Effect of Morning vs. Evening Vaccination on Hypoxia and Bradycardia of Preterm Infants: a Randomised Controled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Number of hypoxia and bradycardia events
研究概览
简要总结
Hypoxia/bradycardia are common symptoms after vaccination of preterm infants. Adults show diurnal variations in vaccination response, due to circadian regulation of the immune system. The investigators plan to investigate whether preterm infants also show differences in hypoxia/bradycardia rate upon morning vs. evening vaccination.
Hypoxia/bradycardia is recorded by pulse oximetry starting 24 hours before until 48 hours after vaccination; parents also kept a sleep-diary. 24 hours after vaccination interleukin-6, interleukin-1β and C-reactive protein get determined. To control vaccination response, pertussis- and haemophilus-titers are determined before vaccination and at 4 months corrected age.
详细描述
Intervention: First hexavalent vaccination given to very preterm infants either in the evening or in the morning.
Primary outcome: rate of desaturations (SpO2 <80%) and bradycardias (Pulse rate <100/min) in first 24 h following vaccination in evening vs. morning vaccination group Secondary outcomes: cytokine levels (IL 6, IL 1ß, CRP) measured 24 h after vaccination, pertussis- and haemophilus-titers as measured before and after vaccination, i.e. at 4 months corrected age, in evening vs. morning vaccination group
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
- 30 Days 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •gestational Age: 26+0 to 30+6 Weeks of gestational age
排除标准
- •bronchopulmonary dysplasia
- •periventricular leukomalacia
- •intraventricular hemorrhage >°2
- •congenital malformations
研究组 & 干预措施
morning vaccination
Vaccination with Infanrix + Prevenar 13 between 7 and 10 am
干预措施: Infanrix + Prevenar 13 (Biological)
evening vaccination
Vaccination with Infanrix + Prevenar 13 between 7 and 10 pm
干预措施: Infanrix + Prevenar 13 (Biological)
结局指标
主要结局
Number of hypoxia and bradycardia events
时间窗: 72 hours
次要结局
- Vaccination titer in blood sample after vaccination compared to vaccination titer in blood sample before vaccination(Before vaccination and at the age of 4 months (corrected age))
研究者
Prof. Dr. Christian Poets
Prof. Dr. med. Christian F. Poets
University Hospital Tuebingen