Randomised cross-over study of automated oxygen control for preterm infants receiving nasal high flow

2018 ◽  
pp. fetalneonatal-2018-315342 ◽  
Author(s):  
Peter R Reynolds ◽  
Thomas L Miller ◽  
Leonithas I Volakis ◽  
Nicky Holland ◽  
George C Dungan ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Primary Outcome Measure ◽  
High Flow ◽  
Target Range ◽  
Manual Control ◽  
Oxygen Control ◽  
Automated Control ◽  
Registration Number ◽  
Preterm Babies

ObjectiveTo evaluate a prototype automated controller (IntellO2) of the inspired fraction of oxygen (FiO2) in maintaining a target range of oxygen saturation (SpO2) in preterm babies receiving nasal high flow (HF) via the Vapotherm Precision Flow.DesignProspective two-centre order-randomised cross-over study.SettingNeonatal intensive care units.PatientsPreterm infants receiving HF with FiO2 ≥25%.InterventionAutomated versus manual control of FiO2 to maintain a target SpO2 range of 90%–95% (or 90%–100% if FiO2=21%).Main outcome measuresThe primary outcome measure was per cent of time spent within target SpO2 range. Secondary outcomes included the overall proportion and durations of SpO2 within specified hyperoxic and hypoxic ranges and the number of in-range episodes per hour.ResultsData were analysed from 30 preterm infants with median (IQR) gestation at birth of 26 (24–27) weeks, study age of 29 (18–53) days and study weight 1080 (959–1443) g. The target SpO2 range was achieved 80% of the time on automated (IntellO2) control (IQR 70%–87%) compared with 49% under manual control (IQR 40%–57%; p<0.0001). There were fewer episodes of SpO2 below 80% lasting at least 60 s under automated control (0 (IQR 0–1.25)) compared with manual control (5 (IQR 2.75–14)). There were no differences in the number of episodes per hour of SpO2 above 98% (4.5 (IQR 1.8–8.5) vs 5.5 (IQR 1.9–14); p=0.572) between the study arms.ConclusionsThe IntellO2 automated oxygen controller maintained patients in the target SpO2 range significantly better than manual adjustments in preterm babies receiving HF.Trial registration numberNCT02074774.

Automated control of oxygen titration in preterm infants on non-invasive respiratory support

2021 ◽  
pp. fetalneonatal-2020-321538
Author(s):  
Peter A Dargaville ◽  
Andrew P Marshall ◽  
Oliver J Ladlow ◽  
Charlotte Bannink ◽  
Rohan Jayakar ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Supplemental Oxygen ◽  
Respiratory Support ◽  
Target Range ◽  
Manual Control ◽  
Oxygen Control ◽  
Automated Control ◽  
Non Invasive ◽  
Automated Oxygen Control

ObjectiveTo evaluate the performance of a rapidly responsive adaptive algorithm (VDL1.1) for automated oxygen control in preterm infants with respiratory insufficiency.DesignInterventional cross-over study of a 24-hour period of automated oxygen control compared with aggregated data from two flanking periods of manual control (12 hours each).SettingNeonatal intensive care unit.ParticipantsPreterm infants receiving non-invasive respiratory support and supplemental oxygen; median birth gestation 27 weeks (IQR 26–28) and postnatal age 17 (12–23) days.InterventionAutomated oxygen titration with the VDL1.1 algorithm, with the incoming SpO2 signal derived from a standard oximetry probe, and the computed inspired oxygen concentration (FiO2) adjustments actuated by a motorised blender. The desired SpO2 range was 90%–94%, with bedside clinicians able to make corrective manual FiO2 adjustments at all times.Main outcome measuresTarget range (TR) time (SpO2 90%–94% or 90%–100% if in air), periods of SpO2 deviation, number of manual FiO2 adjustments and oxygen requirement were compared between automated and manual control periods.ResultsIn 60 cross-over studies in 35 infants, automated oxygen titration resulted in greater TR time (manual 58 (51–64)% vs automated 81 (72–85)%, p<0.001), less time at both extremes of oxygenation and considerably fewer prolonged hypoxaemic and hyperoxaemic episodes. The algorithm functioned effectively in every infant. Manual FiO2 adjustments were infrequent during automated control (0.11 adjustments/hour), and oxygen requirements were similar (manual 28 (25–32)% and automated 26 (24–32)%, p=0.13).ConclusionThe VDL1.1 algorithm was safe and effective in SpO2 targeting in preterm infants on non-invasive respiratory support.Trial registration numberACTRN12616000300471.

Predictive Intelligent Control of Oxygenation (PRICO) in preterm infants on high flow nasal cannula support: a randomised cross-over study

2021 ◽  
pp. fetalneonatal-2020-320728
Author(s):  
Koen P Dijkman ◽  
Thilo Mohns ◽  
Jeanne P Dieleman ◽  
Carola van Pul ◽  
Tom G Goos ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Intelligent Control ◽  
Neonatal Intensive Care ◽  
High Flow ◽  
Nasal Cannula ◽  
Severe Hypoxia ◽  
Target Range ◽  
High Flow Nasal Cannula ◽  
Automated Control ◽  
Ventilation Modes

ObjectiveTo investigate the efficacy of automated control of inspired oxygen (FiO2) by Predictive Intelligent Control of Oxygenation (PRICO) on the Fabian ventilator in maintaining oxygen saturation (SpO2) in preterm infants on high flow nasal cannula (HFNC) support.DesignSingle-centre randomised two-period crossover study.SettingTertiary neonatal intensive care unit.Patients27 preterm infants (gestational age (GA) <30 weeks) on HFNC support with FiO2 >0.25.InterventionA 24-hour period on automated FiO2-control with PRICO compared with a 24-hour period on routine manual control (RMC) to maintain a SpO2 level within target range of 88%–95% measured at 30 s intervals.Main outcome measuresPrimary outcome: time spent within target range (88%–95%). Secondary outcomes: time spent above and below target range, in severe hypoxia (SpO2 <80%) and hyperoxia (SpO2 >98%), mean SpO2 and FiO2 and manual FiO2 adjustments.Results15 patients received PRICO-RMC and 12 RMC-PRICO. The mean time within the target range increased with PRICO: 10.8% (95% CI 7.6 to 13.9). There was a decrease in time below target range: 7.6% (95% CI 4.2 to 11.0), above target range: 3.1% (95% CI 2.9 to 6.2) and in severe hypoxia: 0.9% (95% CI 1.5 to 0.2). We found no difference in time spent in severe hyperoxia. Mean FiO2 was higher during PRICO: 0.019 (95% CI 0.006 to 0.030). With PRICO there was a reduction of manual adjustments: 9/24 hours (95% CI 6 to 12).ConclusionIn preterm infants on HFNC support, automated FiO2-control by PRICO is superior to RMC in maintaining SpO2 within target range. Further validation studies with a higher sample frequency and different ventilation modes are needed.

Randomised crossover trial comparing algorithms and averaging times for automatic oxygen control in preterm infants

2021 ◽  
pp. fetalneonatal-2021-322096
Author(s):  
Christoph E Schwarz ◽  
Karen B Kreutzer ◽  
Lukas Langanky ◽  
Nicole S Wolf ◽  
Wolfgang Braun ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Random Order ◽  
Target Range ◽  
Oxygen Control ◽  
Non Invasive ◽  
Fraction Of Inspired Oxygen ◽  
Averaging Time ◽  
Randomised Controlled ◽  
Gestational Age At Birth

ObjectiveAutomatic control (SPOC) of the fraction of inspired oxygen (FiO2), based on continuous analysis of pulse oximeter saturation (SpO2), improves the proportion of time preterm infants spend within a specified SpO2-target range (Target%). We evaluated if a revised SPOC algorithm (SPOCnew, including an upper limit for FiO2) compared to both routine manual control (RMC) and the previously tested algorithm (SPOCold, unrestricted maximum FiO2) increases Target%, and evaluated the effect of the pulse oximeter’s averaging time on controlling the SpO2 signal during SPOC periods.DesignUnblinded, randomised controlled crossover study comparing 2 SPOC algorithms and 2 SpO2 averaging times in random order: 12 hours SPOCnew and 12 hours SPOCold (averaging time 2 s or 8 s for 6 hours each) were compared with 6-hour RMC. A generated list of random numbers was used for allocation sequence.SettingUniversity-affiliated tertiary neonatal intensive care unit, GermanyPatientsTwenty-four infants on non-invasive respiratory support with FiO2 >0.21 were analysed (median gestational age at birth, birth weight and age at randomisation were 25.3 weeks, 585 g and 30 days).Main outcome measureTarget%.ResultsMean (SD) [95% CI] Target% was 56% (9) [52, 59] for RMC versus 69% (9) [65, 72] for SPOCold_2s, 70% (7) [67, 73] for SPOCnew_2s, 71% (8) [68, 74] for SPOCold_8s and 72% (8) [69, 75] for SPOCnew_8s.ConclusionsIrrespective of SpO2-averaging time, Target% was higher with both SPOC algorithms compared to RMC. Despite limiting the maximum FiO2, SPOCnew remained significantly better at maintaining SpO2 within target range compared to RMC.Trial registrationNCT03785899

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

2021 ◽  
pp. fetalneonatal-2021-321712
Author(s):  
Vrinda Nair ◽  
Mithilesh Kumar Lal ◽  
Jenna Gillone ◽  
Prakash Kannan Loganathan ◽  
Thomas Edward Bachman
Keyword(s):  
Crossover Study ◽  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Primary Outcome ◽  
Target Range ◽  
Oxygen Control ◽  
Controlled Ventilation ◽  
Volume Controlled Ventilation ◽  
Significant Difference ◽  
Volume Controlled

ObjectiveThe 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).DesignA single-centre randomised crossover study.SettingsA level III neonatal intensive care unit.PatientsPreterm infants receiving mechanical ventilation and oxygen requirement >21%.InterventionsVolume guarantee (VG) vs volume controlled ventilation (VCV) modes with automatic oxygen control (A-FiO2).OutcomesThe primary outcome of this study was the proportion of time spent with oxygen saturations in the target range (90%–95%) .ResultsNineteen 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.ConclusionThere 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 numberNCT03865069.

scholarly journals Designing a Remote Closed-Loop Automatic Oxygen Control in Preterm Infants

2020 ◽  
Vol 30 (4) ◽  
Author(s):  
Mohammad Reza Moradi ◽  
Sharareh R. Niakan Kalhori ◽  
Marian Ghazi Saeedi ◽  
Mohammad Reza Zarkesh ◽  
Abbas Habibelahi ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Pulse Oximeter ◽  
Closed Loop ◽  
Arterial Oxygen Saturation ◽  
Arterial Oxygen ◽  
Target Range ◽  
Preterm Neonates ◽  
Oxygen Control ◽  
Fraction Of Inspired Oxygen ◽  
To Receive

Background: Different automated systems have been developed to improve the maintenance of target range of arterial oxygen saturation (SPO2) in premature infants with respiratory distress. Objectives: This study aimed to develop a remote closed-loop automatic oxygen control (RCLAC) as an efficient monitoring device. Then the means of the fraction of inspired oxygen (FIO2) and SPO2 by routine manual control (RMC) and RCLAC were compared. Methods: A developmental-descriptive study was carried out in an Iranian hospital (Tehran, Iran; 2015 - 2017). Twenty-two preterm infants with gestational age 24 - 28 weeks entered the study. A database was prepared based on pulse oximeter parameters. A Wi-Fi module was implemented to receive data from a pulse oximeter and send inputs to the user’s mobile. Vibrate alarm was implemented for high or low FIO2. After receiving notifications associated with an increase or decrease of FIO2 levels and user’s confirmation; the alterations were applied on the ventilator. Results: The mean FIO2 in the RMC system was significantly higher than the RCLAC system (98.1 ± 2.67 vs 79.5 ± 16.03; P = 0.0001). According to the results, when the SPO2 reached close to target SPO2 range and consequently FIO2 changed (decreased or increased based on target SPO2), heart rate showed a regular beating with a decrease in the numbers. Conclusions: Remote closed-loop automatic oxygen control system as a simple device could prevent preterm neonates from sustained hypo-hyperoxemic and arrhythmia episodes. Moreover, by using RCLAC, there was no need for continuous monitoring that may reduce the workload of NICU medical staff. Collecting reliable data and recording information in digital forms were also other benefits. Further studies with larger sample size are strongly suggested.

Comparative Study of the Effects of Continuous Positive Airway Pressure and Nasal High-Flow Therapy on Diaphragmatic Dimensions in Preterm Infants

2017 ◽  
Vol 35 (05) ◽  
pp. 448-454 ◽  
Author(s):  
Mohamed El-Mogy ◽  
Hanan El-Halaby ◽  
Gehan Attia ◽  
Hesham Abdel-Hady
Keyword(s):  
Continuous Positive Airway Pressure ◽  
Preterm Infants ◽  
Airway Pressure ◽  
Positive Airway Pressure ◽  
High Flow ◽  
Clinical Trial Registration ◽  
Respiratory Dysfunction ◽  
Registration Number ◽  
Group 2 ◽  
Nasal High Flow Therapy

Objective Nasal continuous positive airway pressure (nCPAP) and nasal high-flow therapy (nHFT) are the most common forms of noninvasive respiratory support in preterm infants. We conducted this study to compare effects of nCPAP and nHFT on diaphragmatic dimensions as assessed by bedside ultrasonography in preterm infants. Study Design A prospective, randomized crossover study comprised 24 preterm infants. Group 1 (n = 12): started on nCPAP for 60 minutes and then switched to nHFT for 60 minutes. Group 2 (n = 12): started on nHFT for 60 minutes then switched to nCPAP for 60 minutes. Ultrasonographic assessment of diaphragmatic dimensions was performed at the end of each epoch. Results There were no statistically significant differences in diaphragmatic dimensions at the end of each epoch of nCPAP or nHFT. The diaphragm thickening fraction (DTF) was not significantly different with either nCPAP or nHFT [23.4 (13.7–28.0) versus 23.4 (11.2–31.6), p = 0.57]. No significant differences were found regarding heart rate, respiratory rate, Silverman–Anderson scores, and SpO2 on nCPAP and nHFT. All infants enrolled tolerated the crossover maneuver. Conclusion Stable preterm infants (30.3 ± 2.2 weeks' gestation) with mild respiratory dysfunction show comparable effects on diaphragm thickness and excursion during relatively brief periods of support on nCPAP or nHFT. Clinical Trial Registration Registry name: Clinical Trials.gov. Registration number: NCT02421328. Web link to study on registry: https://clinicaltrials.gov/ct2/show/NCT02421328.

Continuous neurally adjusted ventilation: a feasibility study in preterm infants

2020 ◽  
Vol 105 (6) ◽  
pp. 640-645
Author(s):  
Marie-Eve Rochon ◽  
Gregory Lodygensky ◽  
Laurence Tabone ◽  
Sandrine Essouri ◽  
Sylvain Morneau ◽  
...  
Keyword(s):  
Electrical Activity ◽  
Preterm Infants ◽  
Feasibility Study ◽  
Neonatal Intensive Care ◽  
Positive Pressure ◽  
Non Invasive ◽  
Diaphragm Electrical Activity ◽  
Registration Number ◽  
Level 3 ◽  
The Impact

ObjectivesTo assess the feasibility and tolerance of NeuroPAP, a new non-invasive ventilation mode which continuously adjusts (during both inspiration and expiration) the pressure support proportionally to the diaphragm electrical activity (Edi), in preterm infants and to evaluate the impact on ventilation pressure and Edi.DesignProspective cross-over single-centre feasibility study.SettingOne level 3 neonatal intensive care unit in Canada.PatientsStable preterm infants ventilated with non-invasive positive pressure ventilation (NIPPV).InterventionsSubjects were successively ventilated in NIPPV with prestudy settings (30 min), in NeuroPAP with minimal pressure similar to NIPPV PEEP (positive end-expiratory pressure) (60 min), in NeuroPAP with minimal pressure reduced by 2 cmH20 (60 min), in continuous positive airway pressure (15 min) and again in NIPPV (30 min). Main outcome measures included tolerance, ventilation pressure, Edi and patient-ventilator synchrony.ResultsTwenty infants born at 28.0±1.0 weeks were included. NeuroPAP was well tolerated and could be delivered during 100% of planned period. During NeuroPAP, the PEEP was continuously adjusted proportionally to tonic diaphragm Edi, although the average PEEP value was similar to the set minimal pressure. During NeuroPAP, 83 (78–86)% breaths were well synchronised vs 9 (6–12)% breaths during NIPPV (p<0.001).ConclusionsNeuroPAP is feasible and well tolerated in stable preterm infants, and it allows transient adaptation in PEEP in response to tonic diaphragm electrical activity changes. Further studies are warranted to determine the impact of these findings on clinical outcomes.Trial registration numberNCT02480205.

scholarly journals Comparison of two devices for automated oxygen control in preterm infants: a randomised crossover trial

2021 ◽  
pp. fetalneonatal-2020-321387
Author(s):  
Hylke H Salverda ◽  
Sophie J E Cramer ◽  
Ruben S G M Witlox ◽  
Timothy J Gale ◽  
Peter A Dargaville ◽  
...  
Keyword(s):  
Oxygen Saturation ◽  
Preterm Infants ◽  
Random Sequence ◽  
Supplemental Oxygen ◽  
Respiratory Support ◽  
Target Range ◽  
Oxygen Control ◽  
Significant Difference ◽  
The Cost ◽  
Automated Oxygen Control

ObjectiveTo compare the effect of two different automated oxygen control devices on target range (TR) time and occurrence of hypoxaemic and hyperoxaemic episodes.DesignRandomised cross-over study.SettingTertiary level neonatal unit in the Netherlands.PatientsPreterm infants (n=15) born between 24+0 and 29+6 days of gestation, receiving invasive or non-invasive respiratory support with oxygen saturation (SpO2) TR of 91%–95%. Median gestational age 26 weeks and 4 days (IQR 25 weeks 3 days–27 weeks 6 days) and postnatal age 19 (IQR 17–24) days.InterventionsInspired oxygen concentration was titrated by the OxyGenie controller (SLE6000 ventilator) and the CLiO2 controller (AVEA ventilator) for 24 hours each, in a random sequence, with the respiratory support mode kept constant.Main outcome measuresTime spent within set SpO2 TR (91%–95% with supplemental oxygen and 91%–100% without supplemental oxygen).ResultsTime spent within the SpO2 TR was higher during OxyGenie control (80.2 (72.6–82.4)% vs 68.5 (56.7–79.3)%, p<0.005). Less time was spent above TR while in supplemental oxygen (6.3 (5.1–9.9)% vs 15.9 (11.5–30.7)%, p<0.005) but more time spent below TR during OxyGenie control (14.7 (11.8%–17.2%) vs 9.3 (8.2–12.6)%, p<0.05). There was no significant difference in time with SpO2 <80% (0.5 (0.1–1.0)% vs 0.2 (0.1–0.4)%, p=0.061). Long-lasting SpO2 deviations occurred less frequently during OxyGenie control.ConclusionsThe OxyGenie control algorithm was more effective in keeping the oxygen saturation within TR and preventing hyperoxaemia and equally effective in preventing hypoxaemia (SpO2 <80%), although at the cost of a small increase in mild hypoxaemia.Trial registry numberNCT03877198

scholarly journals Nutritional management of preterm newborn after hospital discharge: energy and nutrients

2017 ◽  
Author(s):  
Elisabetta Villa ◽  
Roberta Barachetti ◽  
Mario Barbarini
Keyword(s):  
Human Milk ◽  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Convincing Evidence ◽  
The Body ◽  
Post Discharge ◽  
Poor Growth ◽  
Preterm Babies

Preterm infants are at risk for poor growth while in the Neonatal Intensive Care Unit (NICU) and after discharge from the NICU. The main objective is to reach the body composition and rate of growth of a normal fetus/infant of the same post-menstrual age during the first entire year of life. In case of human milk, the limited data do not provide convincing evidence that feeding preterm infants after discharge with multi-nutrient fortified human milk, compared with unfortified, affects important outcomes including growth rates during infancy. Conversely, if formula-fed, post discharge formulas produce short term advantages in growth rate but no long term advantages are demonstrated. It is very important to establish a feeding plan and a follow up for all preterm babies who are discharged from NICU in order to recognize as soon as possible any growth deficit.

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