NCT02640703

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 30 Days – 6 Months
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Premature Birth
• Intermittent Hypoxiema

Interventions

Type	Name	Description
BIOLOGICAL	Infanrix + Prevenar 13	Different time of application

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-12-01
• Completion: 2017-05-01
• First posted: 2015-12-29
• Last updated: 2017-10-25

Locations

1 site across 1 country: Germany