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

NCT02640703 | Completed Phase 3

• 1 other identifier: Impfstudie
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth; Intermittent Hypoxiema

Outcome Measures

Primary Outcomes (1)

• Number of hypoxia and bradycardia events

  72 hours

Secondary Outcomes (1)

• 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)

Study Arms (2)

morning vaccination

ACTIVE COMPARATOR

Vaccination with Infanrix + Prevenar 13 between 7 and 10 am

Biological: Infanrix + Prevenar 13

evening vaccination

ACTIVE COMPARATOR

Vaccination with Infanrix + Prevenar 13 between 7 and 10 pm

Biological: Infanrix + Prevenar 13

Interventions

Infanrix + Prevenar 13 BIOLOGICAL

Different time of application

evening vaccination; morning vaccination

Eligibility Criteria

• Age: 30 Days - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Childrens Hospital

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Diphtheria-Tetanus-acellular Pertussis Vaccines; 13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pertussis Vaccine; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit

Study Officials

• Christian F. Poets, Prof.

  Dept. of Neonatology, Tuebingen University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Christian F. Poets

Study Record Dates

• First Submitted: December 12, 2015
• First Posted: December 29, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: October 25, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)