Patient Comfort During High Flow Nasal Cannula (HFNC)Versus Nasal Continuous Airway Pressure (CPAP): a Cross Over Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Patient comfort (EDIN score)
研究概览
简要总结
Preterm children are at increased risk for developing lung disease due to immature lungs. Non-invasive ventilation (NIV) support is increasingly used as treatment. Nasal continuous positive airway pressure (nCPAP) is the most common NIV-mode. Recently, high flow nasal cannulas (HFNC) have become an alternative NIV-mode. Both nCPAP and HFNC provide increased pressure in the airways aiming to keep the lungs open. With nCPAP it is common to use short binasal prongs that fill the nostrils completely and are pressed tightly over the nose. With HFNC oxygen/air is administered via two small, thin cannulas located just inside the nostrils, but the nostrils are not blocked.
The aim of this study is to compare patient comfort in premature infants treated with nCPAP and HFNC. The investigators hypothesis is that HFNC increases patient comfort.
The study is a randomized cross over study (2 x 24 hours). Children eligible for inclusion should be born before 34 weeks of gestation and have moderate respiratory distress, thus be "in need" of nCPAP. During the study period (48 hours) the investigators will consider how the child tolerates treatment with nCPAP versus HFNC. Primary outcome is patient comfort assessed with the EDIN-score (Neonatal pain and comfort score). Secondary outcomes are stress hormone response (cortisol in saliva), surrounding noise and parental satisfaction. The child's breathing pattern will be carefully monitored. The study involves no extra painful investigations.
The investigators plan to recruit 20 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants admitted to the NICU at University Hospital of North Norway, Tromsoe, Norway (single center study)
- •Gestational age (GA) < 34 weeks
- •Corrected age < 34 weeks
- •Receiving nasal CPAP for respiratory distress
- •Respiratory "stable": FiO2 < 30%, pCO2 < 8,5 kPa and pH > 7.
- •GA < 29 weeks: Respiratory "stable" over last 72 h.
- •GA 29-33 weeks: Respiratory "stable" over last 24 h.
排除标准
- •Congenital anomalies
- •Ongoing treatment for hypoglycemia or infection
- •Other intercurrent disease requiring frequent blood sampling
结局指标
主要结局
Patient comfort (EDIN score)
时间窗: 48 h (CPAP 24 h and HFNC 24 h); cumulative EDIN score for each 24 epoch is calculated and a change between the two interventions are assessed
EDIN score (neonatal pain and comfort score) is a validated scoring system to assess pain and comfort in term and preterm infants. The cumulative EDIN score, based on three evaluations/24 h, is recorded for each 24 h epoch with HFNC or CPAP, respectively. The change in EDIN score between the two 24 h epochs are assessed.
次要结局
- Noise(Measured at 10 AM and 10 PM over 48 h (4 measurements))
- Stress hormone response (salivary cortisol)(Measured at 10 AM and 10 PM over 48 h (4 measurements))
- Parental satisfaction(Three questions answered after 24 h and 48 h)