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

Autor: Nair V; Neonatal Intensive Care Unit, James Cook University Hospital, Middlesbrough, UK vrinda.nair1@nhs.net.; Faculty of Medical Sciences, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK., Kannan Loganathan P; Neonatal Intensive Care Unit, James Cook University Hospital, Middlesbrough, UK., Lal MK; Neonatal Intensive Care Unit, James Cook University Hospital, Middlesbrough, UK., Bachman TE; School of Biomedical Engineering, Ceske vysoke uceni technicke v Praze, Praha, Czech Republic., Fantl R; Clinical Informatics, Spectrum Medical, Gloucester, UK.
Jazyk: angličtina
Zdroj: Archives of disease in childhood. Fetal and neonatal edition [Arch Dis Child Fetal Neonatal Ed] 2023 Dec 15; Vol. 109 (1), pp. 65-69. Date of Electronic Publication: 2023 Dec 15.
DOI: 10.1136/archdischild-2023-325661
Abstrakt: Objective: To evaluate the efficacy of automatic oxygen control (A-FiO 2 ) in reducing the extremes of oxygen saturations (SpO 2 <80% and SpO 2 >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-FiO 2 versus manual (M-FiO 2 ) 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 SpO 2 between 90% and 95% plus time >95% without supplemental oxygen.
Results: 60 infants were randomised equally to either A-FiO 2 or M-FiO 2 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-FiO 2 and M-FiO 2 , respectively. The percentage of time spent in SpO 2 <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-FiO 2 compared with M-FiO 2 . The difference in median percentage of time in target range between the two arms was 26% (81% (74%-93%) in A-FiO 2 vs 55% (48%-72%) in M-FiO 2 ).
Conclusion: A-FiO 2 was associated with statistically significant reduction in the percentage of time spent in extremes of saturation when compared with M-FiO 2 in preterm infants receiving HFNC.
Trial Registration Number: NCT04687618.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze: MEDLINE