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Original research
Randomised control trial of oxygen assist module in preterm infants on high-flow nasal cannula support
  1. Vrinda Nair1,2,
  2. Prakash Kannan Loganathan1,
  3. Mithilesh Kumar Lal1,
  4. Thomas Edward Bachman3,
  5. Ron Fantl4
  1. 1 Neonatal Intensive Care Unit, James Cook University Hospital, Middlesbrough, UK
  2. 2 Faculty of Medical Sciences, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK
  3. 3 School of Biomedical Engineering, Ceske vysoke uceni technicke v Praze, Praha, Czech Republic
  4. 4 Clinical Informatics, Spectrum Medical, Gloucester, UK
  1. Correspondence to Dr Vrinda Nair, Neonatal Intensive Care Unit, James Cook University Hospital, Middlesbrough, UK; vrinda.nair1{at}nhs.net

Abstract

Objective To evaluate the efficacy of automatic oxygen control (A-FiO2) in reducing the extremes of oxygen saturations (SpO2<80% and SpO2>98%) in preterm infants on high-flow nasal cannula (HFNC) respiratory support using Vapotherm Precision Flow.

Design A parallel-arm randomised controlled trial.

Setting A level-III neonatal intensive care unit.

Patients Preterm infants born <33 (23+0 to 32+6) weeks receiving HFNC as respiratory support.

Interventions A-FiO2 versus manual (M-FiO2) oxygen control during the full course of HFNC support.

Outcomes The primary outcome of this study is percentage of time spent in extreme oxygen saturations (<80% and >98%) in preterm infants when receiving HFNC as respiratory support. Secondary outcomes were time with SpO2 between 90% and 95% plus time >95% without supplemental oxygen.

Results 60 infants were randomised equally to either A-FiO2 or M-FiO2 arm. Their baseline characteristics were comparable. They spent a median of 5.3 (IQR: 2.0–8.4) and 6.5 (IQR: 2.9–13.7) days in the study, A-FiO2 and M-FiO2, respectively. The percentage of time spent in SpO2<80% (median of 0.4% (0.1%–0.8%) vs 1.6% (0.6%–2.6%), p=0.002) and >98% (median 0.2% (0.1%–0.9%) vs 1.9% (0.7%–4%), p<0.001) were significantly lower in A-FiO2 compared with M-FiO2. The difference in median percentage of time in target range between the two arms was 26% (81% (74%–93%) in A-FiO2 vs 55% (48%–72%) in M-FiO2).

Conclusion A-FiO2 was associated with statistically significant reduction in the percentage of time spent in extremes of saturation when compared with M-FiO2 in preterm infants receiving HFNC.

Trial registration number NCT04687618.

  • Child Health
  • Intensive Care Units, Neonatal
  • Neonatology

Data availability statement

All data relevant to the study are included in the article or uploaded as supplementary information.

http://dx.doi.org/10.1136/archdischild-2023-325661

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    Data availability statement

    All data relevant to the study are included in the article or uploaded as supplementary information.

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    Footnotes

    • Twitter @PrakashLogana10

    • Contributors VN, PKL and MKL conceptualised and designed the study, collected the data, carried out the initial analysis, drafted the initial manuscript, reviewed and revised the manuscript. TEB designed the study, extracted the endpoints from data logger data, carried out the statistical analysis, reviewed and revised the manuscript. RF designed the study and provided the technical support with case file analyser and data extraction. All authors approved the final manuscript as submitted and agreed to be accountable for all aspects of the work. VN is responsible for overall content as a guarantor.

    • Funding Vapotherm, Inc. provided the OAM units for the study. Vapotherm, Inc. had no role in the design and conduct of the study.

    • Disclaimer RF formally worked for the manufacturer of the A-FiO2 system.

    • Competing interests None declared.

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