Nasal Olfactory Stimulation and Its Effect on Respiratory Drive in Preterm Infants - A Randomized Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Paired difference in the combined number of desaturations and bradycardia
研究概览
简要总结
This trial analyzes the effect of an olfactory stimulation with vanilla or strawberry aroma compared to placebo on desaturations and bradycardia in preterm infants with apnea of prematurity. Infants on continuous positive airway pressure (CPAP) support will be included and the aroma will be applied to the inner surface of the CPAP mask using designated scent pens. The trial uses a cross-over design. Infants are randomised to begin the study with either aroma or placebo which will be applied into the breathing mask every 3 to 4 hours during 12 hours for each of the two intervention periods. Identically looking pens with either aroma or placebo are used and patients, parents, medical staff and the study team are blinded to this allocation. Infants are monitored with an oximetry sensor to measure peripheral oxygen saturation (SpO2) and pulse rate.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
To blind the study team and the medical team, identically looking pens will be provided with and without vanilla or strawberry aroma.
入排标准
- 年龄范围
- 72 Hours 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age at birth: 23 0/7 to 31 6/7 weeks
- •Postnatal age: >72 hours old
- •Respiratory support: nCPAP
- •Treatment with caffeine citrate for apnea of prematurity
- •Written informed consent by one of the patient's parents
排除标准
- •Olfactory impairment such as choanal atresia
- •Intraparenchymal intracranial hemorrhage or intraventricular hemorrhage with ventricular dilation
- •Culture-proven sepsis during the study period or any acute clinical deterioration requiring an intervention such as intubation or a new start of antibiotic treatment.
- •Severe congenital malformation adversely affecting life expectancy
结局指标
主要结局
Paired difference in the combined number of desaturations and bradycardia
时间窗: 12-hour recording periods for each intervention
A desaturation is defined as a fall in the SpO2 to \<80% for more than 10 seconds, a bradycardia is defined as a fall in heart rate \<80 bpm for more than 10 seconds. Desaturation episodes and bradycardia separated by a time interval of five seconds or less will be counted as a single event. A desaturation episode as part of a bradycardia (or vice versa) will be counted as a two events. Peripheral oxygen saturation and heart rate will be monitored with an oximeter sensor placed around the infants' wrist or ankle and connected to the oximeter in 2 seconds averaging mode and maximum sensitivity.
次要结局
- Paired difference in time spent with heart rate <80 bpm(12-hour recording periods for each intervention)
- Paired difference in mean respiratory rate (as counted by nurses and manually) documented according to clinical routine) and heart rate(12-hour recording periods for each intervention)
- Paired difference in time spent with peripheral oxygen saturations <80%(12-hour recording periods for each intervention)
- Paired difference in desaturations requiring stimulation or increase in FiO2(12-hour recording periods for each intervention)
- Paired difference in fraction of inspired oxygen (FiO2)(12-hour recording periods for each intervention)
- Paired difference in mean peripheral oxygen saturation(12-hour recording periods for each intervention)
- Paired difference in the apnea score documented by nurses(12-hour recording periods for each intervention)
- Paired difference in tolerance of enteral nutrition as assessed by gastric residuals (the amount of stomach liquid detected prior to the next meal, in mL)(12-hour recording periods for each intervention)