Optimising Ventilation in Preterms With Closed-loop Oxygen Control

NCT05030337 | Recruiting DMC

• 2 other identifiers: 297749KCH21-111
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Infant, Premature, Diseases; Airway Morbidity; Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 2 years

Secondary Outcomes (5)

• The percentage of time spent within target oxygen saturation range.

  Through study completion, an average of 2 years

• Number of manual adjustments to the inspired oxygen concentration required by clinical staff.

  Through study completion, an average of 2 years

• Number of days on oxygen.

  Through study completion, an average of 2 years

• Length of Intensive Care stay

  Through study completion, an average of 2 years

• A diagnosis of bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age

  Through study completion, an average of 2 years

Study Arms (2)

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

Device: Closed-loop automated oxygen control (Oxygenie, SLE 6000)

Interventions

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.

Closed-loop automated oxygen control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Preterm infants above 31 weeks completed gestation or term born infants
• Infants with major congenital abnormalities

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• King's College London: collaborator

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

Related Publications (13)

• 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.

  PMID: 23910576 BACKGROUND

• Di 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.

  PMID: 20304417 BACKGROUND

• Hagadorn 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.

  PMID: 17015549 BACKGROUND

• Ford 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.

  PMID: 17079621 BACKGROUND

• Sink 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.

  PMID: 21037284 BACKGROUND

• Sturrock 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.

  PMID: 32969040 BACKGROUND

• Sturrock 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.

  PMID: 31715041 BACKGROUND

• Dani 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.

  PMID: 30632296 BACKGROUND

• Hunt 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.

  PMID: 29895571 BACKGROUND

• Dimitriou 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.

  PMID: 11815545 BACKGROUND

• Vliegenthart 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.

  PMID: 30894396 BACKGROUND

• Kaltsogianni 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. 2025 Nov 10:fetalneonatal-2025-329022. doi: 10.1136/archdischild-2025-329022. Online ahead of print.

  PMID: 41218846 DERIVED

• Kaltsogianni 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.

  PMID: 35395952 DERIVED

MeSH Terms

Conditions

Infant, Premature, Diseases

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Anne Greenough, Professor

  King's College Hospital/ King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ourania Kaltsogianni, MSc

CONTACT

(+44)02032999000; ourania.kaltsogianni@nhs.net

Theodore Dassios, Consultant Neonatologist

CONTACT

theodore.dassios@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participating infants will be randomised either to manual oxygen control or closed-loop automated oxygen control, adjusted by clinical staff as necessary.

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: September 1, 2021
• Study Start: September 5, 2021
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)