Infantile Respiratory Distress SyndromeoptimalSPOCNCT03785899
Automatic Oxygen Control (SPOC) in Preterm Infants
A study testing SPOCnew, 8s SpO2 averaging and SPOCold in people with Infantile Respiratory Distress Syndrome and Ventilator Lung; Newborn, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Single-center, randomised controlled, cross-over clinical trial in preterm infants born at gestational age below 34+1/7 weeks receiving supplemental oxygen and respiratory support (continous positive airway pressure (CPAP) or non-invasive ventilation (NIV) or invasive ventilation (IV)). Read more about this study
- Who is it for?
- Ages Up to 34 weeks
- Conditions the study is for
- Infantile Respiratory Distress Syndrome, Ventilator Lung; Newborn
- What is being tested?
- SPOCnew, 8s SpO2 averaging and SPOCold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 3 Aug 2018to 1 Aug 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 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestational age at birth <34+1/7weeks and
- invasive mechanical ventilation OR noninvasive ventilation OR continous positive airway pressure support and
- Fraction of inspired oxygen above 0.21 before inclusion and
- more than 2 hypoxaemic events (arterial oxygen saturation below 80%) within 8 hours before inclusion and
- parental written informed consent
Who cannot join
- congenital pulmonary anomalies
- congenital heart defects influencing SpO2 (i.e. cyanotic heart defects)
- right-to -left shunt through a PDA
- Severe neonatal complications during study period (sepsis, necrotising enterocolitis)
- diaphragmatic hernia or other diaphragmatic disorders
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Neonatology, University Children's Hospital
Tübingen, 72076
Christoph E Schwarz, MD, +49707129-0 ext. 80895, c.schwarz@med.uni-tuebingen.de
Axel R Franz, MD, +49707129-0 ext. 83791, axel.franz@med.uni-tuebingen.de
About this study
Official title: Automatic Oxygen Control (SPOC) in Preterm Infants - Evaluation of a Revised Algorithm and Effect of Averaging Time of Pulse Oximetry Signal
Single-center, randomised controlled, cross-over clinical trial in preterm infants born at gestational age below 34+1/7 weeks receiving supplemental oxygen and respiratory support (continous positive airway pressure (CPAP) or non-invasive ventilation (NIV) or invasive ventilation (IV)). Routine manual control (RMC) of the fraction of inspired oxygen (FiO2) will be tested against RMC supported by automatic control (SPOC) with "old"-algorithm and RMC supported by CLAC with "new"-algorithm.
The first primary hypothesis is, that the use of the "new" algorithm results in more time within arterial oxygen saturation (SpO2) target range compared to RMC only. The a-priori subordinate hypothesis is, that the new algorithm results in more time within SpO2 target range compared to SPOCold.
The second primary hypothesis is, that the use of 2 seconds averaging time of the SpO2 Signal results in more time within arterial oxygen saturation (SpO2) target range compared to the use of 8 seconds averaging interval of the SpO2 signal.
Read the detailed description
BACKGROUND AND OBJECTIVE In preterm infants receiving supplemental oxygen, routine manual control (RMC) of the fraction of inspired oxygen (FiO2) is often difficult and time consuming. The investigators developed a system for closed-loop automatic control (SPOC) of the FiO2. The objective of this study is to test a revised, "new" algorithm with 3 adaptions against the former "old" algorithm and against RMC. The 3 adaptions are:
- Faster re-adjustment to baseline-FiO2 (baseline FiO2: mean FiO2 during the previous 5min)
- Delayed reduction of FiO2 below baseline FiO2
- Maximum FiO2 adjustable by user
The first primary hypothesis is, that the application of SPOCnew in addition to RMC results in more time within arterial oxygen saturation (SpO2) target range compared to RMC only. The a-priori subordinate hypothesis is, that the revised algorithm is more effective as the old algorithm to maintain the SpO2 in the target range.
The second primary hypothesis is, that the shortening of averaging time used for the SpO2 Signal from 8 seconds to 2 seconds results in more time within SpO2 target range for both, SPOCnew and SPOCold.
Further hypotheses for exploratory testing are, that the SPOC new algorithm will achieve a lower proportion of time with SpO2 above and below the target range, hyper- and hypoxia and an improved stability of cerebral oxygenation (measured as rcStO2 and rcFtO2E determined by Near-infrared spectroscopy) compared with SPOCold and RMC. Reduction of staff workload (estimated by number of manual adjustments per hour) by SPOC. Validation of a clinical scoring tool to monitor severity of apnea of prematurity.
STUDY DESIGN The Study is designed as a single-center, randomized controlled, cross-over clinical trial in preterm infants receiving mechanical ventilation or nasal continuous positive airway pressure or non-invasive ventilation and supplemental oxygen (FiO2 above 0.21). Within a 30-hour period the investigators will compare 6 hours of RMC with 12-hour periods of RMC supported by SPOCnew algorithm or SPOCold algorithm, respectively. During intervals with SPOC control the SpO2 Signal averaging time will be 2 second or 8seconds , respectively, for 6 hours each.
- Being tested
- SPOCnew, 8s SpO2 averaging, SPOCold, 2s SpO2 averaging
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPOCnewDevice
SPOC is an automated, algorithm based adjustment of the fraction of inspired oxygen in relation to arterial saturation (SPO2). The revised "new" algorithm is turned on.
8s SpO2 averagingDevice
The arterial saturation (SPO2) will be averaged over 8s.
SPOColdDevice
SPOC is an automated, algorithm based adjustment of the fraction of inspired oxygen in relation to arterial saturation (SPO2). The former "old" algorithm is turned on.
2s SpO2 averagingDevice
The arterial saturation (SPO2) will be averaged over 2s.
| Study group | Role | What they receive |
|---|---|---|
| RMC only | No intervention | routine manual control (RMC) of the fraction of inspired oxygen (FIO2) |
| SPOCnew and 2s SpO2 averaging | Experimental | routine manual control (RMC) + automatic oxygen control (SPOC) with "new" algorithm of the fraction of inspired oxygen (FIO2).
The SpO2 signal averaging time is 2s. Receives: Device: SPOCnew; Device: 2s SpO2 averaging |
| SPOCnew and 8s SpO2 averaging | Experimental | routine manual control (RMC) + automatic oxygen control (SPOC) with "new" algorithm of the fraction of inspired oxygen (FIO2).
The SpO2 signal averaging time is 8s. Receives: Device: SPOCnew; Device: 8s SpO2 averaging |
| SPOCold and 2s SpO2 averaging | Active comparator | routine manual control (RMC) + automatic oxygen control (SPOC) with "old" algorithm of the fraction of inspired oxygen (FIO2).
The SpO2 signal averaging time is 2s. Receives: Device: SPOCold; Device: 2s SpO2 averaging |
| SPOCold and 8s SpO2 averaging | Active comparator | routine manual control (RMC) + automatic oxygen control (SPOC) with "old" algorithm of the fraction of inspired oxygen (FIO2).
The SpO2 signal averaging time is 8s. Receives: Device: 8s SpO2 averaging; Device: SPOCold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of time with SpO2 within target range
Comparison of proportion of time with SpO2 within target range and time above target range if no supplemental oxygen was administered at that time and within the preceding 30sec between the five treatment modalities
Measured: 30 hours
Secondary outcomes (6)
Proportion of Time with SpO2 above target range
Comparison of proportion of time with SpO2 above target range if supplemental oxygen was administered at that time or within the preceding 30sec .
Measured: 30 hours
Proportion of Time with SpO2 below target range
Comparison of proportion of time with SpO2 below target range.
Measured: 30 hours
Proportion of Time with Hypoxia
Comparison of proportion of time with SpO2 below 80%.
Measured: 30 hours
Proportion of Time with Hyperoxia
Comparison of proportion of time with SpO2 above 97% if supplemental oxygen was administered at that time or at anytime during the previous 30 seconds.
Measured: 30 hours
Stability of cerebral oxygenation
"Area under the curve" of cerebral tissue saturation or fraction of tissue oxygen extraction outside of the infants Median +- 5% or outside of the "safe" interval of 55-80% rcStO2.
Measured: 30 hours
Severe hypoxemic episodes
Rate of episodes with SpO2 <80% for at least 60seconds
Measured: 30 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start3 Aug 2018
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infantile Respiratory Distress SyndromeStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Fritz Stephan GmbH
- Responsible party
- Sponsor
- Investigators
- Christoph E Schwarz, MD, Principal investigator, University of Tubingen, University Hospital, Dept. Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785899
- Sponsor's protocol ID
- optimalSPOC
- Acronym
- optimalSPOC
- Status last verified
- Aug 2018
- First submitted
- 20 Dec 2018
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Langanky LO, Kreutzer KB, Poets CF, Franz AR, Schwarz CE. Pulse oximetry signal loss during hypoxic episodes in preterm infants receiving automated oxygen control. Eur J Pediatr. 2024 Jul;183(7):2865-2869. doi: 10.1007/s00431-024-05549-9. Epub 2024 Apr 9.
PubMed 38592485Schwarz CE, Kreutzer KB, Langanky L, Wolf NS, Braun W, O'Sullivan MP, Poets CF, Franz AR. Randomised crossover trial comparing algorithms and averaging times for automatic oxygen control in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2022 Jul;107(4):425-430. doi: 10.1136/archdischild-2021-322096. Epub 2021 Nov 24.
PubMed 34819347
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Oxygen Control (SPOC) in Preterm Infants - Evaluation of a Revised Algorithm and Effect of Averaging Time of Pulse Oximetry Signal
- ClinicalTrials.gov ID
- NCT03785899
- Acronym / sponsor ID
- optimalSPOC / optimalSPOC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Fritz Stephan GmbH
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 24 Dec 2018 (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.
Single-center, randomised controlled, cross-over clinical trial in preterm infants born at gestational age below 34+1/7 weeks receiving supplemental oxygen and respiratory support (continous positive airway pressure (CPAP) or non-invasive ventilation (NIV) or invasive ventilation (IV)). Routine manual control (RMC) of the fraction of inspired oxygen (FiO2) will be tested against RMC supported by automatic control (SPOC) with "old"-algorithm and RMC supported by CLAC with "new"-algorithm.
The first primary hypothesis is, that the use of the "new" algorithm results in more time within arterial oxygen saturation (SpO2) target range compared to RMC only. The a-priori subordinate hypothesis is, that the new algorithm results in more time within SpO2 target range compared to SPOCold.
The second primary hypothesis is, that the use of 2 seconds averaging time of the SpO2 Signal results in more time within arterial oxygen saturation (SpO2) target range compared to the use of 8 seconds averaging interval of the SpO2 signal.
Detailed description
BACKGROUND AND OBJECTIVE In preterm infants receiving supplemental oxygen, routine manual control (RMC) of the fraction of inspired oxygen (FiO2) is often difficult and time consuming. The investigators developed a system for closed-loop automatic control (SPOC) of the FiO2. The objective of this study is to test a revised, "new" algorithm with 3 adaptions against the former "old" algorithm and against RMC. The 3 adaptions are:
- Faster re-adjustment to baseline-FiO2 (baseline FiO2: mean FiO2 during the previous 5min)
- Delayed reduction of FiO2 below baseline FiO2
- Maximum FiO2 adjustable by user
The first primary hypothesis is, that the application of SPOCnew in addition to RMC results in more time within arterial oxygen saturation (SpO2) target range compared to RMC only. The a-priori subordinate hypothesis is, that the revised algorithm is more effective as the old algorithm to maintain the SpO2 in the target range.
The second primary hypothesis is, that the shortening of averaging time used for the SpO2 Signal from 8 seconds to 2 seconds results in more time within SpO2 target range for both, SPOCnew and SPOCold.
Further hypotheses for exploratory testing are, that the SPOC new algorithm will achieve a lower proportion of time with SpO2 above and below the target range, hyper- and hypoxia and an improved stability of cerebral oxygenation (measured as rcStO2 and rcFtO2E determined by Near-infrared spectroscopy) compared with SPOCold and RMC. Reduction of staff workload (estimated by number of manual adjustments per hour) by SPOC. Validation of a clinical scoring tool to monitor severity of apnea of prematurity.
STUDY DESIGN The Study is designed as a single-center, randomized controlled, cross-over clinical trial in preterm infants receiving mechanical ventilation or nasal continuous positive airway pressure or non-invasive ventilation and supplemental oxygen (FiO2 above 0.21). Within a 30-hour period the investigators will compare 6 hours of RMC with 12-hour periods of RMC supported by SPOCnew algorithm or SPOCold algorithm, respectively. During intervals with SPOC control the SpO2 Signal averaging time will be 2 second or 8seconds , respectively, for 6 hours each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| RMC only | No intervention | –routine manual control (RMC) of the fraction of inspired oxygen (FIO2) |
| SPOCnew and 2s SpO2 averaging | Experimental | Device: SPOCnew, Device: 2s SpO2 averagingroutine manual control (RMC) + automatic oxygen control (SPOC) with "new" algorithm of the fraction of inspired oxygen (FIO2). The SpO2 signal averaging time is 2s. |
| SPOCnew and 8s SpO2 averaging | Experimental | Device: SPOCnew, Device: 8s SpO2 averagingroutine manual control (RMC) + automatic oxygen control (SPOC) with "new" algorithm of the fraction of inspired oxygen (FIO2). The SpO2 signal averaging time is 8s. |
| SPOCold and 2s SpO2 averaging | Active comparator | Device: SPOCold, Device: 2s SpO2 averagingroutine manual control (RMC) + automatic oxygen control (SPOC) with "old" algorithm of the fraction of inspired oxygen (FIO2). The SpO2 signal averaging time is 2s. |
| SPOCold and 8s SpO2 averaging | Active comparator | Device: 8s SpO2 averaging, Device: SPOColdroutine manual control (RMC) + automatic oxygen control (SPOC) with "old" algorithm of the fraction of inspired oxygen (FIO2). The SpO2 signal averaging time is 8s. |
Who may qualify
- Ages
- Up to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- gestational age at birth <34+1/7weeks and
- invasive mechanical ventilation OR noninvasive ventilation OR continous positive airway pressure support and
- Fraction of inspired oxygen above 0.21 before inclusion and
- more than 2 hypoxaemic events (arterial oxygen saturation below 80%) within 8 hours before inclusion and
- parental written informed consent
Key exclusion criteria (5 listed)
- congenital pulmonary anomalies
- congenital heart defects influencing SpO2 (i.e. cyanotic heart defects)
- right-to -left shunt through a PDA
- Severe neonatal complications during study period (sepsis, necrotising enterocolitis)
- diaphragmatic hernia or other diaphragmatic disorders
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 |
|---|---|---|
| SPOCnewSPOC is an automated, algorithm based adjustment of the fraction of inspired oxygen in relation to arterial saturation (SPO2). The revised "new" algorithm is turned on. | Device | SPOCnew and 2s SpO2 averaging, SPOCnew and 8s SpO2 averaging |
| 8s SpO2 averagingThe arterial saturation (SPO2) will be averaged over 8s. | Device | SPOCnew and 8s SpO2 averaging, SPOCold and 8s SpO2 averaging |
| SPOColdSPOC is an automated, algorithm based adjustment of the fraction of inspired oxygen in relation to arterial saturation (SPO2). The former "old" algorithm is turned on. | Device | SPOCold and 2s SpO2 averaging, SPOCold and 8s SpO2 averaging |
| 2s SpO2 averagingThe arterial saturation (SPO2) will be averaged over 2s. | Device | SPOCnew and 2s SpO2 averaging, SPOCold and 2s SpO2 averaging |
Primary outcome
Proportion of time with SpO2 within target range
Time frame: 30 hours
Comparison of proportion of time with SpO2 within target range and time above target range if no supplemental oxygen was administered at that time and within the preceding 30sec between the five treatment modalities
6 secondary outcomes
Proportion of Time with SpO2 above target range
Time frame: 30 hours
Proportion of Time with SpO2 below target range
Time frame: 30 hours
Proportion of Time with Hypoxia
Time frame: 30 hours
Proportion of Time with Hyperoxia
Time frame: 30 hours
Stability of cerebral oxygenation
Time frame: 30 hours
Severe hypoxemic episodes
Time frame: 30 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Derived from this study: PubMed 38592485Langanky LO, Kreutzer KB, Poets CF, Franz AR, Schwarz CE. Pulse oximetry signal loss during hypoxic episodes in preterm infants receiving automated oxygen control. Eur J Pediatr. 2024 Jul;183(7):2865-2869. doi: 10.1007/s00431-024-05549-9. Epub 2024 Apr 9.
- Derived from this study: PubMed 34819347Schwarz CE, Kreutzer KB, Langanky L, Wolf NS, Braun W, O'Sullivan MP, Poets CF, Franz AR. Randomised crossover trial comparing algorithms and averaging times for automatic oxygen control in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2022 Jul;107(4):425-430. doi: 10.1136/archdischild-2021-322096. Epub 2021 Nov 24.
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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.
Christoph E Schwarz, MD principal investigator
University of Tubingen, University Hospital, Dept. Neonatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPOCnew, 8s SpO2 averaging and SPOCold in people with Infantile Respiratory Distress Syndrome and Ventilator Lung; Newborn, 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 5 inclusion and 5 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 4 Jan 2019. 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 Christoph E Schwarz, MD (+49707129-0 ext. 84742, c.schwarz@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of time with SpO2 within target range (time frame: 30 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 NCT03785899, which also lists 2 linked publications.
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 4 Jan 2019.