Comparison of bovine vs porcine surfactants by less invasive surfactant administration technique (LISA) for preterm infants ≤ 30 weeks with respiratory distress syndrome (RDS): a randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Requirement of intubation and mechanical ventilation within 72hours after birth post surfactant administration due to persistent respiratory distress with high FIO2 requirement (more than 40% ) on nasal CPAP (CPAP failure)
研究概览
简要总结
Respiratory distress syndrome (RDS) is the main cause of respiratory failure in preterm infants and its incidence differs depending on gestational age and birth weight. The best approach to treat RDS is the administration of delivery room CPAP followed by early selective surfactant administration for infants with worsening oxygenation and increasing work of breathing. European and American guidelines advise in favor of this strategy, which reduces mortality and bronchopulmonary dysplasia. Commonly available and widely used surfactants in India are Survanta/Beractant (bovine minced lung extract), Neosurf/BLES (bovine lung lavage surfactant), and Curosurf/Poractant alfa (porcine minced lung extract). A comparison of animal derived surfactants proved porcine surfactants to be superior over bovine surfactants in terms of efficacy and safety (Tridente et al 2019 systematic review). But this effect has not been well established with the current preferred method of surfactant administration i.e. LISA (less invasive surfactant administration) using a thin stiff catheter. All the previous studies where the LISA method was studied used porcine surfactant (poractant alfa/curosurf) for surfactant administration and bovine surfactants were not studied with this method. A recent study by Zamal et al has shown equivocal results with beractant when compared with poractant alfa by the LISA method and adverse events were not different between the two groups. However, the study concluded with Beractant to be a better option in LMIC in terms of cost. Surfactant administration through LISA has adverse effects of surfactant reflux which is expected to be higher with bovine surfactants which are of high volume (survanta 4ml/kg , neosurf 5ml/kg) compared to porcine surfactant (curosurf 2.5 ml/kg). Cost associated is more with porcine surfactant compared to bovine surfactants. If more data is available with bovine surfactants with this new method, it would be practical to use bovine surfactants in LMICs where cost also plays an important role. So, we have taken up this study to compare efficacy & safety of bovine surfactants vs porcine surfactant by LISA method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 3.00 Month(s)(—)
- 性别
- All
入选标准
- •Infants born at 26 0/7 to 30 0/7 weeks of gestation with features suggestive of RDS on nasal CPAP (with Fio2 requirement more than 30%) within 6 hours after birth, as decided by the treating physician will be included in the study.
排除标准
- •Infants who have life-threatening congenital anomalies or were considered non-viable Infants with severe hemodynamic instability, poor respiratory efforts Infants with Fio2 requirement less than 30% Infants who require early intubation and ventilation at birth Infants who were born after prolonged premature rupture of membranes (14 days prior to delivery).
- •Infants who have birth asphyxia (Apgar score of less than 7 at minute 5, umbilical cord pH less than 7, base excess (BE) more than -16) Infants who have anomalies of the upper or lower airway or mandible precluding use of nasal CPAP.
结局指标
主要结局
Requirement of intubation and mechanical ventilation within 72hours after birth post surfactant administration due to persistent respiratory distress with high FIO2 requirement (more than 40% ) on nasal CPAP (CPAP failure)
时间窗: Birth to 72 hours of life
次要结局
- Severe adverse events during the LISA procedure defined as prolonged apnea more than 20 seconds with desaturation (SpO2 less than or equal to 80%) and/or bradycardia (HR less than 80 beats/min) requiring up to bag & mask ventilation or escalation to NIPPV support.(Transient adverse events during the LISA procedure like desaturation and/or bradycardia not compromising the baby and picking up to normal within few seconds)
- Intubation within 7 days of life(Neonatal mortality within 28 days of life)
- Patent ductus arteriosus requiring treatment (hs-PDA)(Culture confirmed bacterial / fungal sepsis)
研究者
Dr Meena Kadiyala
Chettinad Hospital and Research Institute
