Pre-TermNCT05017727
Closed-loop Oxygen Control in Ventilated Infants Born at or Near Term
An observational study of Pre-Term and Respiratory Disease, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
Ventilated neonates frequently require supplementary oxygen to allow for adequate oxygen delivery to the tissues and normal cell metabolism. Oxygen treatment should be monitored carefully as both excessive and inadequate dosing can have detrimental effects for the infants. Read more about this study
- Who is it for?
- Ages 34 weeks and older
- Conditions the study is for
- Pre-Term, Respiratory Disease
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Oct 2021to 17 Jan 2023
- Phase
- Observational
- 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 34 weeks and older
- All sexes
- Child, Adult, Older adult
Study population: This will be a randomised controlled crossover study. We aim to recruit a minimum of 31 ventilated infants born at 34 weeks completed gestation and above and admitted to the Neonatal Intensive Care Unit at our hospital over one year.
Who may be able to join
- Infants born at 34 weeks completed gestation and above requiring mechanical ventilation and admitted to King's NICU
- Any gender, ethnicity or other comorbidities
Who cannot join
- Preterm infants less than 34 weeks gestation
- Infants with cyanotic congenital heart disease
- Infants undergoing planned procedures or surgery during the monitoring period
- Infants on high frequency oscillatory ventilation (HFOV)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital NHS Foundation Trust
London, SE5 0BD
About this study
Official title: Does Closed-loop Automated Oxygen Control During Mechanical Ventilation Reduce Hypoxic Events? A Randomised Controlled Crossover Study in Ventilated Infants
Ventilated neonates frequently require supplementary oxygen to allow for adequate oxygen delivery to the tissues and normal cell metabolism. Oxygen treatment should be monitored carefully as both excessive and inadequate dosing can have detrimental effects for the infants. Hypoxia (giving too little oxygen) increases mortality and later disability whereas hyperoxia (giving too much oxygen) increases the risk of complications such as retinopathy of prematurity and lung disease. Although very preterm and low birth weight infants represent the majority of ventilated neonates, more mature infants may also require mechanical ventilation at birth and provision of supplementary oxygen. Therefore, they may suffer from complications related to hypoxia or hyperoxia. Hence, their oxygen saturation levels and the amount of the inspired oxygen concentration provided should be continuously monitored.
Oxygen control is traditionally monitored and adjusted manually by the nurse looking after the infant. Closed-loop automated oxygen control (CLAC) is a more recent approach that involves the use of a computer software incorporated into the ventilator. The software uses an algorithm that automatically adjusts the amount of inspired oxygen to maintain oxygen saturation levels in a target range. Evidence suggests that CLAC increases the time spent in the desired oxygen target range, decreases the duration of hypoxia and hyperoxia and reduces the number of manual adjustments required by clinical staff. However previous studies have been limited to very small infants. With this study the investigators aim to evaluate the effectiveness of CLAC in ventilated infants born at 34 weeks gestation and beyond. The achievement of oxygen saturation targets and the number of manual adjustments required will be compared between periods of CLAC and manual control in a cohort of patients that has not been included in previous studies and could also benefit from the intervention. The investigators will also evaluate if CLAC reduces investigations performed to ventilated babies(blood gases, X-rays).
Read the detailed description
This will be a randomised controlled crossover study. The investigators aim to recruit a minimum of 31 ventilated infants born at 34 weeks completed gestation and above and admitted to the Neonatal Intensive Care Unit at King's College Hospital over one year. Participants will undergo two monitoring periods each lasting 12 hours (8:00am-20:00pm): one with standard manually controlled oxygen and one with closed-loop automated oxygen control. Randomisation will be used to determine whether the first period will be manual or closed-loop automated oxygen control. The two monitoring periods will take place on two consecutive days to allow for clinical conditions to remain as stable as possible.
Infants with known congenital cyanotic heart disease will be excluded from the study as well as those undergoing surgery or any planned procedures during the monitoring period.
Informed written consent will be requested from the parents or legal guardians of the infants and the attending Neonatal Consultant will be requested to verbally assent to the study.
Randomisation of eligible infants whose parents consent to the study will be performed using an online randomisation generator to determine whether the first monitoring period will be manual adjustment or closed-loop automated oxygen control ("intervention" period).
Patients will be ventilated using SLE6000 ventilators. Ventilation settings will be manually adjusted by the clinical team as per unit's protocol. During the intervention period, in addition to standard care, infants will be also connected to the OxyGenie closed-loop oxygen saturation monitoring software (SLE). This software uses oxygen saturations from the SpO2 probe attached to the neonate, fed into an algorithm, to automatically adjust the percentage of inspired oxygen to maintain oxygen saturations within the target range. Manual adjustments including the percentage of FiO2 will be allowed at any point during the study including the period of automated oxygen control if deemed appropriate by the clinical team. Oxygen saturation levels and automatic adjustments to the inspired oxygen concentration will be captured by the ventilator software. Manual adjustments will be recorded during both monitoring periods. In addition to data collected from the ventilator, medical notes will be reviewed to determine any adverse events or clinical interventions to participants during the study. The number of blood gas samples taken and chest radiographs performed during each monitoring period will also be recorded.
- Conditions
- Pre-Term, Respiratory Disease
- Being tested
- Closed-loop automated oxygen control with Oxygenie Auto-O2 software (SLE6000)
- Medical subject headings
- Premature Birth, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop automated oxygen control with Oxygenie Auto-O2 software (SLE6000)Device
The 'Oxygenie' is a closed loop automated oxygen control system that has been incorporated into a software module for the SLE6000 infant ventilators. This software control system allows targeting SpO2 values by controlling FiO2.
What is being measured
The primary outcome is the main question the study is designed to answer.
The decrease in the percentage of time spent in extremes of hypoxia
That will be assessed by evaluating the infant's respiratory status.
Measured: Over 24 hours
Secondary outcomes (3)
The increase in the percentage of time spent within target oxygen saturation ranges (94-98%)
This will be assessed by evaluating the infant's respiratory status.
Measured: Over 24 hours
The reduction in the number of manual adjustments required to the inspired oxygen concentration
That will be assessed by reviewing the infant's medical records
Measured: Over 24 hours
The reduction in the number of blood gases and chest radiographs
That will be assessed by reviewing the infant's medical records
Measured: Over 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start5 Oct 2021
- Primary completion17 Jan 2023
- Study completion17 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Pre-TermStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Anne Greenough, Professor, Principal investigator, King's College Hospital/ King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017727
- Sponsor's protocol ID
- 298164
- Status last verified
- Sep 2023
- First submitted
- 17 Aug 2021
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Consortium on Safe Labor; Hibbard JU, Wilkins I, Sun L, Gregory K, Haberman S, Hoffman M, Kominiarek MA, Reddy U, Bailit J, Branch DW, Burkman R, Gonzalez Quintero VH, Hatjis CG, Landy H, Ramirez M, VanVeldhuisen P, Troendle J, Zhang J. Respiratory morbidity in late preterm births. JAMA. 2010 Jul 28;304(4):419-25. doi: 10.1001/jama.2010.1015.
PubMed 20664042Colin AA, McEvoy C, Castile RG. Respiratory morbidity and lung function in preterm infants of 32 to 36 weeks' gestational age. Pediatrics. 2010 Jul;126(1):115-28. doi: 10.1542/peds.2009-1381. Epub 2010 Jun 7.
PubMed 20530073Pike KC, Lucas JS. Respiratory consequences of late preterm birth. Paediatr Respir Rev. 2015 Jun;16(3):182-8. doi: 10.1016/j.prrv.2014.12.001. Epub 2014 Dec 8.
PubMed 25554628Clark RH. The epidemiology of respiratory failure in neonates born at an estimated gestational age of 34 weeks or more. J Perinatol. 2005 Apr;25(4):251-7. doi: 10.1038/sj.jp.7211242.
PubMed 15605071Gouyon JB, Ribakovsky C, Ferdynus C, Quantin C, Sagot P, Gouyon B; Burgundy Perinatal Network. Severe respiratory disorders in term neonates. Paediatr Perinat Epidemiol. 2008 Jan;22(1):22-30. doi: 10.1111/j.1365-3016.2007.00875.x.
PubMed 18173781Ramadan G, Paul N, Morton M, Peacock JL, Greenough A. Outcome of ventilated infants born at term without major congenital abnormalities. Eur J Pediatr. 2012 Feb;171(2):331-6. doi: 10.1007/s00431-011-1549-8. Epub 2011 Aug 11.
PubMed 21833494Angus DC, Linde-Zwirble WT, Clermont G, Griffin MF, Clark RH. Epidemiology of neonatal respiratory failure in the United States: projections from California and New York. Am J Respir Crit Care Med. 2001 Oct 1;164(7):1154-60. doi: 10.1164/ajrccm.164.7.2012126.
PubMed 11673202Walsh BK, Smallwood CD. Pediatric Oxygen Therapy: A Review and Update. Respir Care. 2017 Jun;62(6):645-661. doi: 10.4187/respcare.05245.
PubMed 28546370Baba L, McGrath JM. Oxygen free radicals: effects in the newborn period. Adv Neonatal Care. 2008 Oct;8(5):256-64. doi: 10.1097/01.ANC.0000338015.25911.8a.
PubMed 18827514Askie LM, Henderson-Smart DJ, Irwig L, Simpson JM. Oxygen-saturation targets and outcomes in extremely preterm infants. N Engl J Med. 2003 Sep 4;349(10):959-67. doi: 10.1056/NEJMoa023080.
PubMed 12954744Supplemental Therapeutic Oxygen for Prethreshold Retinopathy Of Prematurity (STOP-ROP), a randomized, controlled trial. I: primary outcomes. Pediatrics. 2000 Feb;105(2):295-310. doi: 10.1542/peds.105.2.295.
PubMed 10654946BOOST-II Australia and United Kingdom Collaborative Groups; Tarnow-Mordi W, Stenson B, Kirby A, Juszczak E, Donoghoe M, Deshpande S, Morley C, King A, Doyle LW, Fleck BW, Davis PG, Halliday HL, Hague W, Cairns P, Darlow BA, Fielder AR, Gebski V, Marlow N, Simmer K, Tin W, Ghadge A, Williams C, Keech A, Wardle SP, Kecskes Z, Kluckow M, Gole G, Evans N, Malcolm G, Luig M, Wright I, Stack J, Tan K, Pritchard M, Gray PH, Morris S, Headley B, Dargaville P, Simes RJ, Brocklehurst P. Outcomes of Two Trials of Oxygen-Saturation Targets in Preterm Infants. N Engl J Med. 2016 Feb 25;374(8):749-60. doi: 10.1056/NEJMoa1514212. Epub 2016 Feb 10.
PubMed 26863265Saugstad OD, Aune D. In search of the optimal oxygen saturation for extremely low birth weight infants: a systematic review and meta-analysis. Neonatology. 2011;100(1):1-8. doi: 10.1159/000322001. Epub 2010 Dec 9.
PubMed 21150224Williams LZJ, McNamara D, Alsweiler JM. Intermittent Hypoxemia in Infants Born Late Preterm: A Prospective Cohort Observational Study. J Pediatr. 2019 Jan;204:89-95.e1. doi: 10.1016/j.jpeds.2018.08.048. Epub 2018 Oct 1.
PubMed 30287066Lakshminrusimha S, Konduri GG, Steinhorn RH. Considerations in the management of hypoxemic respiratory failure and persistent pulmonary hypertension in term and late preterm neonates. J Perinatol. 2016 Jun;36 Suppl 2:S12-9. doi: 10.1038/jp.2016.44.
PubMed 27225960
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Closed-loop Automated Oxygen Control During Mechanical Ventilation Reduce Hypoxic Events? A Randomised Controlled Crossover Study in Ventilated Infants
- ClinicalTrials.gov ID
- NCT05017727
- Acronym / sponsor ID
- 298164
- Conditions
- Pre-Term, Respiratory Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 24 Aug 2021 (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.
Ventilated neonates frequently require supplementary oxygen to allow for adequate oxygen delivery to the tissues and normal cell metabolism. Oxygen treatment should be monitored carefully as both excessive and inadequate dosing can have detrimental effects for the infants. Hypoxia (giving too little oxygen) increases mortality and later disability whereas hyperoxia (giving too much oxygen) increases the risk of complications such as retinopathy of prematurity and lung disease. Although very preterm and low birth weight infants represent the majority of ventilated neonates, more mature infants may also require mechanical ventilation at birth and provision of supplementary oxygen. Therefore, they may suffer from complications related to hypoxia or hyperoxia. Hence, their oxygen saturation levels and the amount of the inspired oxygen concentration provided should be continuously monitored.
Oxygen control is traditionally monitored and adjusted manually by the nurse looking after the infant. Closed-loop automated oxygen control (CLAC) is a more recent approach that involves the use of a computer software incorporated into the ventilator. The software uses an algorithm that automatically adjusts the amount of inspired oxygen to maintain oxygen saturation levels in a target range. Evidence suggests that CLAC increases the time spent in the desired oxygen target range, decreases the duration of hypoxia and hyperoxia and reduces the number of manual adjustments required by clinical staff. However previous studies have been limited to very small infants. With this study the investigators aim to evaluate the effectiveness of CLAC in ventilated infants born at 34 weeks gestation and beyond. The achievement of oxygen saturation targets and the number of manual adjustments required will be compared between periods of CLAC and manual control in a cohort of patients that has not been included in previous studies and could also benefit from the intervention. The investigators will also evaluate if CLAC reduces investigations performed to ventilated babies(blood gases, X-rays).
Detailed description
This will be a randomised controlled crossover study. The investigators aim to recruit a minimum of 31 ventilated infants born at 34 weeks completed gestation and above and admitted to the Neonatal Intensive Care Unit at King's College Hospital over one year. Participants will undergo two monitoring periods each lasting 12 hours (8:00am-20:00pm): one with standard manually controlled oxygen and one with closed-loop automated oxygen control. Randomisation will be used to determine whether the first period will be manual or closed-loop automated oxygen control. The two monitoring periods will take place on two consecutive days to allow for clinical conditions to remain as stable as possible.
Infants with known congenital cyanotic heart disease will be excluded from the study as well as those undergoing surgery or any planned procedures during the monitoring period.
Informed written consent will be requested from the parents or legal guardians of the infants and the attending Neonatal Consultant will be requested to verbally assent to the study.
Randomisation of eligible infants whose parents consent to the study will be performed using an online randomisation generator to determine whether the first monitoring period will be manual adjustment or closed-loop automated oxygen control ("intervention" period).
Patients will be ventilated using SLE6000 ventilators. Ventilation settings will be manually adjusted by the clinical team as per unit's protocol. During the intervention period, in addition to standard care, infants will be also connected to the OxyGenie closed-loop oxygen saturation monitoring software (SLE). This software uses oxygen saturations from the SpO2 probe attached to the neonate, fed into an algorithm, to automatically adjust the percentage of inspired oxygen to maintain oxygen saturations within the target range. Manual adjustments including the percentage of FiO2 will be allowed at any point during the study including the period of automated oxygen control if deemed appropriate by the clinical team. Oxygen saturation levels and automatic adjustments to the inspired oxygen concentration will be captured by the ventilator software. Manual adjustments will be recorded during both monitoring periods. In addition to data collected from the ventilator, medical notes will be reviewed to determine any adverse events or clinical interventions to participants during the study. The number of blood gas samples taken and chest radiographs performed during each monitoring period will also be recorded.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 34 weeks and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- This will be a randomised controlled crossover study. We aim to recruit a minimum of 31 ventilated infants born at 34 weeks completed gestation and above and admitted to the Neonatal Intensive Care Unit at our hospital over one year.
Key inclusion criteria (2 listed)
- Infants born at 34 weeks completed gestation and above requiring mechanical ventilation and admitted to King's NICU
- Any gender, ethnicity or other comorbidities
Key exclusion criteria (4 listed)
- Preterm infants less than 34 weeks gestation
- Infants with cyanotic congenital heart disease
- Infants undergoing planned procedures or surgery during the monitoring period
- Infants on high frequency oscillatory ventilation (HFOV)
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 |
|---|---|---|
| Closed-loop automated oxygen control with Oxygenie Auto-O2 software (SLE6000)The 'Oxygenie' is a closed loop automated oxygen control system that has been incorporated into a software module for the SLE6000 infant ventilators. This software control system allows targeting SpO2 values by controlling FiO2. | Device | – |
Primary outcome
The decrease in the percentage of time spent in extremes of hypoxia
Time frame: Over 24 hours
That will be assessed by evaluating the infant's respiratory status.
3 secondary outcomes
The increase in the percentage of time spent within target oxygen saturation ranges (94-98%)
Time frame: Over 24 hours
The reduction in the number of manual adjustments required to the inspired oxygen concentration
Time frame: Over 24 hours
The reduction in the number of blood gases and chest radiographs
Time frame: Over 24 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 6 Sep 2023.
- Background: PubMed 20664042Consortium on Safe Labor; Hibbard JU, Wilkins I, Sun L, Gregory K, Haberman S, Hoffman M, Kominiarek MA, Reddy U, Bailit J, Branch DW, Burkman R, Gonzalez Quintero VH, Hatjis CG, Landy H, Ramirez M, VanVeldhuisen P, Troendle J, Zhang J. Respiratory morbidity in late preterm births. JAMA. 2010 Jul 28;304(4):419-25. doi: 10.1001/jama.2010.1015.
- Background: PubMed 20530073Colin AA, McEvoy C, Castile RG. Respiratory morbidity and lung function in preterm infants of 32 to 36 weeks' gestational age. Pediatrics. 2010 Jul;126(1):115-28. doi: 10.1542/peds.2009-1381. Epub 2010 Jun 7.
- Background: PubMed 25554628Pike KC, Lucas JS. Respiratory consequences of late preterm birth. Paediatr Respir Rev. 2015 Jun;16(3):182-8. doi: 10.1016/j.prrv.2014.12.001. Epub 2014 Dec 8.
- Background: PubMed 15605071Clark RH. The epidemiology of respiratory failure in neonates born at an estimated gestational age of 34 weeks or more. J Perinatol. 2005 Apr;25(4):251-7. doi: 10.1038/sj.jp.7211242.
- Background: PubMed 18173781Gouyon JB, Ribakovsky C, Ferdynus C, Quantin C, Sagot P, Gouyon B; Burgundy Perinatal Network. Severe respiratory disorders in term neonates. Paediatr Perinat Epidemiol. 2008 Jan;22(1):22-30. doi: 10.1111/j.1365-3016.2007.00875.x.
- Background: PubMed 21833494Ramadan G, Paul N, Morton M, Peacock JL, Greenough A. Outcome of ventilated infants born at term without major congenital abnormalities. Eur J Pediatr. 2012 Feb;171(2):331-6. doi: 10.1007/s00431-011-1549-8. Epub 2011 Aug 11.
- Background: PubMed 11673202Angus DC, Linde-Zwirble WT, Clermont G, Griffin MF, Clark RH. Epidemiology of neonatal respiratory failure in the United States: projections from California and New York. Am J Respir Crit Care Med. 2001 Oct 1;164(7):1154-60. doi: 10.1164/ajrccm.164.7.2012126.
- Background: PubMed 28546370Walsh BK, Smallwood CD. Pediatric Oxygen Therapy: A Review and Update. Respir Care. 2017 Jun;62(6):645-661. doi: 10.4187/respcare.05245.
- Background: PubMed 18827514Baba L, McGrath JM. Oxygen free radicals: effects in the newborn period. Adv Neonatal Care. 2008 Oct;8(5):256-64. doi: 10.1097/01.ANC.0000338015.25911.8a.
- Background: PubMed 12954744Askie LM, Henderson-Smart DJ, Irwig L, Simpson JM. Oxygen-saturation targets and outcomes in extremely preterm infants. N Engl J Med. 2003 Sep 4;349(10):959-67. doi: 10.1056/NEJMoa023080.
- Background: PubMed 10654946Supplemental Therapeutic Oxygen for Prethreshold Retinopathy Of Prematurity (STOP-ROP), a randomized, controlled trial. I: primary outcomes. Pediatrics. 2000 Feb;105(2):295-310. doi: 10.1542/peds.105.2.295.
- Background: PubMed 26863265BOOST-II Australia and United Kingdom Collaborative Groups; Tarnow-Mordi W, Stenson B, Kirby A, Juszczak E, Donoghoe M, Deshpande S, Morley C, King A, Doyle LW, Fleck BW, Davis PG, Halliday HL, Hague W, Cairns P, Darlow BA, Fielder AR, Gebski V, Marlow N, Simmer K, Tin W, Ghadge A, Williams C, Keech A, Wardle SP, Kecskes Z, Kluckow M, Gole G, Evans N, Malcolm G, Luig M, Wright I, Stack J, Tan K, Pritchard M, Gray PH, Morris S, Headley B, Dargaville P, Simes RJ, Brocklehurst P. Outcomes of Two Trials of Oxygen-Saturation Targets in Preterm Infants. N Engl J Med. 2016 Feb 25;374(8):749-60. doi: 10.1056/NEJMoa1514212. Epub 2016 Feb 10.
- 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.
Anne Greenough, Professor principal investigator
King's College Hospital/ King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Term and Respiratory Disease, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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 2 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 6 Sep 2023. 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 United Kingdom. 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 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?
The decrease in the percentage of time spent in extremes of hypoxia (time frame: Over 24 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 NCT05017727, which also lists 27 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 6 Sep 2023; AzTrials last refreshed its copy on 30 Oct 2026.