Effects of Vanilla on Hypoxic Intermittent Events in Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Desaturation Index
研究概览
简要总结
The purpose of this study is to evaluate the effect of vanilla odor on hypoxic intermittent events in premature infants born between 32.0 and 33.6 weeks of gestational age.
详细描述
A weekly screening will be done on all new hospitalized infants at the neonatal care unit of the CHUS born between 32.0 and 33.6 weeks of gestational age. At the beginning of their 2nd week in the neonatal care unit, infant's medical record will be consulted for inclusion and exclusion criteria. At this moment, no information will be noted. Then, team research will discuss with neonatologist to have their opinion concerning the inclusion of a patient in the study. If they agree, the doctor or the nurse having a therapeutic link with the infant will ask parents' infant if they agree to meet the research team to discuss about the research project. Once the agreement will be obtained, parents will be approached by a member of the research team. Project will be explained, questions will be answered and consent form will be obtained. When an infant will be enrolled in the study, a code will be attributed to him and a randomization will established the order of the intervention.
Option A) night 1: a 12h cardiorespiratory recording with vanilla, night 2: no recording and night 3: a 12h cardiorespiratory recording without vanilla OR Option B): night 1: a 12h cardiorespiratory recording without vanilla, night 2: no recording and night 3: a 12h cardiorespiratory recording recording with vanilla.
All data will be entered in a secured database and a double checked will be done by team members to assess the accuracy.
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
- None
入排标准
- 年龄范围
- 3 Weeks 至 4 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born between 30.0 and 34.0 weeks of gestational age;
- •Postnatal age between 3 and 4 weeks;
- •No current respiratory or ventilatory support;
- •Stable state for at least the last 48 hours;
- •Parental consent to enroll in the study.
排除标准
- •Respiratory diseases other than apnea;
- •Intraventricular hemorrhage grade 3 or 4 OR leukomalacia;
- •Chromosomal abnormality;
- •Congenital malformations which may result in cardiorespiratory or neurodevelopmental abnormality;
- •Clinical deterioration during the study.
结局指标
主要结局
Desaturation Index
时间窗: 12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odor
Number per hour of oxygen saturation \< 90% for at least 5 seconds
次要结局
- Percentage of Time of Oxygen Saturation Under 90%(12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odor)
- Percentage of Time of Periodic Breathing(12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odor)
- Time in Apnea(12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odor)
- Mean SpO2(12 hour period of recording on the night 1 and 3 of each participants, in which they are exposed to vanilla or no vanilla odor)
研究者
Jean-Paul Praud
MD, PhD
Université de Sherbrooke