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Original research
Prolonged use of closed-loop inspired oxygen support in preterm infants: a randomised controlled trial
  1. Tim M R Schouten1,2,
  2. Ameen Abu-Hanna2,3,
  3. Anton H van Kaam1,4,
  4. Maria E N van den Heuvel5,
  5. Thomas E Bachman6,
  6. Ruud W van Leuteren1,4,
  7. G Jeroen Hutten1,4,
  8. Wes Onland1,4
  1. 1 Department of Neonatology, Emma Children's Hospital, Amsterdam UMC, Amsterdam, the Netherlands
  2. 2 Department of Medical Informatics, University of Amsterdam, Amsterdam, the Netherlands
  3. 3 Amsterdam Public Health Research Institute, Amsterdam, the Netherlands
  4. 4 Amsterdam Reproduction & Development, Amsterdam, the Netherlands
  5. 5 Department of Pediatrics and Neonatology, OLVG, Amsterdam, the Netherlands
  6. 6 Czech Technical University in Prague, Praha, Czech Republic
  1. Correspondence to Dr Wes Onland, Department of Neonatology, Emma Childrens' Hospital Amsterdam UMC, Amsterdam, Noord-Holland, the Netherlands; w.onland{at}amsterdamumc.nl

Abstract

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.

  • Intensive Care Units, Neonatal
  • Neonatology
  • Respiratory Medicine

Data availability statement

Data are available upon reasonable request. Data are available upon reasonable request. Deidentified individual participant data (including data dictionaries) will be made available in addition to study protocol, the statistical analysis plan and the analytic code. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to WO, email: w.onland@amsterdamumc.nl.

http://dx.doi.org/10.1136/archdischild-2023-325831

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    Data availability statement

    Data are available upon reasonable request. Data are available upon reasonable request. Deidentified individual participant data (including data dictionaries) will be made available in addition to study protocol, the statistical analysis plan and the analytic code. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to WO, email: w.onland@amsterdamumc.nl.

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    Footnotes

    • Contributors MRS, AA-H, AHvK, MENvdH, TEB, RWvL, GJH and WO made substantial contributions to the concept and design of the study and interpretation of data. TMRS and AA-H performed the statistical analyses, prepared the data tables, drafted the initial manuscript and revised the manuscript. MENvdH, AHvK and WO are local investigators who made substantial contributions to the concept and design of the study, had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. All authors reviewed the manuscript critically for important intellectual content. WO is the guarantor.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.