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

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.

Automatic oxygen control for reducing extremes of oxygen saturation: a randomised controlled trial.

OBJECTIVE: The objective of this study was to evaluate the efficacy of the automatic oxygen control (A-Fio2) in reducing the percentage of time spent in severe hypoxaemia (Spo2 <80%) in preterm infants for the time period on invasive ventilation and/or nasal continuous positive airway pressure (NCPAP) delivered by AVEA ventilator. DESIGN: A parallel arm randomised controlled trial. SETTING: A level-III neonatal intensive care unit. PATIENTS: Preterm infants (<33 weeks birth gestation) who received invasive ventilation or NCPAP in the first 72 hours of age. INTERVENTIONS: A-Fio2 vs manual (M-Fio2) oxygen control. OUTCOMES: The primary outcome of the study was percentage of time spent in severe hypoxaemia (Spo2 <80%). RESULTS: 44 infants were randomised to either A-Fio2 or M-Fio2 arm and continued in the study for the period of respiratory support (invasive ventilation and/or NCPAP). The total number of study days in A-Fio2 and M-Fio2 arm were 194 and 204 days, respectively. The percentage of time spent in Spo2 <80% was significantly lower with A-Fio2 compared with M-Fio2 (median of 0.1% (IQR: 0.07-0.7) vs 0.6% (0.2-2); p=0.03). The number of prolonged episodes (>60 s) of Spo2 <80% per day was also significantly lower in A-Fio2 (0.3 (0.0-2) vs 2 (0.6-6); p=0.02). CONCLUSION: A-Fio2 was associated with statistically significant reduction in the percentage of time spent in severe hypoxaemia when compared with M-Fio2 in preterm infants receiving respiratory support. TRIAL REGISTRATION NUMBER: NCT04223258.

Outcomes of Preterm Infants Who Experienced Unplanned Extubation.

BACKGROUND: Unplanned extubation (UE) is associated with adverse outcomes. The aim of the study was to compare the clinical outcomes in preterm infants who experienced at least one UE to those who did not experience any UE. METHODS: The matched cohort study compared ventilated preterm infants < 32 weeks who experienced UE to those who did not experience any UE. The main outcomes were duration of mechanical ventilation after matching, duration of hospital stay, retinopathy of prematurity (ROP) requiring intervention, and bronchopulmonary dysplasia (BPD). RESULTS: Forty-seven infants were included in each group. The groups were matched for mechanical ventilation duration before UE, birth gestation, and birthweight. The duration of mechanical ventilation after matching (adjusted odds ratio [aOR] 14.8 [11.2-18.4], P = <.001), the total length of stay in the hospital (aOR 16.4 [3.7-29.2], P = .01), and severe ROP (aOR 6.7 [1.7-27.0], P = .007) were significantly higher in infants who experienced UE. After adjusting for mechanical ventilation duration, UE was not associated with ROP or BPD. However, infants who spent longer time on mechanical ventilation had higher odds of developing ROP (aOR 1.1 [1.0-1.2], P = .004) and BPD (aOR 1.5 [1.1-2.1], P = .01). Sensitivity analysis including infants who had UE and managed on noninvasive respiratory support showed significant association between UE and the outcomes of duration of mechanical ventilation, hospital length of stay, ROP, and BPD. CONCLUSIONS: Infants who experienced UE had higher odds of spending longer time on mechanical ventilation and spent significantly more days in the hospital.

Automated Oxygen Delivery in Neonatal Intensive Care.

Oxygen is the most common drug used in the neonatal intensive care. It has a narrow therapeutic range in preterm infants. Too high (hyperoxemia) or low oxygen (hypoxemia) is associated with adverse neonatal outcomes. It is not only prudent to maintain oxygen saturations in the target range, but also to avoid extremes of oxygen saturations. In routine practice when done manually by the staff, it is challenging to maintain oxygen saturations within the target range. Automatic control of oxygen delivery is now feasible and has shown to improve the time spent with in the target range of oxygen saturations. In addition, it also helps to avoid extremes of oxygen saturation. However, there are no studies that evaluated the clinical outcomes with automatic control of oxygen delivery. In this narrative review article, we aim to present the current evidence on automatic oxygen control and the future directions.

Comparison of volume guarantee and volume-controlled ventilation both using closed loop inspired oxygen in preterm infants: a randomised crossover study (CLIO-VG study).

OBJECTIVE: The objective of this study was to compare two different modes of ventilation in maintaining oxygen saturation (SpO2) in target range (90%-95%) in ventilated preterm infants cared for with automatic control of oxygen delivery (A-FiO2). DESIGN: A single-centre randomised crossover study. SETTINGS: A level III neonatal intensive care unit. PATIENTS: Preterm infants receiving mechanical ventilation and oxygen requirement >21%. INTERVENTIONS: Volume guarantee (VG) vs volume controlled ventilation (VCV) modes with automatic oxygen control (A-FiO2). OUTCOMES: The primary outcome of this study was the proportion of time spent with oxygen saturations in the target range (90%-95%) . RESULTS: Nineteen preterm infants with a median gestation age 25 weeks (IQR: 24-28) and birth weight 685 g (IQR: 595-980) were enrolled in the study. There was no significant difference in primary outcome of median proportion of time spent in target saturation between the two arms (72% (57-81) in VG vs 75% (58-83) in VCV; p=0.98). There was no significant difference in the secondary outcomes of time spent in SpO2 <80% (0.03% vs 0.14%; p=0.51), time spent in SpO2 >98% (0.50% vs 0.08%; p=0.54), the median FiO2 (31% vs 29%; p=0.51) or manual adjustments carried out between VG and VCV, respectively. The number of episodes of prolonged hypoxaemia and hyperoxaemia were similar in the two groups. CONCLUSION: There was no significant difference in time spent in target SpO2 range between VG and VCV when A-FiO2 was used as the FiO2 controller in this crossover randomised control study. TRIAL REGISTRATION NUMBER: NCT03865069.