Premature Birth Clinical Trial
Official title:
Effect of Morning vs. Evening Vaccination on Hypoxia and Bradycardia of Preterm Infants: a Randomised Controled Trial
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.
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
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