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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| morning vaccination | Active Comparator | Vaccination with Infanrix + Prevenar 13 between 7 and 10 am |
|
| evening vaccination | Active Comparator | Vaccination with Infanrix + Prevenar 13 between 7 and 10 pm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infanrix + Prevenar 13 | Biological | Different time of application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of hypoxia and bradycardia events | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian F. Poets, Prof. | Dept. of Neonatology, Tuebingen University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Childrens Hospital | Tübingen | 72076 | Germany |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D022681 | Diphtheria-Tetanus-acellular Pertussis Vaccines |
| C538862 | 13-valent pneumococcal vaccine |
| ID | Term |
|---|---|
| D010567 | Pertussis Vaccine |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| D000091642 | Urogenital Diseases |
| D045424 |
| Complex Mixtures |
| D004168 | Diphtheria Toxoid |
| D014121 | Toxoids |
| D013745 | Tetanus Toxoid |
| D017778 | Vaccines, Combined |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |