant administraiton(Within 48 hours after first LISA procedure)
- Amount of systemic hypoxia(Beginning of the surfactant administration (insertion of the thin catheter) till three hours after LISA procedure)
- Bronchopulmonary dysplasia (BPD)(At 36 weeks corrected gestational age)
- Intraventricular haemorrhage (IVH)(At 40 weeks of corrected age)
- Periventricular leukomalacia (PVL)(At 40 weeks of corrected age)
- Necrotizing enterocolitis (NEC)(At 40 weeks of corrected age)
- Mortality(At 40 weeks of corrected age)
研究者
Christina Wolfsberger, MD
Priv.Doz. DDr.
Medical University of Graz