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

Phase 3

Completed

• Conditions: Premature Birth; Intermittent Hypoxiema
• Interventions: Biological: Infanrix + Prevenar 13

• Registration Number: NCT02640703
• Lead Sponsor: University Hospital Tuebingen

Brief 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

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-12-12
• Study First Submitted QC: 2015-12-22
• Study First Posted: 2015-12-29
• Primary Completion: 2016-12
• Study Completion: 2017-05
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• gestational Age: 26+0 to 30+6 Weeks of gestational age

Exclusion Criteria

• bronchopulmonary dysplasia
• periventricular leukomalacia
• intraventricular hemorrhage >°2
• congenital malformations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
morning vaccination	Infanrix + Prevenar 13	Vaccination with Infanrix + Prevenar 13 between 7 and 10 am
evening vaccination	Infanrix + Prevenar 13	Vaccination with Infanrix + Prevenar 13 between 7 and 10 pm

Primary Outcome Measures

Name	Time	Method
Number of hypoxia and bradycardia events	72 hours

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University Childrens Hospital; 🇩🇪 Tübingen, Germany