Premature InfantCOCkPITNCT03877198
Comparison of Oxygen Controllers in Preterm InfanTs
A study of Premature Infant and Respiratory Insufficiency, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Premature infants often receive respiratory support and supplemental oxygen for a prolonged period of time during their admission in the NICU. While maintaining the oxygen saturation within a narrow target range is important to prevent morbidity, manual oxygen titration can be very challenging. Read more about this study
- Who is it for?
- Ages Up to 8 weeks
- Conditions the study is for
- Premature Infant, Respiratory Insufficiency, Hypoxia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Feb 2019to 13 Feb 2020
- 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 Up to 8 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants with a gestational age (GA) at birth of 24 - 29+6/7 weeks
- Receiving invasive mechanical ventilation or non-invasive respiratory support (NCPAP or NIPPV)
- Receiving supplemental oxygen (defined as FiO2 ≥ 0.25) at the time of enrollment and for at least 18 hours during the previous 24 hours; Or a coefficient of variation in supplemental oxygen of ≥ 0.1 in the previous 24 hours.
- Expected to complete the 49-hour or 50-hour study period in the current form of respiratory support, i.e. invasive mechanical ventilation or non-invasive respiratory support
- Written informed parental consent must be present.
Who cannot join
- Major congenital anomalies
- Arterial hypotension requiring vasopressor therapy within 48 hours prior to enrollment.
- If the attending physician considers the infant not stable enough for a switch to another ventilator.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333
About this study
Official title: A Randomized Cross-over Trial in the Effect of Automated Oxygen Control Devices on the Distribution of Oxygen Saturation in Preterm Infants
Premature infants often receive respiratory support and supplemental oxygen for a prolonged period of time during their admission in the NICU. While maintaining the oxygen saturation within a narrow target range is important to prevent morbidity, manual oxygen titration can be very challenging. Automatic titration by a controller has been proven to be more effective. However, to date the performance of different controllers has not been compared. The proposed randomized crossover trial Comparing Oxygen Controllers in Preterm InfanTs (COCkPIT) is designed to compare the effect on time spent within target range. The results of this trial will help determining which algorithm is most successful in controlling oxygen, improve future developments in automated oxygen control and ultimately reduce the morbidity associated with hypoxemia and hyperoxemia.
Read the detailed description
Both hypoxemia as hyperoxemia can potentially be harmful to premature infants. Oxygen titration during respiratory support is vital to prevent these conditions but is very challenging. In the investigator's neonatal intensive care unit preterm infants routinely receive automatic oxygen titration performed by a controller. The currently used controllers are both proven to be more effective than manual titration, however which of the two controllers is most effective in keeping oxygen saturation within target range remains unclear.
This randomized crossover trial tests tests both controllers within every study patient to determine which controller is most effective and thereby would hopefully reduce morbidity associated with hypoxemia and hyperoxemia the most. The primary outcome measure is the proportion of time spent within target range, each controller will be tested for 24 hours within the same study subject. This is excluding a 1-hour wash-out period after a change in ventilator.
Eligible infants are randomized to start with either the Oxygenie algorithm or CLiO2 algorithm and will switch to the other study arm after 24 hours of measurement.
- Conditions
- Premature Infant, Respiratory Insufficiency, Hypoxia, Hyperoxia
- Being tested
- Automated oxygen control by the CLiO2 algorithm, Automated oxygen control by the Oxygenie algorithm
- Medical subject headings
- Premature Birth, Respiratory Insufficiency, Hypoxia, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated oxygen control by the CLiO2 algorithmDevice
Also called AVEA CLiO2
Automated oxygen control for 24 hours by the CLiO2 algorithm, preceded by a 1 hour wash-out period
Automated oxygen control by the Oxygenie algorithmDevice
Also called SLE Oxygenie
Automated oxygen control for 24 hours by the Oxygenie algorithm, in case of switch in ventilator preceded by a 1-hour wash-out period.
| Study group | Role | What they receive |
|---|---|---|
| CLiO2 | Experimental | Automated oxygen control by the CLiO2 algorithm Receives: Device: Automated oxygen control by the CLiO2 algorithm |
| Oxygenie | Experimental | Automated oxygen control by the Oxygenie algorithm Receives: Device: Automated oxygen control by the Oxygenie algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of time with SpO2 spent within set target range
Total time SpO2 is within the set target range (91-95%) including time spent above target range when in room air (set FiO2 < 0.22)
Measured: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Secondary outcomes (13)
Proportion of time with SpO2 spent above target range (SpO2 > 95%)
Measured: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Proportion of time with SpO2 spent below target range (SpO2 < 91%)
Measured: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Coefficient of SpO2 variation
Measured: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Time in hypoxemic SpO2 ranges
Time in SpO2 range 85-90%, 80-84% and <80%
Measured: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Time in hyperoxemic SpO2 ranges
Time in SpO2 range 96-98% and >98%
Measured: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Frequency of episodes of hypoxemia
Episodes in hypoxemia with SpO2 < 85% for ≥ 30 seconds, for ≥ 60 seconds and hypoxemia < 80% for ≥ 30 seconds and ≥ 60 seconds
Measured: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Frequency of episodes of hyperoxemia
Episodes in hyperoxemia with SpO2 ≥ 97% for ≥ 30 seconds, for ≥ 60 seconds and hyperoxemia ≥ 99% for ≥ 30 seconds and ≥ 60 seconds
Measured: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Frequency of episodes of bradycardia
Episodes where the heart rate < 100 beats per minute for ≥ 10 seconds
Measured: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Frequency of FiO2 adjustments during automated control
FiO2 adjustments as made by the controller and by bedside staff as manual over-rides by the bedside staff as well
Measured: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Average oxygen exposure
Measured: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Coefficient of variation of FiO2
Measured: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Effects on nursing workload in relation to FiO2 adjustment
Number of manual FiO2 adjustments and as the effect on workload measured by a translated questionnaire adapted from the NASA TLX questionnaire, using a visual rating scale
Measured: From randomization until study completion. (maximum of 50 hours) Manual adjustments during wash-out periods will be excluded.
Confidence of the bedside staff in the automated control system
Measured at the end of each nursing shift by a subset of questions out of the System Trust Scale (Jian et al. 2000) questionnaire. All questions are answered on a 1 (not at all) to 7 (extremely) scale.
Measured: From randomization until study completion. (maximum of 50 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start19 Feb 2019
- Primary completion13 Feb 2020
- Study completion13 Feb 2020
Why it stopped: As a result of a slower inclusion rate than expected, competence of medical staff to work with the AVEA ventilator could no longer be guaranteed.
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 Premature InfantStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tasmania
- Responsible party
- Principal investigator, PasABte, Leiden University Medical Center
- Investigators
- Arjan B te Pas, Prof, Principal investigator, Leiden University Medical CenterPeter A Dargaville, Prof, Principal investigator, University of Tasmania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877198
- Sponsor's protocol ID
- COCkPIT
- Other IDs
- NL66058.000.18
- Acronym
- COCkPIT
- Status last verified
- Jun 2020
- First submitted
- 12 Mar 2019
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Salverda HH, Cramer SJE, Witlox RSGM, Gale TJ, Dargaville PA, Pauws SC, Te Pas AB. Comparison of two devices for automated oxygen control in preterm infants: a randomised crossover trial. Arch Dis Child Fetal Neonatal Ed. 2022 Jan;107(1):20-25. doi: 10.1136/archdischild-2020-321387. Epub 2021 Jun 10.
PubMed 34112721
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cross-over Trial in the Effect of Automated Oxygen Control Devices on the Distribution of Oxygen Saturation in Preterm Infants
- ClinicalTrials.gov ID
- NCT03877198
- Acronym / sponsor ID
- COCkPIT / COCkPIT
- Conditions
- Premature Infant, Respiratory Insufficiency, Hypoxia, Hyperoxia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: As a result of a slower inclusion rate than expected, competence of medical staff to work with the AVEA ventilator could no longer be guaranteed.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- University of Tasmania
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 13 Feb 2020 (actual)
- Study completion
- 13 Feb 2020 (actual)
- First posted
- 15 Mar 2019 (actual)
- 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.
Premature infants often receive respiratory support and supplemental oxygen for a prolonged period of time during their admission in the NICU. While maintaining the oxygen saturation within a narrow target range is important to prevent morbidity, manual oxygen titration can be very challenging. Automatic titration by a controller has been proven to be more effective. However, to date the performance of different controllers has not been compared. The proposed randomized crossover trial Comparing Oxygen Controllers in Preterm InfanTs (COCkPIT) is designed to compare the effect on time spent within target range. The results of this trial will help determining which algorithm is most successful in controlling oxygen, improve future developments in automated oxygen control and ultimately reduce the morbidity associated with hypoxemia and hyperoxemia.
Detailed description
Both hypoxemia as hyperoxemia can potentially be harmful to premature infants. Oxygen titration during respiratory support is vital to prevent these conditions but is very challenging. In the investigator's neonatal intensive care unit preterm infants routinely receive automatic oxygen titration performed by a controller. The currently used controllers are both proven to be more effective than manual titration, however which of the two controllers is most effective in keeping oxygen saturation within target range remains unclear.
This randomized crossover trial tests tests both controllers within every study patient to determine which controller is most effective and thereby would hopefully reduce morbidity associated with hypoxemia and hyperoxemia the most. The primary outcome measure is the proportion of time spent within target range, each controller will be tested for 24 hours within the same study subject. This is excluding a 1-hour wash-out period after a change in ventilator.
Eligible infants are randomized to start with either the Oxygenie algorithm or CLiO2 algorithm and will switch to the other study arm after 24 hours of measurement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLiO2 | Experimental | Device: Automated oxygen control by the CLiO2 algorithmAutomated oxygen control by the CLiO2 algorithm |
| Oxygenie | Experimental | Device: Automated oxygen control by the Oxygenie algorithmAutomated oxygen control by the Oxygenie algorithm |
Who may qualify
- Ages
- Up to 8 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Preterm infants with a gestational age (GA) at birth of 24 - 29+6/7 weeks
- Receiving invasive mechanical ventilation or non-invasive respiratory support (NCPAP or NIPPV)
- Receiving supplemental oxygen (defined as FiO2 ≥ 0.25) at the time of enrollment and for at least 18 hours during the previous 24 hours; Or a coefficient of variation in supplemental oxygen of ≥ 0.1 in the previous 24 hours.
- Expected to complete the 49-hour or 50-hour study period in the current form of respiratory support, i.e. invasive mechanical ventilation or non-invasive respiratory support
- Written informed parental consent must be present.
Key exclusion criteria (3 listed)
- Major congenital anomalies
- Arterial hypotension requiring vasopressor therapy within 48 hours prior to enrollment.
- If the attending physician considers the infant not stable enough for a switch to another ventilator.
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 oxygen control by the CLiO2 algorithmAlso: AVEA CLiO2Automated oxygen control for 24 hours by the CLiO2 algorithm, preceded by a 1 hour wash-out period | Device | CLiO2 |
| Automated oxygen control by the Oxygenie algorithmAlso: SLE OxygenieAutomated oxygen control for 24 hours by the Oxygenie algorithm, in case of switch in ventilator preceded by a 1-hour wash-out period. | Device | Oxygenie |
Primary outcome
Proportion of time with SpO2 spent within set target range
Time frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Total time SpO2 is within the set target range (91-95%) including time spent above target range when in room air (set FiO2 < 0.22)
13 secondary outcomes
Proportion of time with SpO2 spent above target range (SpO2 > 95%)
Time frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Proportion of time with SpO2 spent below target range (SpO2 < 91%)
Time frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Coefficient of SpO2 variation
Time frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Time in hypoxemic SpO2 ranges
Time frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Time in hyperoxemic SpO2 ranges
Time frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Frequency of episodes of hypoxemia
Time frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Frequency of episodes of hyperoxemia
Time frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Frequency of episodes of bradycardia
Time frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Frequency of FiO2 adjustments during automated control
Time frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Average oxygen exposure
Time frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Coefficient of variation of FiO2
Time frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.
Effects on nursing workload in relation to FiO2 adjustment
Time frame: From randomization until study completion. (maximum of 50 hours) Manual adjustments during wash-out periods will be excluded.
Confidence of the bedside staff in the automated control system
Time frame: From randomization until study completion. (maximum of 50 hours)
Results and safety
The study was stopped early (reason given: As a result of a slower inclusion rate than expected, competence of medical staff to work with the AVEA ventilator could no longer be guaranteed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Derived from this study: PubMed 34112721Salverda HH, Cramer SJE, Witlox RSGM, Gale TJ, Dargaville PA, Pauws SC, Te Pas AB. Comparison of two devices for automated oxygen control in preterm infants: a randomised crossover trial. Arch Dis Child Fetal Neonatal Ed. 2022 Jan;107(1):20-25. doi: 10.1136/archdischild-2020-321387. Epub 2021 Jun 10.
- Individual participant dataSharing planned: Undecided
Related trials for Premature Infant
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
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.
Arjan B te Pas, Prof principal investigator
Leiden University Medical Center
Peter A Dargaville, Prof principal investigator
University of Tasmania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Premature Infant and Respiratory Insufficiency, run by Leiden University Medical Center at 1 site in Netherlands.
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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 9 Jun 2020. 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 Netherlands. 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?
The study was stopped early (reason given: As a result of a slower inclusion rate than expected, competence of medical staff to work with the AVEA ventilator could no longer be guaranteed.). Results are not available in the source record.
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?
Proportion of time with SpO2 spent within set target range (time frame: Continuously from randomization until study completion. (maximum of 50 hours) Measurements during wash-out periods (up to 1 hour after ventilator switch) will be excluded.). 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 NCT03877198, 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 9 Jun 2020.