Prolonged use of closed-loop inspired oxygen support in preterm infants: a randomised controlled trial

Schouten, Tim M R; Abu-Hanna, Ameen; van Kaam, Anton H; van den Heuvel, Maria E N; Bachman, Thomas E; van Leuteren, Ruud W; Hutten, G Jeroen; Onland, Wes

doi:10.1136/archdischild-2023-325831

Cited by 3 publications

(1 citation statement)

References 26 publications

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“…AOC systems consist of an oxygenation monitoring device, (pulse oximeter), gas delivery system (ventilator or cannula), and an algorithm to determine timing and degree of FiO 2 adjustments ( 119 ). Multiple studies, spanning the last 40 years, in term and very low birth weight preterm neonates have demonstrated AOC systems were more effective than manual titration in achieving oxygenation targets ( 120 – 133 ). There have been some studies that investigated long term effects and found no difference in neurodevelopmental outcome at 2 years of age between the automated oxygen control group and standard of care manual control groups ( 134 ).…”

Section: Methods Of Oxygen Measurement and Titrationmentioning

confidence: 99%

Oxygen in the neonatal ICU: a complicated history and where are we now?

Mamidi,

McEvoy

2024

Front. Pediatr.

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Despite major advances in neonatal care, oxygen remains the most commonly used medication in the neonatal intensive care unit (NICU). Supplemental oxygen can be life-saving for term and preterm neonates in the resuscitation period and beyond, however use of oxygen in the neonatal period must be judicious as there can be toxic effects. Newborns experience substantial hemodynamic changes at birth, rapid energy consumption, and decreased antioxidant capacity, which requires a delicate balance of sufficient oxygen while mitigating reactive oxygen species causing oxidative stress. In this review, we will discuss the physiology of neonates in relation to hypoxia and hyperoxic injury, the history of supplemental oxygen in the delivery room and beyond, supporting clinical research guiding trends for oxygen therapy in neonatal care, current practices, and future directions.

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Section: Methods Of Oxygen Measurement and Titrationmentioning

confidence: 99%

Oxygen in the neonatal ICU: a complicated history and where are we now?

Mamidi,

McEvoy

2024

Front. Pediatr.

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Pulse oximetry signal loss during hypoxic episodes in preterm infants receiving automated oxygen control

Langanky,

Kreutzer,

Poets

et al. 2024

Eur J Pediatr

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The aim of this study was to analyze signal loss (SL) resulting from low signal quality of pulse oximetry-derived hemoglobin oxygen saturation (SpO2) measurements during prolonged hypoxemic episodes (pHE) in very preterm infants receiving automatic oxygen control (AOC). We did a post hoc analysis of a randomized crossover study of AOC, programmed to set FiO2 to “back-up FiO2” during SL. In 24 preterm infants (median (interquartile range)) gestational age 25.3 (24.6 to 25.6) weeks, recording time 12.7 h (12.2 to 13.6 h) per infant, we identified 76 pHEs (median duration 119 s (86 to 180 s)). In 50 (66%) pHEs, SL occurred for a median duration of 51 s (33 to 85 s) and at a median frequency of 2 (1 to 2) SL-periods per pHE. SpO2 before and after SL was similar (82% (76 to 88%) vs 82% (76 to 87%), p = 0.3)). Conclusion: SL is common during pHE and must hence be considered in AOC-algorithm designs. Administering a “backup FiO2” (which reflects FiO2-requirements during normoxemia) during SL may prolong pHE with SL. Trial registration: The study was registered at www.clinicaltrials.gov under the registration no. NCT03785899. What is Known:• Previous studies examined SpO2 signal loss (SL) during routine manual oxygen control being rare, but pronounced in lower SpO2 states.• Oxygen titration during SL is unlikely to be beneficial as SpO2 may recover to a normoxic range. What is New:• Periods of low signal quality of SpO2 are common during pHEs and while supported with automated oxygen control (SPOC), FiO2 is set to a back-up value reflecting FiO2 requirements during normoxemia in response to SL, although SpO2 remained below target until signal recovery.• FiO2 overshoots following pHEs were rare during AOC and occurred with a delayed onset; therefore, increased FiO2 during SL does not necessarily lead to overshoots.

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Statistical analysis plan for the FiO2-C trial: effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcomes of extremely preterm infants—a randomized-controlled parallel group multicentre trial for safety and efficacy

König,

Stauch,

Engel

et al. 2024

Trials

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Background Extremely low gestational age neonates (ELGANs, i.e. those born before 28 weeks postmenstrual age (PMA)) often require supplemental oxygen and frequently experience intermittent hypo- and hyperoxemic episodes. Exposure to episodes with inadequate oxygen concentrations has been shown to be associated with an increased risk of retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), neurodevelopmental impairment (NDI) and death. Closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) reduces number and duration of hypo- and hyperoxemic episodes in ELGANs. Its impacts on clinically important short- and long-term outcomes such as ROP, BPD, NEC, NDI and mortality have not yet been studied. Methods An outcome-assessor-blinded, multicentre, randomized-controlled, parallel-group trial for superiority was designed to study the effects of FiO2-C (provided by standard infant ventilators) in addition to routine manual control (RMC) during respiratory support, compared to RMC only, on short- and long-term clinical outcomes in ELGANs. Two co-primary composite outcomes were defined: (i) death, severe ROP, BPD or NEC, assessed at 36 weeks PMA or, in case of ROP, until complete vascularization of the retina; (ii) death or NDI (defined as language/cognitive delay, motor impairment, severe visual impairment or hearing impairment), assessed at 2 years corrected age. Results Primary outcomes will be compared between the two intervention groups using a Cochran-Mantel-Haenszel test. The factors considered for randomization (centre, sex and gestational age at birth (< 26 weeks and ≥ 26 weeks)) will be used to define strata. Results will be presented as adjusted odds ratios with two-sided 95% and 97.5% confidence intervals and two-sided p values. Conclusions The statistical analyses for the FiO2-C trial were defined in the study protocol and specified in detail in this statistical analysis plan published prior to any statistical analysis. This is in accordance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. Trial registration ClinicalTrials.gov NCT03168516. Registered on May 30, 2017.

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Prolonged use of closed-loop inspired oxygen support in preterm infants: a randomised controlled trial

Cited by 3 publications

References 26 publications

Oxygen in the neonatal ICU: a complicated history and where are we now?

Oxygen in the neonatal ICU: a complicated history and where are we now?

Pulse oximetry signal loss during hypoxic episodes in preterm infants receiving automated oxygen control

Statistical analysis plan for the FiO2-C trial: effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcomes of extremely preterm infants—a randomized-controlled parallel group multicentre trial for safety and efficacy

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