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

University Hospital Tuebingen

Status and phase: Completed; Phase 3

Conditions: Intermittent Hypoxiema; Premature Birth

Treatments: Biological: Infanrix + Prevenar 13

Study type: Interventional

Funder types: Other

Identifiers

NCT02640703

Impfstudie

Details and patient eligibility

About

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.

Full 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

Enrollment: 16 patients

Sex: All

Ages: 30 days to 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

morning vaccination

Active Comparator group

Description:

Vaccination with Infanrix + Prevenar 13 between 7 and 10 am

Treatment:

Biological: Infanrix + Prevenar 13

evening vaccination

Active Comparator group

Description:

Vaccination with Infanrix + Prevenar 13 between 7 and 10 pm

Treatment:

Biological: Infanrix + Prevenar 13