Noninvasive Ventilation Strategies for Early Treatment of RDS in Preterm Infants: An RCT
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 280
- 主要终点
- Failure of NIV Support
研究概览
简要总结
The purpose of this study is to determine whether two different strategies of Non Invasive Ventilation (NIV) have different effect on length and failure of NIV support in preterm infants with respiratory distress syndrome (RDS).
详细描述
A Randomized Control Trial (RCT) conducted in two tertiary level Neonatal Intensive Care Unit (NICU). Ethical approval is needed. Informed and written consent will be obtained prior the delivery from the parents of the babies before the inclusion in the study. All inborn Very Low Birth Weight (VLBW) infants (Birthweight less than 1500 g and Gestational Age < 32 weeks) with signs of RDS, spontaneously breathing and only supported by nasal-Continuous Positive Airway Pressure (NCPAP) in NICU, will be randomized within the first 2 hours of life to receive two different Non Invasive Ventilation (NIV) strategies: Nasal Synchronized Intermittent Positive Pressure Ventilation (N-SIPPV) or Bilevel Continuous Positive Airway Pressure (BiPAP).
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
- — 至 2 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All inborn VLBW infants (birthweight less than 1500 g and Gestational Age < 32 wks) with signs of RDS, spontaneously breathing and only supported by N-CPAP, will be randomized within the first 2 hours of life to receive two different Non Invasive Ventilation (NIV) strategies.
排除标准
- •Apneic or severely depressed newborns requiring invasive ventilation, within two hours from birth
- •Newborns with genetic disease and/or with major congenital malformations
- •Newborns for whom it was not obtained informed consent within two hours from birth
结局指标
主要结局
Failure of NIV Support
时间窗: 10 days
NUMBER OF NEWBORNS WHO FAILED WITH NON INVASIVE VENTILATION SUPPORT AND NEEDED INTUBATION AND INVASIVE MECHANICAL VENTILATION.
Duration of NIV Support
时间窗: 10 days
DURATION OF NON INVASIVE VENTILATION SUPPORT FOR RDS TREATMENT
次要结局
- Pneumothorax (PNX)(10 days)
- Periventricular Leukomalacia (PVL)(3 month of life)
- Newborns Who Received Multiple Surfactant Doses(10 days)
- Death(1 month)
- Intraventricular Hemorrhage (IVH)(1 month of life)
- Late Onset Sepsis(after fifth days of life up 2 month of life)
- Bronchopulmonary Dysplasia (BPD)(36 weeks of postconceptional age or time of discharge)
- Retinopathy of Prematurity (ROP)(3 month of life)
- Patent Ductus Arteriosus Requiring Pharmacological Treatment (PDA)(first week of life)
- Necrotizing Enterocolitis (NEC)(1 month)
- Early Onset Sepsis(5days from birth)
研究者
Vincenzo Salvo, MD
MD, Neonatal Intensive Care Unit, Pediatric Department
Azienda Ospedaliera Universitaria Policlinico