Comparative study between intubate surfactant administration and extubate (INSURE) vs lesser invasive surfactant administration(LISA) technique for delivery of surfactant in newborn with respiratory distress syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Need for mechanical ventilation in first 72 hours in preterm newborns with RDS administered surfactant by LISA and INSURE.
研究概览
简要总结
This prospective study will be conducted in Department of Pediatrics, Swami Dayanand Hospital after obtaining the approval of Hospital Institutional Research Committee (HIRC) & Hospital Institutional Ethics Committee (HIEC). Preterm baby admitted to the NICU with a diagnosis ofrespiratory distress syndrome satisfying the inclusion criteria will be recruited after informed consent from the legal guardian. A detailed maternal and neonatal history and clinical examination of neonatal included in study will be carried out and recorded on a predesigned Performa.
Block randomisation will be done by person who is not involved in the study using research randomizer from www.sealedenvelope.com. All the spontaneously breathing preterm neonates born in SDNH at <36weeks of gestation, who develop RDS, will be included in the study. Both groups will be placed on nCPAP or HHHNC or Low Flow oxygenwith FiO2 (>30%) adjusted to maintain O2 saturations of 90-95%.
They will be given surfactant, if needed during first 12 hours of life.
RDS will be diagnosed on the basis of prematurity, tachypnea with respiratory rate >60/minute, subcostal or intercostal chest recession, grunting, nasal flaring, and cyanosis. Respiratory support will be provided with an initial pressure of 5 to 7 cm of water and FiO2 of 0.3. They will be randomized into two groups for the technique of surfactant administration, LISA or INSURE.
In LISA group, surfactant will be administered at a dose of 100 mg/Kg with the help of small catheter i.e LISA cathetor. Upper respiratory tract will be visualized with laryngoscope and the catheter will be passed 1-2 cm past the vocal cords. Surfactant will be delivered within 1-3 minutes in small aliquots, while the infant continue breathing with nCPAP, during and after the procedure.. The LISA catheter will beremoved immediately after the procedure. Infant’s heart rate and SpO2 will be monitored during the procedure via pulse oximetry. FiO2 will be adjusted to attain a target SpO2.
In INSURE group, the infants will be intubated and surfactant will be administered successfully in 2-3 aliquots with endotracheal tube with same dose as in LISA group, while they will receive positive pressure ventilation via T-piece resuscitaire. After a brief period of positive pressure ventilation for 15-20 minutes, the endotracheal will be removed and the infants will be placed on nCPAP.
The criteria for subsequent dose of surfactant and mechanical ventilation will be the same as in LISA group. All the data variables will be recorded for both groups on a specifically designed performa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 1.00 Day(s)（—）
- 性别
- All
入选标准
- •Preterm 28-36 weeks 2)Requirement of nasal continues airway pressure(ncpap) level beyond or equal to 5cm of water and fiO2 greater or equal to o.
- •30 to maintain sPO2 of 88-92%.
- •Requirement of nasal high flow nasal canula(NHHHFNC) level beyond or equal to 5L/min cm of water and fiO2 greater or equal to 0.3 to maintain sPO2 of 88-92%.
- •Requirement of free flow O2 to 2L/min cm of water and fiO2 greater or equal to 0.3 to maintain sPO2 of 88-92%.
排除标准
- •Severe respiratory distress syndrome with high oxygen requirement and or severe respiratory acidocissuch that ventilatory support will be necessary after surfactant therapy, suggested FiO2 threshold at which intubation for surfactant will be considered is >60(lower threshold) 2)Pulmonary hypoplasia 3)Cyanotic heart disease 4)Antinatally diagnosed congenital lung anomalies 5)Requirement intubation for resuscitation at birth.
结局指标
主要结局
Need for mechanical ventilation in first 72 hours in preterm newborns with RDS administered surfactant by LISA and INSURE.
时间窗: Birth till first 72 hours
次要结局
- Duration of mechanical ventilation needed between LISA and INSURE group(Duration of hospital stay between the LISA AND INSURE group)