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Completed

NCT Number: NCT02640703

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

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.

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Intermittent Hypoxiema Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

30 day–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Childrens Hospital

Tübingen, 72076, Germany

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Infanrix + Prevenar 13

Biological

Different time of application

Primary outcomes

  1. Number of hypoxia and bradycardia events

    Time frame: 72 hours

Secondary outcomes

  1. Vaccination titer in blood sample after vaccination compared to vaccination titer in blood sample before vaccination

    Time frame: Before vaccination and at the age of 4 months (corrected age)

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Dec 29, 2015
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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