search
Back to results

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

Primary Purpose

Premature Birth, Intermittent Hypoxiema

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Infanrix + Prevenar 13
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Birth

Eligibility Criteria

30 Days - 6 Months (Child)All SexesAccepts 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

Sites / Locations

  • University Childrens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

morning vaccination

evening vaccination

Arm Description

Vaccination with Infanrix + Prevenar 13 between 7 and 10 am

Vaccination with Infanrix + Prevenar 13 between 7 and 10 pm

Outcomes

Primary Outcome Measures

Number of hypoxia and bradycardia events

Secondary Outcome Measures

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

Full Information

First Posted
December 12, 2015
Last Updated
October 24, 2017
Sponsor
University Hospital Tuebingen
search

1. Study Identification

Unique Protocol Identification Number
NCT02640703
Brief Title
Effect of Morning vs. Evening Vaccination on Hypoxia and Bradycardia of Preterm Infants: a Randomised Controled Trial
Official Title
Effect of Morning vs. Evening Vaccination on Hypoxia and Bradycardia of Preterm Infants: a Randomised Controled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth, Intermittent Hypoxiema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
morning vaccination
Arm Type
Active Comparator
Arm Description
Vaccination with Infanrix + Prevenar 13 between 7 and 10 am
Arm Title
evening vaccination
Arm Type
Active Comparator
Arm Description
Vaccination with Infanrix + Prevenar 13 between 7 and 10 pm
Intervention Type
Biological
Intervention Name(s)
Infanrix + Prevenar 13
Intervention Description
Different time of application
Primary Outcome Measure Information:
Title
Number of hypoxia and bradycardia events
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Days
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: gestational Age: 26+0 to 30+6 Weeks of gestational age Exclusion Criteria: bronchopulmonary dysplasia periventricular leukomalacia intraventricular hemorrhage >°2 congenital malformations
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian F. Poets, Prof.
Organizational Affiliation
Dept. of Neonatology, Tuebingen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Childrens Hospital
City
Tübingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs