Optimising Neonatal Ventilation with Closed-loop Oxygen Control

NCT05657795 | Completed DMC

• 1 other identifier: KCH22-163
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Ventilated newborns frequently need supplemental oxygen but its use must be monitored carefully as both giving too much or too little oxygen can have harmful effects. Giving too little oxygen results to low oxygen levels (hypoxia) and increases the risk of complications and mortality. Excessive oxygen delivery (hyperoxia) increases the risk of diseases involving several organs such as the retinas and the lungs. Although infants born very preterm require support with their breathing more often, more mature neonates may also need to be ventilated at birth and to receive supplemental oxygen. Therefore, they may suffer from problems related to hypoxia and hyperoxia. For the above reasons, oxygen levels are continuously monitored and the amount of oxygen provided is manually adjusted by the nurses and doctors. Closed-loop automated oxygen control systems (CLAC) are a more recent approach that involves the use of a computer software added to the ventilator. This software allows for automatic adjustment of the amount of oxygen provided to the baby in order to maintain oxygen levels within a desired target range depending on the baby's age and clinical condition. Previous studies in preterm and very small infants showed that automated oxygen control systems provided the right amount of oxygen for most of the time and prevented hypoxia and hyperoxia with fewer manual adjustments required by clinical staff. Preliminary results from a study that included infants born at 34 weeks gestation and beyond showed that CLAC systems allowed to reduce the amount of supplementary oxygen more rapidly. With this study we aim to compare the time spent in hyperoxia and the overall duration of oxygen treatment between infants whose oxygen is adjusted either manually or automatically while they remain ventilated. This will help us understand if CLAC systems help reduce the complications related to oxygen treatment.

Conditions

Infant, Newborn, Diseases; Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (2)

• The duration of oxygen treatment

  The duration of oxygen treatment will be measured in median (interquartile range) number of days of oxygen treatment for participants in each group.

  Through study completion, an average of 1 year

• The percentage of time spent in hyperoxia

  Target oxygen saturation range for our study population is 92-96%. Hyperoxia is defined as the time spent with oxygen saturation levels exceeding 96%. The time spent in hyperoxia will be calculated as a percentage of the total time of monitoring.

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• The percentage of time spent receiving an inspired oxygen concentration (FiO2) above 30%

  Through study completion, an average of 1 year

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 (Oxygenie, SLE 6000)

OTHER

Ventilation with Oxygenie software (closed-loop automated oxygen control system), adjusted by clinical staff as necessary

Device: Closed-loop automated oxygen control (Oxygenie, SLE6000)

Interventions

Closed-loop automated oxygen control (Oxygenie, SLE6000) 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 (Oxygenie, SLE 6000)

Eligibility Criteria

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

You may qualify if:

• Infants born at or above 34 weeks completed gestation requiring mechanical ventilation and admitted to King's NICU within 24 hours of initiation of mechanical ventilation.

You may not qualify if:

• Preterm infants less than 34 weeks gestation
• Infants with cyanotic congenital heart disease
• Infants on high frequency oscillatory ventilation (HFOV)

Sponsors & Collaborators

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

Study Sites (1)

King's College Hospital

London, London, SE5 9RS, United Kingdom

Location

Related Publications (7)

• Ramadan 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.

  PMID: 21833494 BACKGROUND

• Williams 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.

  PMID: 30287066 BACKGROUND

• Lakshminrusimha 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.

  PMID: 27225960 BACKGROUND

• Salverda HH, Cramer SJE, Witlox RSGM, Dargaville PA, Te Pas AB. Automated oxygen control in preterm infants, how does it work and what to expect: a narrative review. Arch Dis Child Fetal Neonatal Ed. 2021 Mar;106(2):215-221. doi: 10.1136/archdischild-2020-318918. Epub 2020 Jul 30.

  PMID: 32732378 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

• Abdo M, Hanbal A, Asla MM, Ishqair A, Alfar M, Elnaiem W, Ragab KM, Nourelden AZ, Zaazouee MS. Automated versus manual oxygen control in preterm infants receiving respiratory support: a systematic review and meta-analysis. J Matern Fetal Neonatal Med. 2022 Dec;35(25):6069-6076. doi: 10.1080/14767058.2021.1904875. Epub 2021 Apr 8.

  PMID: 33832390 BACKGROUND

• Kaltsogianni O, Dassios T, Jenkinson A, Greenough A. Does closed-loop automated oxygen control reduce the duration of supplementary oxygen treatment and the amount of time spent in hyperoxia? A randomised controlled trial in ventilated infants born at or near term. Trials. 2023 Jun 15;24(1):404. doi: 10.1186/s13063-023-07415-9.

  PMID: 37316885 DERIVED

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Theodore Dassios, PhD

  King's College Hospital/ King's College London

  PRINCIPAL INVESTIGATOR

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: December 12, 2022
• First Posted: December 20, 2022
• Study Start: December 7, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)