drugset / Trial / NCT02640703

Effect of Morning vs. Evening Vaccination on Hypoxia and Bradycardia of Preterm Infants: a Randomised Controled Trial

NCT02640703

Phase 3 Completed 16 enrolled University Hospital Tuebingen
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2015-03
Primary completion
2016-12
Completion
2017-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adacel Vaccine
Comparator Prevnar 13 Vaccine

Indications

No indication recorded.