Infant, Premature, DiseasesNCT05030337
Optimising Ventilation in Preterms With Closed-loop Oxygen Control
A study of Infant, Premature, Diseases and Airway Morbidity, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
Many premature infants require respiratory support in the newborn period. Mechanical ventilation although life-saving is linked to complications for the lungs and other organs and its duration should be kept to a minimum. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infant, Premature, Diseases, Airway Morbidity, Mechanical Ventilation Complication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Sep 2021to Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preterm infants less than 31 weeks completed gestation at birth requiring mechanical ventilation and admitted to King's NICU in the first 48 hours after birth
Who cannot join
- Preterm infants above 31 weeks completed gestation or term born infants
- Infants with major congenital abnormalities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Theodore Dassios, Consultant Neonatologist contact
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Ourania Kaltsogianni, ourania.kaltsogianni@nhs.net
About this study
Official title: Does Closed-loop Automated Oxygen Control Reduce the Duration of Mechanical Ventilation? A Randomised Controlled Trial in Ventilated Preterm Infants
Many premature infants require respiratory support in the newborn period. Mechanical ventilation although life-saving is linked to complications for the lungs and other organs and its duration should be kept to a minimum. The use of supplemental oxygen may also increase the risk of comorbidities such as retinopathy of prematurity. Therefore, oxygen saturation levels and the amount of inspired oxygen concentration provided should be continuously monitored.
Oxygen control can be performed manually or with the use of a computer software incorporated into the ventilator that is called 'closed loop automated oxygen control'(CLAC). 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 but there are no data to determine the effect on important clinical outcomes. A previous study has also demonstrated that CLAC reduces the inspired oxygen concentration more rapidly when compared to manual control. That could help infants come off the ventilator sooner.
With this study we want to compare the time preterm infants spend on the ventilator when we use the software to automatically monitor their oxygen levels with those infants whose oxygen is adjusted manually by the clinical team. That could help us understand if the use of automated oxygen control reduces the duration of mechanical ventilation and subsequently the complications related to it.
Read the detailed description
This will be a randomised controlled trial. The investigators aim to recruit a minimum of seventy premature ventilated infants born at less than 31 weeks gestation. Participants will be randomised to either closed-loop automated oxygen control or manually controlled oxygen from recruitment to successful extubation. The investigators will also record basic epidemiologic parameters and associated comorbidities that may impact on the duration of mechanical ventilation. Infants with known congenital anomalies will be excluded from the study.
Informed written consent will be requested from the parents or legal guardians of the infants and the attending Neonatal Consultant will be requested to assent to the study.
Eligible infants whose parents consent to the study will be enrolled within 48 hours of initiation of mechanical ventilation.
Randomisation will be performed using an online randomisation generator. Patients will be ventilated using SLE6000 ventilators. Ventilation settings will be manually adjusted by the clinical team as per unit's protocol. The intervention group, in addition to standard care 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 if deemed appropriate by the clinical team.
The nurse-to-patient ratio will be according to the unit's protocol that is determined on the patient's acuity.
Patients will be studied from enrolment until successful extubation. If an infant fails extubation and requires reintubation within 48 hours, he will be studied in his initial arm if less than 28 days old. Therefore, for those infants randomised at the intervention group CLAC will resume. Preterm infants that remain ventilated beyond day 28 of life will continue at their study arm (closed-loop automated oxygen control or manual oxygen control) till their first extubation attempt.
- Being tested
- Closed-loop automated oxygen control (Oxygenie, SLE 6000)
- Medical subject headings
- Infant, Premature, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop automated oxygen control (Oxygenie, SLE 6000)Device
The OxyGenie closed-loop oxygen saturation monitoring software (SLE) 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 if deemed appropriate by the clinical team.
| Study group | Role | What they receive |
|---|---|---|
| Manual oxygen control | No intervention | Standard ventilation with inspired oxygen concentration adjusted manually as per unit's protocol. |
| Closed-loop automated oxygen control | Other | Ventilation with Oxygenie software (closed-loop automated oxygen control system), adjusted by clinical staff as necessary Receives: Device: Closed-loop automated oxygen control (Oxygenie, SLE 6000) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of mechanical ventilation
The duration of mechanical ventilation will be measured in median (interquartile range) number of days of ventilation for participants in each group.
Measured: Through study completion, an average of 2 years
Secondary outcomes (5)
The percentage of time spent within target oxygen saturation range.
Target oxygen saturation range for our preterm population is 90-95% as per local guideline. The time spent in target range will be calculated as a percentage of the total time of monitoring.
Measured: Through study completion, an average of 2 years
Number of manual adjustments to the inspired oxygen concentration required by clinical staff.
The number of manual adjustment will be calculated by reviewing the infant's medical records.
Measured: Through study completion, an average of 2 years
Number of days on oxygen.
The number of days each participant will require supplementary oxygen to maintain oxygen saturation levels within target range.
Measured: Through study completion, an average of 2 years
Length of Intensive Care stay
The days each participant is admitted at the Neonatal Intensive Care
Measured: Through study completion, an average of 2 years
A diagnosis of bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age
The diagnosis of BPD will be calculated by reviewing the infant's medical records and respiratory status.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start5 Sep 2021
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Infant, Premature, DiseasesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participating infants will be randomised either to manual oxygen control or closed-loop automated oxygen control, adjusted by clinical staff as necessary.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
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
- NCT05030337
- Sponsor's protocol ID
- 297749
- Other IDs
- KCH21-111
- Status last verified
- Oct 2024
- First submitted
- 17 Aug 2021
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Greenough A. Long-term respiratory consequences of premature birth at less than 32 weeks of gestation. Early Hum Dev. 2013 Oct;89 Suppl 2:S25-7. doi: 10.1016/j.earlhumdev.2013.07.004. Epub 2013 Jul 30.
PubMed 23910576Di Fiore JM, Bloom JN, Orge F, Schutt A, Schluchter M, Cheruvu VK, Walsh M, Finer N, Martin RJ. A higher incidence of intermittent hypoxemic episodes is associated with severe retinopathy of prematurity. J Pediatr. 2010 Jul;157(1):69-73. doi: 10.1016/j.jpeds.2010.01.046. Epub 2010 Mar 20.
PubMed 20304417Hagadorn JI, Furey AM, Nghiem TH, Schmid CH, Phelps DL, Pillers DA, Cole CH; AVIOx Study Group. Achieved versus intended pulse oximeter saturation in infants born less than 28 weeks' gestation: the AVIOx study. Pediatrics. 2006 Oct;118(4):1574-82. doi: 10.1542/peds.2005-0413.
PubMed 17015549Ford SP, Leick-Rude MK, Meinert KA, Anderson B, Sheehan MB, Haney BM, Leeks SR, Simon SD, Jackson JK. Overcoming barriers to oxygen saturation targeting. Pediatrics. 2006 Nov;118 Suppl 2:S177-86. doi: 10.1542/peds.2006-0913P.
PubMed 17079621Sink DW, Hope SA, Hagadorn JI. Nurse:patient ratio and achievement of oxygen saturation goals in premature infants. Arch Dis Child Fetal Neonatal Ed. 2011 Mar;96(2):F93-8. doi: 10.1136/adc.2009.178616. Epub 2010 Oct 30.
PubMed 21037284Sturrock S, Ambulkar H, Williams EE, Sweeney S, Bednarczuk NF, Dassios T, Greenough A. A randomised crossover trial of closed loop automated oxygen control in preterm, ventilated infants. Acta Paediatr. 2021 Mar;110(3):833-837. doi: 10.1111/apa.15585. Epub 2020 Oct 6.
PubMed 32969040Sturrock S, Williams E, Dassios T, Greenough A. Closed loop automated oxygen control in neonates-A review. Acta Paediatr. 2020 May;109(5):914-922. doi: 10.1111/apa.15089. Epub 2019 Nov 27.
PubMed 31715041Dani C. Automated control of inspired oxygen (FiO2 ) in preterm infants: Literature review. Pediatr Pulmonol. 2019 Mar;54(3):358-363. doi: 10.1002/ppul.24238. Epub 2019 Jan 10.
PubMed 30632296Hunt KA, Dassios T, Ali K, Greenough A. Prediction of bronchopulmonary dysplasia development. Arch Dis Child Fetal Neonatal Ed. 2018 Nov;103(6):F598-F599. doi: 10.1136/archdischild-2018-315343. Epub 2018 Jun 12. No abstract available.
PubMed 29895571Dimitriou G, Greenough A, Endo A, Cherian S, Rafferty GF. Prediction of extubation failure in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2002 Jan;86(1):F32-5. doi: 10.1136/fn.86.1.f32.
PubMed 11815545Vliegenthart RJS, van Kaam AH, Aarnoudse-Moens CSH, van Wassenaer AG, Onland W. Duration of mechanical ventilation and neurodevelopment in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2019 Nov;104(6):F631-F635. doi: 10.1136/archdischild-2018-315993. Epub 2019 Mar 20.
PubMed 30894396Kaltsogianni O, Dassios T, Jenkinson A, Jeffreys E, Ikeda K, Sugino M, Greenough A. Closed-loop automated oxygen control in preterm ventilated infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2026 Apr 17;111(3):F243-F248. doi: 10.1136/archdischild-2025-329022.
PubMed 41218846Kaltsogianni O, Dassios T, Greenough A. Does closed-loop automated oxygen control reduce the duration of mechanical ventilation? A randomised controlled trial in ventilated preterm infants. Trials. 2022 Apr 8;23(1):276. doi: 10.1186/s13063-022-06222-y.
PubMed 35395952
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Closed-loop Automated Oxygen Control Reduce the Duration of Mechanical Ventilation? A Randomised Controlled Trial in Ventilated Preterm Infants
- ClinicalTrials.gov ID
- NCT05030337
- Acronym / sponsor ID
- 297749
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 5 Sep 2021 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 1 Sep 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.
Many premature infants require respiratory support in the newborn period. Mechanical ventilation although life-saving is linked to complications for the lungs and other organs and its duration should be kept to a minimum. The use of supplemental oxygen may also increase the risk of comorbidities such as retinopathy of prematurity. Therefore, oxygen saturation levels and the amount of inspired oxygen concentration provided should be continuously monitored.
Oxygen control can be performed manually or with the use of a computer software incorporated into the ventilator that is called 'closed loop automated oxygen control'(CLAC). 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 but there are no data to determine the effect on important clinical outcomes. A previous study has also demonstrated that CLAC reduces the inspired oxygen concentration more rapidly when compared to manual control. That could help infants come off the ventilator sooner.
With this study we want to compare the time preterm infants spend on the ventilator when we use the software to automatically monitor their oxygen levels with those infants whose oxygen is adjusted manually by the clinical team. That could help us understand if the use of automated oxygen control reduces the duration of mechanical ventilation and subsequently the complications related to it.
Detailed description
This will be a randomised controlled trial. The investigators aim to recruit a minimum of seventy premature ventilated infants born at less than 31 weeks gestation. Participants will be randomised to either closed-loop automated oxygen control or manually controlled oxygen from recruitment to successful extubation. The investigators will also record basic epidemiologic parameters and associated comorbidities that may impact on the duration of mechanical ventilation. Infants with known congenital anomalies will be excluded from the study.
Informed written consent will be requested from the parents or legal guardians of the infants and the attending Neonatal Consultant will be requested to assent to the study.
Eligible infants whose parents consent to the study will be enrolled within 48 hours of initiation of mechanical ventilation.
Randomisation will be performed using an online randomisation generator. Patients will be ventilated using SLE6000 ventilators. Ventilation settings will be manually adjusted by the clinical team as per unit's protocol. The intervention group, in addition to standard care 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 if deemed appropriate by the clinical team.
The nurse-to-patient ratio will be according to the unit's protocol that is determined on the patient's acuity.
Patients will be studied from enrolment until successful extubation. If an infant fails extubation and requires reintubation within 48 hours, he will be studied in his initial arm if less than 28 days old. Therefore, for those infants randomised at the intervention group CLAC will resume. Preterm infants that remain ventilated beyond day 28 of life will continue at their study arm (closed-loop automated oxygen control or manual oxygen control) till their first extubation attempt.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participating infants will be randomised either to manual oxygen control or closed-loop automated oxygen control, adjusted by clinical staff as necessary.
| Arm | Type | Receives |
|---|---|---|
| Manual oxygen control | No intervention | –Standard ventilation with inspired oxygen concentration adjusted manually as per unit's protocol. |
| Closed-loop automated oxygen control | Other | Device: Closed-loop automated oxygen control (Oxygenie, SLE 6000)Ventilation with Oxygenie software (closed-loop automated oxygen control system), adjusted by clinical staff as necessary |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Preterm infants less than 31 weeks completed gestation at birth requiring mechanical ventilation and admitted to King's NICU in the first 48 hours after birth
Key exclusion criteria (2 listed)
- Preterm infants above 31 weeks completed gestation or term born infants
- Infants with major congenital abnormalities
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 (Oxygenie, SLE 6000)The OxyGenie closed-loop oxygen saturation monitoring software (SLE) 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 if deemed appropriate by the clinical team. | Device | Closed-loop automated oxygen control |
Primary outcome
The duration of mechanical ventilation
Time frame: Through study completion, an average of 2 years
The duration of mechanical ventilation will be measured in median (interquartile range) number of days of ventilation for participants in each group.
5 secondary outcomes
The percentage of time spent within target oxygen saturation range.
Time frame: Through study completion, an average of 2 years
Number of manual adjustments to the inspired oxygen concentration required by clinical staff.
Time frame: Through study completion, an average of 2 years
Number of days on oxygen.
Time frame: Through study completion, an average of 2 years
Length of Intensive Care stay
Time frame: Through study completion, an average of 2 years
A diagnosis of bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Background: PubMed 23910576Greenough A. Long-term respiratory consequences of premature birth at less than 32 weeks of gestation. Early Hum Dev. 2013 Oct;89 Suppl 2:S25-7. doi: 10.1016/j.earlhumdev.2013.07.004. Epub 2013 Jul 30.
- Background: PubMed 20304417Di Fiore JM, Bloom JN, Orge F, Schutt A, Schluchter M, Cheruvu VK, Walsh M, Finer N, Martin RJ. A higher incidence of intermittent hypoxemic episodes is associated with severe retinopathy of prematurity. J Pediatr. 2010 Jul;157(1):69-73. doi: 10.1016/j.jpeds.2010.01.046. Epub 2010 Mar 20.
- Background: PubMed 17015549Hagadorn JI, Furey AM, Nghiem TH, Schmid CH, Phelps DL, Pillers DA, Cole CH; AVIOx Study Group. Achieved versus intended pulse oximeter saturation in infants born less than 28 weeks' gestation: the AVIOx study. Pediatrics. 2006 Oct;118(4):1574-82. doi: 10.1542/peds.2005-0413.
- Background: PubMed 17079621Ford SP, Leick-Rude MK, Meinert KA, Anderson B, Sheehan MB, Haney BM, Leeks SR, Simon SD, Jackson JK. Overcoming barriers to oxygen saturation targeting. Pediatrics. 2006 Nov;118 Suppl 2:S177-86. doi: 10.1542/peds.2006-0913P.
- Background: PubMed 21037284Sink DW, Hope SA, Hagadorn JI. Nurse:patient ratio and achievement of oxygen saturation goals in premature infants. Arch Dis Child Fetal Neonatal Ed. 2011 Mar;96(2):F93-8. doi: 10.1136/adc.2009.178616. Epub 2010 Oct 30.
- Background: PubMed 32969040Sturrock S, Ambulkar H, Williams EE, Sweeney S, Bednarczuk NF, Dassios T, Greenough A. A randomised crossover trial of closed loop automated oxygen control in preterm, ventilated infants. Acta Paediatr. 2021 Mar;110(3):833-837. doi: 10.1111/apa.15585. Epub 2020 Oct 6.
- Background: PubMed 31715041Sturrock S, Williams E, Dassios T, Greenough A. Closed loop automated oxygen control in neonates-A review. Acta Paediatr. 2020 May;109(5):914-922. doi: 10.1111/apa.15089. Epub 2019 Nov 27.
- Background: PubMed 30632296Dani C. Automated control of inspired oxygen (FiO2 ) in preterm infants: Literature review. Pediatr Pulmonol. 2019 Mar;54(3):358-363. doi: 10.1002/ppul.24238. Epub 2019 Jan 10.
- Background: PubMed 29895571Hunt KA, Dassios T, Ali K, Greenough A. Prediction of bronchopulmonary dysplasia development. Arch Dis Child Fetal Neonatal Ed. 2018 Nov;103(6):F598-F599. doi: 10.1136/archdischild-2018-315343. Epub 2018 Jun 12. No abstract available.
- Background: PubMed 11815545Dimitriou G, Greenough A, Endo A, Cherian S, Rafferty GF. Prediction of extubation failure in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2002 Jan;86(1):F32-5. doi: 10.1136/fn.86.1.f32.
- Background: PubMed 30894396Vliegenthart RJS, van Kaam AH, Aarnoudse-Moens CSH, van Wassenaer AG, Onland W. Duration of mechanical ventilation and neurodevelopment in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2019 Nov;104(6):F631-F635. doi: 10.1136/archdischild-2018-315993. Epub 2019 Mar 20.
- Derived from this study: PubMed 41218846Kaltsogianni O, Dassios T, Jenkinson A, Jeffreys E, Ikeda K, Sugino M, Greenough A. Closed-loop automated oxygen control in preterm ventilated infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2026 Apr 17;111(3):F243-F248. doi: 10.1136/archdischild-2025-329022.
- Individual participant dataSharing planned: No
Related trials for Infant, Premature, Diseases
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Recruiting
Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)
Preterm, Preterm Infant Development
RecruitingPhase 4
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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.
Theodore Dassios, Consultant Neonatologist contact
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?
A study of Infant, Premature, Diseases and Airway Morbidity, 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 23 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ourania Kaltsogianni, MSc ((+44)02032999000 ext. 38495, ourania.kaltsogianni@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The duration of mechanical ventilation (time frame: Through study completion, an average of 2 years). 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 NCT05030337, which also lists 13 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 23 Oct 2024.