Randomised control trial of oxygen assist module in preterm infants on high-flow nasal cannula support

Arch Dis Child Fetal Neonatal Ed. 2023 Dec 15;109(1):65-69. doi: 10.1136/archdischild-2023-325661.

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.

Keywords: Child Health; Intensive Care Units, Neonatal; Neonatology.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Cannula
  • Humans
  • Infant
  • Infant, Newborn
  • Infant, Premature*
  • Intensive Care Units, Neonatal
  • Oxygen Inhalation Therapy
  • Oxygen*

Substances

  • Oxygen

Associated data

  • ClinicalTrials.gov/NCT04687618