Randomised control trial of oxygen assist module in preterm infants on high-flow nasal cannula support
Language English Country Great Britain, England Media electronic
Document type Randomized Controlled Trial, Journal Article
PubMed
37451840
DOI
10.1136/archdischild-2023-325661
PII: archdischild-2023-325661
Knihovny.cz E-resources
- Keywords
- Child Health, Intensive Care Units, Neonatal, Neonatology,
- MeSH
- Intensive Care Units, Neonatal MeSH
- Cannula MeSH
- Infant MeSH
- Oxygen * MeSH
- Humans MeSH
- Infant, Premature * MeSH
- Infant, Newborn MeSH
- Oxygen Inhalation Therapy MeSH
- Check Tag
- Infant MeSH
- Humans MeSH
- Infant, Newborn MeSH
- Publication type
- Journal Article MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Oxygen * MeSH
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.
Clinical Informatics Spectrum Medical Gloucester UK
Neonatal Intensive Care Unit James Cook University Hospital Middlesbrough UK
School of Biomedical Engineering Ceske vysoke uceni technicke Praha Praha Czech Republic
References provided by Crossref.org
ClinicalTrials.gov
NCT04687618
