HHHFNC (Heated Humidified High-Flow Nasal Cannula) Versus NCPAP (Nasal Continuous Positive Airway Pressure) in Preterm Infants With Mild to Moderate Respiratory Distress Syndrome (RDS): a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 316
- 试验地点
- 2
- 主要终点
- number of patients needing intubation and mechanical ventilation within 72 hrs from the beginning of the study mode
研究概览
简要总结
Preterm infants ranging from 29+0 to 36+6 weeks+days are randomly assigned to one of the following treatments as non invasive respiratory support if they develop mild to moderate Respiratory Distress Syndrome within 72 hrs from birth: 1) NCPAP set at 4-6 cmH2O or 2) HHHFNC providing a flow 4-6 l/min.
The aim of the study is to assess efficacy and safety of relative "new" form of respiratory support (HHHFNC) versus a more common one (NCPAP).
详细描述
Preterm infants are eligible to the study if they present mild to moderate Respiratory Distress Syndrome (RDS) defined by the following criteria: need of FiO2 ( Fraction of Inspired Oxygen) ≥0.30 to keep a target SpO2 (Periferal Oxygen Saturation) beetween 88-93% and/or Silverman score ≥5. To confirm the diagnosis a Chest XR is performed as routinarily in the ward before starting the respiratory support.
They are randomly assigned to one of the treatment groups cited in "brief summary" by means of closed envelops. A block randomization is applided with a blok size of 4. The randomization is stratified per groups accoring to gestational age: from 29+0 to 32+6; from 33+0 to 34+6; from 35+0 to 36+6 weeks+days.
Once the treatment is started, for the group NCPAP there is the possibility to switch to the mode "Bi-PAP" if: there are more than 4 episodes of apnoea per hour or more than 2 episodes requiring positive pressure ventilation or if deemed by clinicians for increased work of breathing assesed by the Silverman score.
For all the groups, if the FiO2 requirement is persistently higher than 0.35-0.40 per target SpO2 86-93% and/or dyspnoea defined by Silverman score > 6 after starting the respiratory support, newborns receive Surfactant by "INSURE" technique, involving endotracheal intubation by direct laryngoscopic vision, endotracheal administration of surfactant (Curosurf, Chiesi Pharmaceutics, Parma, Italy) 200 mg/kg and finally extubation.
After the administration of surfactant, if FiO2 requirement is persistently >0.4 to keep SpO2 86-93% or severe apnea episodes are present (apnea episodes > 4/hr or >2/hr requiring positive pressure ventilation) or at the blood gas (capillary or venous) PaCO2>70 mmHg and pH<7.20, newborns are intubated and mechanically ventilated.
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
- 29 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parental Consent
排除标准
- •No parental consent
- •Major congenital malformations
- •Severe intra ventricular hemorrage diagnosed early after birth
结局指标
主要结局
number of patients needing intubation and mechanical ventilation within 72 hrs from the beginning of the study mode
时间窗: within 72 hrs from the beginning of the study mode
The procedure defined as INSURE and described in details in the section "Detailed Study Description" is not considered as a failure for the primary outcome.
次要结局
- Intra ventricular Hemorrage(through study completion, an average of 1 year)
- air-leak syndrome(through study completion, an average of 1 year)
- Retinopathy of Prematurity(through study completion, an average of 1 year)
- overall duration of respiratory assistance(up to 2 years from birth)
- Necrotising Enterocolites (NEC)(through study completion, an average of 1 year)
- overall mortality(through study completion, an average of 1 year)
- overall duration of oxygen requirement(up to 2 years from birth)
- Surfactant treatment(through study completion, an average of 1 year)
- Infections(through study completion, an average of 1 year)
- Bronchopulmonary Dysplasia(up to 2 years from birth)
- Patent Doctus Arterious(through study completion, an average of 1 year)
- overall duration of non invasive respiratory assistance(up to 2 years from birth)
- full enteral feeding(through study completion, an average of 1 year)
- overall duration of hospitalisation(up to 2 years from birth)
研究者
Mariarosa Colnaghi
MD
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico