Intermittent HypoxemiaNCT02743988
Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants
A study testing Oxygen in people with Intermittent Hypoxemia and Apnea of Prematurity, run by University of Ulm at 1 site in Germany.
Trial summary
In this randomized crossover trial, preterm infants with intermittent hypoxemia and need for supplemental oxygen will be randomized to either Sequence of two different oxygen target ranges (low: 85-89%; high: 91-95%) for a total duration of 19 hours. Read more about this study
- Who is it for?
- Ages 21 to 42 days
- Conditions the study is for
- Intermittent Hypoxemia, Apnea of Prematurity
- What is being tested?
- Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to Sep 2017
- 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 21 to 42 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm infant < 29 weeks gestation
- at least 8 hypoxemic events during 8 hours
- requires supplemental oxygen to achieve high SpO2 target range
- parental consent given
Who cannot join
- congenital life-threatening malformation
- fatal outcome expected
- airway malformation
- higher grade intraventricular bleeding (grade III or IV according to LA Papile)
- posthaemorrhagic hydrocephalus
- life-threatening disease at the time of study entry
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center, Ulm University
Ulm, Baden-Wurttemberg, 89075
Manuel B Schmid, +49 731 500 ext. 57218, manuel.schmid@uni-ulm.de
About this study
In this randomized crossover trial, preterm infants with intermittent hypoxemia and need for supplemental oxygen will be randomized to either Sequence of two different oxygen target ranges (low: 85-89%; high: 91-95%) for a total duration of 19 hours. Cerebral oxygenation, cardiac output, arterial oxygenation and heart rate will be measured continuously. Primary outcome is time with arterial oxygen saturation < 80%.
- Conditions
- Intermittent Hypoxemia, Apnea of Prematurity
- Being tested
- Oxygen
- Keywords
- cerebral oxygenation, NIRS, near-infrared spectroscopy, bradycardia, hypoxemia, cerebral perfusion, cardiac output, apnea, desaturation, oxygen saturation target range
- Medical subject headings
- Apnea, Bradycardia, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
Adapt inspired oxygen to achieve desired SpO2 target range
| Study group | Role | What they receive |
|---|---|---|
| Low target range | Experimental | Low oxygen saturation target range: SpO2 85-89% Receives: Drug: Oxygen |
| High target range | Active comparator | High oxygen saturation target range: SpO2 91-95% Receives: Drug: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration SpO2 < 80%
Measured: during 16 hours of measurement
Secondary outcomes (7)
Cerebral tissue oxygen saturation as measured by NIRS
Area under threshold
Measured: during 16 hours of measurement
Arterial SpO2 as measured by pulse oxymetry
Area under 80%
Measured: during 16 hours of measurement
Heart rate as measured by ECG
Area under 80/min
Measured: during 16 hours of measurement
cerebral and visceral fractional oxygen extraction as measured by NIRS
Measured: during 16 hours of measurement
Cardiac output as measured by Cardiovelocimetry
Measured: during 16 hours of measurement
Number of hypoxemic and / or bradycardic events
Measured: during 16 hours of measurement
Visceral tissue oxygen saturation as measured by NIRS
Area under threshold
Measured: during 16 hours of measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startMay 2015
- Primary completionApr 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent HypoxemiaStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Schmid, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743988
- Sponsor's protocol ID
- ULMNEONIRS05
- Status last verified
- Apr 2016
- First submitted
- 7 Apr 2016
- Last updated
- 19 Apr 2016
- 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 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants
- ClinicalTrials.gov ID
- NCT02743988
- Acronym / sponsor ID
- ULMNEONIRS05
- Conditions
- Intermittent Hypoxemia, Apnea of Prematurity
- Keywords
- cerebral oxygenation, NIRS, near-infrared spectroscopy, bradycardia, hypoxemia, cerebral perfusion, cardiac output, apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 19 Apr 2016 (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 randomized crossover trial, preterm infants with intermittent hypoxemia and need for supplemental oxygen will be randomized to either Sequence of two different oxygen target ranges (low: 85-89%; high: 91-95%) for a total duration of 19 hours. Cerebral oxygenation, cardiac output, arterial oxygenation and heart rate will be measured continuously. Primary outcome is time with arterial oxygen saturation < 80%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low target range | Experimental | Drug: OxygenLow oxygen saturation target range: SpO2 85-89% |
| High target range | Active comparator | Drug: OxygenHigh oxygen saturation target range: SpO2 91-95% |
Who may qualify
- Ages
- 21 to 42 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- preterm infant < 29 weeks gestation
- at least 8 hypoxemic events during 8 hours
- requires supplemental oxygen to achieve high SpO2 target range
- parental consent given
Key exclusion criteria (6 listed)
- congenital life-threatening malformation
- fatal outcome expected
- airway malformation
- higher grade intraventricular bleeding (grade III or IV according to LA Papile)
- posthaemorrhagic hydrocephalus
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 |
|---|---|---|
| OxygenAdapt inspired oxygen to achieve desired SpO2 target range | Drug | High target range, Low target range |
Primary outcome
Duration SpO2 < 80%
Time frame: during 16 hours of measurement
7 secondary outcomes
Cerebral tissue oxygen saturation as measured by NIRS
Time frame: during 16 hours of measurement
Arterial SpO2 as measured by pulse oxymetry
Time frame: during 16 hours of measurement
Heart rate as measured by ECG
Time frame: during 16 hours of measurement
cerebral and visceral fractional oxygen extraction as measured by NIRS
Time frame: during 16 hours of measurement
Cardiac output as measured by Cardiovelocimetry
Time frame: during 16 hours of measurement
Number of hypoxemic and / or bradycardic events
Time frame: during 16 hours of measurement
Visceral tissue oxygen saturation as measured by NIRS
Time frame: during 16 hours of measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen in people with Intermittent Hypoxemia and Apnea of Prematurity, 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Apr 2016. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manuel B Schmid, MD (+41762515201, manuel.schmid@uni-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration SpO2 < 80% (time frame: during 16 hours of measurement). 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 19 Apr 2016.