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Updated: Jul 13, 2025
A Swine Model of Neonatal Asphyxia
Published on: October 11, 2011
Prolonged use of closed-loop inspired oxygen support in preterm infants: a randomised controlled trial
Tim M R Schouten1,2, Ameen Abu-Hanna2,3, Anton H van Kaam1,4
1Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, Amsterdam, the Netherlands.
Insights
Automated oxygen control (A-FiO2) kept preterm infants on non-invasive support within the target oxygen saturation range more effectively than manual control. While A-FiO2 reduced hyperoxia, initial use may increase hypoxemia risk in the early days.
Area of Science:
- Neonatal Intensive Care
- Respiratory Support
- Pediatric Critical Care
Background:
- Maintaining optimal oxygen saturation (SpO2) in preterm infants on respiratory support is challenging.
- Manual titration of fraction of inspired oxygen (FiO2) can lead to significant periods outside the target range.
- Automated oxygen control systems aim to improve SpO2 stability.
Purpose of the Study:
- To compare the effectiveness of automated oxygen control (A-FiO2) versus manual titration (M-FiO2) in maintaining SpO2 within a target range in preterm infants.
- To evaluate the impact of A-FiO2 on hyperoxemia and hypoxemia over a 28-day period.
Main Methods:
- A single-center randomized controlled trial was conducted in a level III neonatal intensive care unit.
- Preterm infants (<28 weeks gestation) receiving non-invasive respiratory support were randomized to A-FiO2 or M-FiO2.
- Outcomes included time within the target range, hyperoxemia, hypoxemia, and trends over 28 days using linear random intercept models.
Main Results:
- The A-FiO2 group spent significantly more time within the target SpO2 range (68.7% vs. 48.0%, p<0.001).
- A-FiO2 significantly reduced time spent in hyperoxemia (13.8% vs. 37.7%, p<0.001) but did not differ in hypoxemia.
- Time-based analysis indicated potential differences in A-FiO2 efficacy over time, particularly for hypoxemia, with an inverse trend observed.
Conclusions:
- Automated oxygen control (A-FiO2) is superior to manual titration (M-FiO2) for maintaining target SpO2 in preterm infants on non-invasive respiratory support.
- The benefits of A-FiO2 may be associated with increased time below the target range in the initial days of use.
- A-FiO2 represents a promising advancement in respiratory support for vulnerable preterm infants.
Objective:
This randomised study in preterm infants on non-invasive respiratory support investigated the effectiveness of automated oxygen control (A-FiO2) in keeping the oxygen saturation (SpO2) within a target range (TR) during a 28-day period compared with manual titration (M-FiO2).
Design:
A single-centre randomised control trial.
Setting:
A level III neonatal intensive care unit.
Patients:
Preterm infants (<28 weeks' gestation) on non-invasive respiratory support.
Interventions:
A-FiO2 versus M-FiO2 control.
Methods:
Main outcomes were the proportion of time spent and median area of episodes in the TR, hyperoxaemia, hypoxaemia and the trend over 28 days using a linear random intercept model.
Results:
23 preterm infants (median gestation 25.7 weeks; birth weight 820 g) were randomised. Compared with M-FiO2, the time spent within TR was higher in the A-FiO2 group (68.7% vs 48.0%, p<0.001). Infants in the A-FiO2 group spent less time in hyperoxaemia (13.8% vs 37.7%, p<0.001), but no difference was found in hypoxaemia. The time-based analyses showed that the A-FiO2 efficacy may differ over time, especially for hypoxaemia. Compared with the M-FiO2 group, the A-FiO2 group had a larger intercept but with an inversed slope for the daily median area below the TR (intercept 70.1 vs 36.3; estimate/day -0.70 vs 0.69, p<0.001).
Conclusion:
A-FiO2 control was superior to manual control in keeping preterm infants on non-invasive respiratory support in a prespecified TR over a period of 28 days. This improvement may come at the expense of increased time below the TR in the first days after initiating A-FiO2 control.
Trial Registration Number:
NTR6731.
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