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NCT02640703 Clinical Trial

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

Premature Birth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02640703
Other study ID # Impfstudie
Secondary ID
Status Completed
Phase Phase 3
First received December 12, 2015
Last updated October 24, 2017
Start date March 2015
Est. completion date May 2017

Study information
Verified date October 2017
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date May 2017
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 6 Months
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• Infanrix + Prevenar 13
Different time of application

Locations
Country Name City State
Germany University Childrens Hospital Tübingen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of hypoxia and bradycardia events 72 hours
Secondary 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)
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