LUNG ULTRASOUND-GUIDED SURFACTANT THERAPY AND VIDEO LARYNGOSCOPY FOR THIN CATHETER INTUBATION IN PRETERM NEONATES OF LESS THAN 32 WEEKS GESTATION WITH RESPIRATORY DISTRESS AT BIRTH: A 2x2 FACTORIAL DESIGN CLINICAL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- 1. Composite outcome of BPD (as per Jensen et al criteria) or death(all cause, before discharge) at term equivalent age(40 weeks Post-Menstrual age)
研究概览
简要总结
This study intends to compare lung ultrasound guided surfactant administration with standard criteria guided surfactant administration for a 10 percent absolute reduction in the incidence of a composite outcome of death or BPD by 40 weeks PMA in preterm neonates of less than 32 weeks’ gestation with respiratory distress at or within 2 hours from birth and to compare video laryngoscopy (VL) assisted versus fibre optic direct laryngoscope (FODiL) assisted less invasive surfactant administration for improvement in procedural success rate by at least 10 percent in the same population of preterm neonates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 0.10 Day(s) 至 0.40 Day(s)（—）
- 性别
- All
入选标准
- •Preterm neonates with more than 25 and less than32 weeks of gestational age.
- •Respiratory distress since birth or onset within 2 hours from birth.
- •Require continuous positive airway pressure support of at least 5 cm H2O and FiO2 of more than 0.21 to maintain preductal pulse saturation in 91 to 95% target range.
排除标准
- •Major or life-threatening congenital anomalies.
- •Hemodynamic instability requiring vasopressors or inotropes or inhaled nitric oxide.
- •Requiring endotracheal intubation during resuscitation at birth or due to insufficient spontaneous respiratory efforts to initiate CPAP.
- •Pulmonary air leaks (pneumothorax, pneumomediastinum) before the administration of first dose of surfactant.
- •Refusal of consent by the parents.
结局指标
主要结局
1. Composite outcome of BPD (as per Jensen et al criteria) or death(all cause, before discharge) at term equivalent age(40 weeks Post-Menstrual age)
时间窗: 1. 40 weeks post menstrual age. | 2. 72 hours of age.
2. Proportion of neonates with successful completion of the surfactant administration procedure in the first attempt
时间窗: 1. 40 weeks post menstrual age. | 2. 72 hours of age.
次要结局
- Need for second/repeat dose of surfactant(72 hours of life)
- Proportion of neonates who received surfactant early( less than 2 hrs of birth) & late( more than 2 hrs of birth)(72 hours of life)
- Proportion of neonates needing Invasive mechanical ventilation within first 3 days of life(72 hours of life)
- Max FiO2 level required to maintain preductal SpO2 between 91 to 95% before the administration of first dose of surfactant(72 hours of life)
- Number of attempts for intratracheal catheter passage(72 hours of life)
- Need for multiple attempts for successful surfactant administration(72 hours of life)
- Episodes of bradycardia during surfactant administration procedure(72 hours of life)
- Episodes of desaturation less than 80 percent during surfactant administration procedure(72 hours of life)
- Duration of non-invasive & invasive respiratory support before 40 weeks post menstrual age.(40 weeks Post menstrual age)
- Incidence of intubation during the surfactant administration procedure(72 hours of life)
- Proportion of neonates who had Pneumothorax post surfactant administration(72 hours of life)
- Maximum FiO2 requirement during the hospital stay(40 weeks Post menstrual age)
- Duration of hospital stay(40 weeks Post menstrual age)
- Incidence of BPD & its severity(40 weeks Post menstrual age)
- Incidence of ROP(40 weeks Post menstrual age)
- Incidence of IVH(40 weeks Post menstrual age)
- Mortality rate(40 weeks Post menstrual age)
研究者
Prithiviraj Kesavan
PGIMER, Chandigarh