Automated Oxygen Control in Preterms on Non-invasive Ventilation

NCT07622563 | Not Yet Recruiting

• 1 other identifier: 366356
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This randomised controlled trial aims to investigate the effectiveness of closed-loop automated oxygen control (CLAC) in preterm infants receiving non-invasive respiratory support and determine if it reduces the duration of supplementary oxygen treatment and improves achievement of oxygen saturation targets, reduces the incidences of hypoxia and hyperoxia, the number of manual adjustments to the inspired oxygen concentration (FiO2), and adverse outcomes including bronchopulmonary dysplasia (BPD). The study will take place at King's College Hospital neonatal intensive care unit (NICU). Parents of preterm infants born at less than 34 weeks of gestation and receiving non-invasive respiratory support will be approached, informed and if appropriate consented to join the trial. Participants will be randomised to receiving either automated or manual oxygen control. The study will measure outcomes including the duration of supplementary oxygen treatment, the percentage of time spent within oxygen saturation targets, the incidences of hypoxia and hyperoxia, the number of manual FiO2 adjustments required, the overall duration of non-invasive respiratory support and length of neonatal unit stay, and the incidence of BPD at 36 weeks postmenstrual age (PMA). Results will be compared between the two groups.

Conditions

Infant; Premature; Airway Morbidity

Keywords

automated oxygen control; non-invasive respiratory support; randomised controled trial; neonates

Outcome Measures

Primary Outcomes (1)

• The length of non-invasive ventilation

  Number of days participant receives non-invasive ventilation

  Through study completion, up to 36 weeks post menstrual age

Secondary Outcomes (7)

• The change in the time spent within oxygen saturation targets

  Through study completion, up to 36 weeks post menstrual age

• The change in the time spent in hypoxia (SpO2<80%)

  Through study completion, up to 36 weeks post menstrual age

• The change in the time spent in hyperoxia

  Through study completion, up to 36 weeks post menstrual age

• The change in the number of manual adjustments required

  Through study completion, up to 36 weeks post menstrual age

• The change in the duration of supplemental oxygen treatment

  Through study completion, up to 36 weeks post menstrual age

Study Arms (2)

Automated oxygen control

EXPERIMENTAL

Automated oxygen titration

Device: Closed loop automated oxygen control

Manual oxygen control

NO INTERVENTION

Manual oxygen titration

Interventions

Closed loop automated oxygen control DEVICE

The OxyGenie closed-loop oxygen saturation monitoring software (Inspiration Healthcare) 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.

Automated oxygen control

Eligibility Criteria

• Age: 22 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants \<34 weeks of gestation and at any postnatal age on non-invasive respiratory support including:
• non-invasive positive pressure ventilation (NIPPV)
• nasal CPAP
• HHFNC oxygen, either as primary or post extubation respiratory support.

You may not qualify if:

• Infants with congenital cyanotic heart disease.
• Infants with other know major congenital abnormalities.

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Related Publications (8)

• Salverda HH, Cramer SJE, Witlox RSGM, Gale TJ, Dargaville PA, Pauws SC, Te Pas AB. Comparison of two devices for automated oxygen control in preterm infants: a randomised crossover trial. Arch Dis Child Fetal Neonatal Ed. 2022 Jan;107(1):20-25. doi: 10.1136/archdischild-2020-321387. Epub 2021 Jun 10.

  PMID: 34112721 BACKGROUND

• Stafford IG, Lai NM, Tan K. Automated oxygen delivery for preterm infants with respiratory dysfunction. Cochrane Database Syst Rev. 2023 Nov 30;11(11):CD013294. doi: 10.1002/14651858.CD013294.pub2.

  PMID: 38032241 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. 2026 Apr 17;111(3):F243-F248. doi: 10.1136/archdischild-2025-329022.

  PMID: 41218846 BACKGROUND

• Kaltsogianni O, Dassios T, Greenough A. Closed-Loop Automated Oxygen Control in Preterm Infants Receiving Non-Invasive Respiratory Support. Children (Basel). 2025 Nov 11;12(11):1528. doi: 10.3390/children12111528.

  PMID: 41300645 BACKGROUND

• Claure N, Gerhardt T, Everett R, Musante G, Herrera C, Bancalari E. Closed-loop controlled inspired oxygen concentration for mechanically ventilated very low birth weight infants with frequent episodes of hypoxemia. Pediatrics. 2001 May;107(5):1120-4. doi: 10.1542/peds.107.5.1120.

  PMID: 11331696 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

• Saugstad 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.

  PMID: 21150224 BACKGROUND

• Baba 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.

  PMID: 18827514 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ourania Kaltsogianni

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ourania Kaltsogianni, MD (Res)

CONTACT

+44020 3299 9000; ourania.kaltsogianni@nhs.net

Theodore Dassios, Professor

CONTACT

02032994644; theodore.dassios@kcl.ac.uk

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: May 20, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)