Preterm InfantFiO2-ContrNCT01942473
Effects of Automated Adjustment of FiO2 on Cerebral and Arterial Oxygenation in Preterm Infants
A study of Preterm Infant and RDS, run by University of Ulm at 1 site in Germany.
Trial summary
In this study the investigators test the hypothesis that automated FiO2 adjustment increases the time of brain tissue oxygenation within the intended reference range. Furthermore, the investigators studied the change in workload during automated FiO2 adjustment as compared to manual adjustment by the nursing staff. Read more about this study
- Who is it for?
- Ages 96 hours to 30 weeks
- Conditions the study is for
- Preterm Infant, RDS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Apr 2014
- Phase
- Interventional
- 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 96 hours to 30 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- postmenstrual age <30 wks GA at study time
- on nasal/nasopharyngeal CPAP or mechanical ventilation (including nasopharyngeal IMV)
- at least 4 desaturations (SpO2 <80%) during an 8 hour period within the 24h before the study using a standard pulse oximeter incorporated in the NICU (Dash 3000, General Electric, Freiburg; 10s averaging time, delay 10s)
Who cannot join
- postnatal age <96h (to exclude rapidly changing conditions during the early phase of RDS and to avoid handling of the infant during the critical period for IVH)
- congenital cyanotic heart disease
- no decision for full treatment support
- Average FiO2 during the last 24h bevor the active study phase >0.60
- Congenital malformations of the lung or the diaphragm (i.e. diaphragmatic hernia, congentital cystic lung diseases...)
- Clinically clear evidence for seizures
- Ongoing Sepsis (CRP > 10mg/l, or positive blood culture, requirement of catecholamines)
- Need of blood-transfusion during study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Automated Adjustment of Inspired Oxygen on Fluctuations of Regional Cerebral and Arterial Oxygenation in Preterm Infants With Frequent Desaturations
In this study the investigators test the hypothesis that automated FiO2 adjustment increases the time of brain tissue oxygenation within the intended reference range. Furthermore, the investigators studied the change in workload during automated FiO2 adjustment as compared to manual adjustment by the nursing staff.
Read the detailed description
Recorded data on brain tissue oxygenation will be compared with reference data obtained from other studies. Data from experimental mode (automated FiO2 control will be compared with manual FiO2 control).
- Conditions
- Preterm Infant, RDS
- Being tested
- Automated FiO2 Control
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated FiO2 ControlDevice
Infants will be ventilated with or without automated FiO2-Control in a randomized sequence.
| Study group | Role | What they receive |
|---|---|---|
| Automated FiO2 control | Experimental | Infants will be changed to a specific ventilator device approved for clinical use in neonates in Germany (Avea, Carefusion 234 GmbH Hoechberg, Germany), which is capable to automatically adjust the FiO2 based on readings of an incorporated SpO2 monitoring device. Infants will be allowed to adjust for at least 2h using the ventilator settings as chosen by the clinical team responsible. Thereafter, data will be recorded for 24h experimental time. Receives: Device: Automated FiO2 Control |
| Manual Adjustment | Placebo comparator | Infants will be exposed to the first study phase (clinical routine or automated FiO2 adjustment) for 24 h and then will be switched to the alternate mode (automated FiO2 adjustment or clinical routine) for another 24 h. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral tissue oxygen saturation
mean cerebral tissue oxygen saturation as well als distribution of cerebral tissue oxygen saturation over time will be assessed
Measured: 48 hours
Secondary outcomes (3)
number and mean duration of episodes with an SpO2 <80%, <75%, <70% and with hyperoxemia (SpO2 >96%)
The number and mean duration of expisodes of desaturation and with hyperoxemia will be assessed
Measured: 48 hours
time within a defined target range of cerebral oxygen saturation (59% - 81%)
time (as measured as the percentage of the total recording time) within a defined target range of cerebral oxygen saturation (59% - 81%) which corresponds to the 10th and 90th percentile obtained from a pilot study in 16 preterm infants with desaturations during the time when their SpO2 was aimed within the target range of a SpO2 of (88-96%).
Measured: 48 hours
workload for the medical staff related to number of adjustments of FiO2
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startAug 2012
- Primary completionSep 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Helmut Hummler, University of Ulm
- Investigators
- Markus Waitz, MD, Principal investigator, Children's Hospital, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942473
- Sponsor's protocol ID
- FiO2_Ulm
- Acronym
- FiO2-Contr
- Status last verified
- Nov 2014
- First submitted
- 3 Aug 2012
- Last updated
- 26 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Waitz M, Schmid MB, Fuchs H, Mendler MR, Dreyhaupt J, Hummler HD. Effects of automated adjustment of the inspired oxygen on fluctuations of arterial and regional cerebral tissue oxygenation in preterm infants with frequent desaturations. J Pediatr. 2015 Feb;166(2):240-4.e1. doi: 10.1016/j.jpeds.2014.10.007. Epub 2014 Nov 18.
PubMed 25454938
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Automated Adjustment of Inspired Oxygen on Fluctuations of Regional Cerebral and Arterial Oxygenation in Preterm Infants With Frequent Desaturations
- ClinicalTrials.gov ID
- NCT01942473
- Acronym / sponsor ID
- FiO2-Contr / FiO2_Ulm
- Conditions
- Preterm Infant, RDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 16 Sep 2013 (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.
In this study the investigators test the hypothesis that automated FiO2 adjustment increases the time of brain tissue oxygenation within the intended reference range. Furthermore, the investigators studied the change in workload during automated FiO2 adjustment as compared to manual adjustment by the nursing staff.
Detailed description
Recorded data on brain tissue oxygenation will be compared with reference data obtained from other studies. Data from experimental mode (automated FiO2 control will be compared with manual FiO2 control).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automated FiO2 control | Experimental | Device: Automated FiO2 ControlInfants will be changed to a specific ventilator device approved for clinical use in neonates in Germany (Avea, Carefusion 234 GmbH Hoechberg, Germany), which is capable to automatically adjust the FiO2 based on readings of an incorporated SpO2 monitoring device. Infants will be allowed to adjust for at least 2h using the ventilator settings as chosen by the clinical team responsible. Thereafter, data will be recorded for 24h experimental time. |
| Manual Adjustment | Placebo comparator | –Infants will be exposed to the first study phase (clinical routine or automated FiO2 adjustment) for 24 h and then will be switched to the alternate mode (automated FiO2 adjustment or clinical routine) for another 24 h. |
Who may qualify
- Ages
- 96 hours to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- postmenstrual age <30 wks GA at study time
- on nasal/nasopharyngeal CPAP or mechanical ventilation (including nasopharyngeal IMV)
- at least 4 desaturations (SpO2 <80%) during an 8 hour period within the 24h before the study using a standard pulse oximeter incorporated in the NICU (Dash 3000, General Electric, Freiburg; 10s averaging time, delay 10s)
Key exclusion criteria (8 listed)
- postnatal age <96h (to exclude rapidly changing conditions during the early phase of RDS and to avoid handling of the infant during the critical period for IVH)
- congenital cyanotic heart disease
- no decision for full treatment support
- Average FiO2 during the last 24h bevor the active study phase >0.60
- Congenital malformations of the lung or the diaphragm (i.e. diaphragmatic hernia, congentital cystic lung diseases...)
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 |
|---|---|---|
| Automated FiO2 ControlInfants will be ventilated with or without automated FiO2-Control in a randomized sequence. | Device | Automated FiO2 control |
Primary outcome
Cerebral tissue oxygen saturation
Time frame: 48 hours
mean cerebral tissue oxygen saturation as well als distribution of cerebral tissue oxygen saturation over time will be assessed
3 secondary outcomes
number and mean duration of episodes with an SpO2 <80%, <75%, <70% and with hyperoxemia (SpO2 >96%)
Time frame: 48 hours
time within a defined target range of cerebral oxygen saturation (59% - 81%)
Time frame: 48 hours
workload for the medical staff related to number of adjustments of FiO2
Time frame: 48 hours
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 26 Nov 2014.
- Derived from this study: PubMed 25454938Waitz M, Schmid MB, Fuchs H, Mendler MR, Dreyhaupt J, Hummler HD. Effects of automated adjustment of the inspired oxygen on fluctuations of arterial and regional cerebral tissue oxygenation in preterm infants with frequent desaturations. J Pediatr. 2015 Feb;166(2):240-4.e1. doi: 10.1016/j.jpeds.2014.10.007. Epub 2014 Nov 18.
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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.
Markus Waitz, MD principal investigator
Children's Hospital, University of Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Preterm Infant and RDS, run by University of Ulm 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 3 inclusion and 8 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 26 Nov 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Cerebral tissue oxygen saturation (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01942473, which also lists 1 linked publication.
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 26 Nov 2014.