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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02640703

Enrollment

Registered

2015-12-29

Start date

2015-03-31

Completion date

2017-05-31

Last updated

2017-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent Hypoxiema, Premature Birth

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

Interventions

BIOLOGICALInfanrix + Prevenar 13

Different time of application

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Days to 6 Months

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* bronchopulmonary dysplasia * periventricular leukomalacia * intraventricular hemorrhage \>°2 * congenital malformations

Design outcomes

Primary

Measure	Time frame
Number of hypoxia and bradycardia events	72 hours

Secondary

Measure	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)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026