Premature BirthPhase 3NCT02640703
Effect of Morning vs. Evening Vaccination on Hypoxia and Bradycardia of Preterm Infants: a Randomised Controled Trial
A Phase 3 study testing Infanrix + Prevenar 13 in people with Premature Birth and Intermittent Hypoxiema, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 days to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Premature Birth, Intermittent Hypoxiema
- What is being tested?
- Infanrix + Prevenar 13
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2015to May 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 days to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- gestational Age: 26+0 to 30+6 Weeks of gestational age
Who cannot join
- bronchopulmonary dysplasia
- periventricular leukomalacia
- intraventricular hemorrhage >°2
- congenital malformations
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Premature Birth, Intermittent Hypoxiema
- Being tested
- Infanrix + Prevenar 13
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infanrix + Prevenar 13Biological
Different time of application
| Study group | Role | What they receive |
|---|---|---|
| morning vaccination | Active comparator | Vaccination with Infanrix + Prevenar 13 between 7 and 10 am Receives: Biological: Infanrix + Prevenar 13 |
| evening vaccination | Active comparator | Vaccination with Infanrix + Prevenar 13 between 7 and 10 pm Receives: Biological: Infanrix + Prevenar 13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hypoxia and bradycardia events
Measured: 72 hours
Secondary outcomes (1)
Vaccination titer in blood sample after vaccination compared to vaccination titer in blood sample before vaccination
Measured: Before vaccination and at the age of 4 months (corrected age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Christian Poets, University Hospital Tuebingen
- Investigators
- Christian F. Poets, Prof., Principal investigator, Dept. of Neonatology, Tuebingen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640703
- Sponsor's protocol ID
- Impfstudie
- Status last verified
- Oct 2017
- First submitted
- 12 Dec 2015
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Morning vs. Evening Vaccination on Hypoxia and Bradycardia of Preterm Infants: a Randomised Controled Trial
- ClinicalTrials.gov ID
- NCT02640703
- Acronym / sponsor ID
- Impfstudie
- Conditions
- Premature Birth, Intermittent Hypoxiema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| morning vaccination | Active comparator | Biological: Infanrix + Prevenar 13Vaccination with Infanrix + Prevenar 13 between 7 and 10 am |
| evening vaccination | Active comparator | Biological: Infanrix + Prevenar 13Vaccination with Infanrix + Prevenar 13 between 7 and 10 pm |
Who may qualify
- Ages
- 30 days to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- gestational Age: 26+0 to 30+6 Weeks of gestational age
Key exclusion criteria (4 listed)
- bronchopulmonary dysplasia
- periventricular leukomalacia
- intraventricular hemorrhage >°2
- congenital malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infanrix + Prevenar 13Different time of application | Biological | evening vaccination, morning vaccination |
Primary outcome
Number of hypoxia and bradycardia events
Time frame: 72 hours
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Individual participant dataSharing planned: No
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Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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Growing Little PEAPODS Study
Premature Birth, Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian F. Poets, Prof. principal investigator
Dept. of Neonatology, Tuebingen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Infanrix + Prevenar 13 in people with Premature Birth and Intermittent Hypoxiema, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hypoxia and bradycardia events (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.