Automatic Oxygen Control for Reducing Extremes of Oxygen Saturation (AreOS): A Randomised Control Trial

NCT04223258 | Completed DMC

• 1 other identifier: 277057
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Oxygen treatment is common in babies born early (preterm) and requiring intensive care. Having too much or too little oxygen can increase the risk of damage to the eyes and lungs, and contribute to death or disability. Preterm infants because of their immaturity experience episodes of low oxygen levels. The low oxygen episodes are primarily due to pauses in their breathing (Apnoea of prematurity) and immaturity of their lung. These episodes persist for weeks. The lower the gestation at birth the longer the duration of these events. Studies have shown that these episodes of low oxygen saturations especially if frequent and prolonged is associated with poor developmental outcome, severe eye disease and lung disease. Traditionally, the oxygen delivery is manually adjusted when infant has low oxygen saturation. However previous studies have shown despite the best efforts the oxygen level can only be maintained less than half of the time and nearly a one-fifth of the time infant spends in low oxygen levels and nearly one third of the time in high oxygen levels. Now it is possible to maintain oxygen level in target range by using automatic control of oxygen delivery. With the proposed study, we would like to study the efficacy of automatic control of oxygen delivery in reducing the time spent in low oxygen levels.

Conditions

Prematurity

Keywords

Preterm Infants; Automatic oxygen control; Respiratory support

Outcome Measures

Primary Outcomes (1)

• proportion of time spent in extreme saturation ( less than or equal to 80%)

  The primary outcome of this study is proportion of time spent in extreme saturation (less than or equal to 80%) in preterm infants \<33 weeks receiving invasive or non-invasive form of respiratory support.

  Through study completion, an average of 8 weeks

Secondary Outcomes (9)

• Proportion of time spent in target saturation

  Through study completion, an average of 8 weeks

• Proportion of time spent in saturation more than or equal to 98%

  Through study completion, an average of 8 weeks

• Number of episodes of prolonged hypoxemia (SpO2 less than 80% for more than 60 sec)

  Through study completion, an average of 8 weeks

• Brochopulmonary Dysplasia at 36 weeks PMA

  Upto 36 weeks post menstrual age

• Oxygen need at day 28

  4 weeks

Study Arms (2)

Automatic Oxygen Control

EXPERIMENTAL

Infants randomized to this arm will be monitored using automatic oxygen control system on the ventilator. When infants oxygen saturation are out of the target range the ventilator will adjust the oxygen delivery depending on the saturation of the infant to bring the saturation int he target range.

Device: Automatic Oxygen control

Manual oxygen control

ACTIVE COMPARATOR

Infants randomized to this arm will be receive oxygen delivery adjustments manually by the nursing and medical team taking care of the infants. When the infants oxygen saturation are out of the target range, the staff will manually adjust the oxygen delivery.

Other: Manual Oxygen Control

Interventions

Automatic Oxygen control DEVICE

The CLiO device is integral to the Avea infant ventilator and allows automated OXYGEN adjustment aiming to maintain SpO2 within assigned target range using neonatal pulse oximeter. When first started it adopts the FiO2 previously set by the clinician as the initial 'Baseline FiO2' level. Thereafter, the changes to the FiO2 and their frequency depend on whether SpO2 is below, above or within the target range, the trend in SpO2 and all changes are proportionate to the 'Baseline FiO2' level.

Automatic Oxygen Control

Manual Oxygen Control OTHER

In the manual arm the oxygen is adjusted manually by the clinical team.

Manual oxygen control

Eligibility Criteria

• Age: 23 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants less than 33 weeks (23+0 to 32+6 weeks)
• Receiving invasive or non-invasive mode of respiratory support

You may not qualify if:

• Infants more than or equal to 33 weeks
• Preterm infants with congenital anomalies
• Infants on a non-conventional mode of invasive or non-invasive ventilation

Sponsors & Collaborators

• South Tees Hospitals NHS Foundation Trust: lead
• Vyaire Medical: collaborator

Study Sites (1)

South Tees NHS Trust

Middlesbrough, TS4 3BW, United Kingdom

Location

Related Publications (8)

• Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, Hale EC, Newman NS, Schibler K, Carlo WA, Kennedy KA, Poindexter BB, Finer NN, Ehrenkranz RA, Duara S, Sanchez PJ, O'Shea TM, Goldberg RN, Van Meurs KP, Faix RG, Phelps DL, Frantz ID 3rd, Watterberg KL, Saha S, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network. Pediatrics. 2010 Sep;126(3):443-56. doi: 10.1542/peds.2009-2959. Epub 2010 Aug 23.

  PMID: 20732945 BACKGROUND

• Martin RJ, Wang K, Koroglu O, Di Fiore J, Kc P. Intermittent hypoxic episodes in preterm infants: do they matter? Neonatology. 2011;100(3):303-10. doi: 10.1159/000329922. Epub 2011 Oct 3.

  PMID: 21986336 BACKGROUND

• SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network; Carlo WA, Finer NN, Walsh MC, Rich W, Gantz MG, Laptook AR, Yoder BA, Faix RG, Das A, Poole WK, Schibler K, Newman NS, Ambalavanan N, Frantz ID 3rd, Piazza AJ, Sanchez PJ, Morris BH, Laroia N, Phelps DL, Poindexter BB, Cotten CM, Van Meurs KP, Duara S, Narendran V, Sood BG, O'Shea TM, Bell EF, Ehrenkranz RA, Watterberg KL, Higgins RD. Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med. 2010 May 27;362(21):1959-69. doi: 10.1056/NEJMoa0911781. Epub 2010 May 16.

  PMID: 20472937 BACKGROUND

• Stenson B, Brocklehurst P, Tarnow-Mordi W; U.K. BOOST II trial; Australian BOOST II trial; New Zealand BOOST II trial. Increased 36-week survival with high oxygen saturation target in extremely preterm infants. N Engl J Med. 2011 Apr 28;364(17):1680-2. doi: 10.1056/NEJMc1101319. No abstract available.

  PMID: 21524227 BACKGROUND

• Poets CF, Roberts RS, Schmidt B, Whyte RK, Asztalos EV, Bader D, Bairam A, Moddemann D, Peliowski A, Rabi Y, Solimano A, Nelson H; Canadian Oxygen Trial Investigators. Association Between Intermittent Hypoxemia or Bradycardia and Late Death or Disability in Extremely Preterm Infants. JAMA. 2015 Aug 11;314(6):595-603. doi: 10.1001/jama.2015.8841.

  PMID: 26262797 BACKGROUND

• Laptook AR, Salhab W, Allen J, Saha S, Walsh M. Pulse oximetry in very low birth weight infants: can oxygen saturation be maintained in the desired range? J Perinatol. 2006 Jun;26(6):337-41. doi: 10.1038/sj.jp.7211500.

  PMID: 16598294 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

• Nair V, Kannan Loganathan P, Lal MK, Pringleton H, Bachman TE, Brodlie M, Dixon P. Automatic oxygen control for reducing extremes of oxygen saturation: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2023 Mar;108(2):136-141. doi: 10.1136/archdischild-2022-324160. Epub 2022 Aug 23.

  PMID: 35999043 DERIVED

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

• Vrinda Nair, MD,FRCPCH

  South Tees NHS trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 10, 2020
• Study Start: October 1, 2020
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)