OBJECTIVE: This randomised study in preterm infants on non-invasive respiratory support investigated the effectiveness of automated oxygen control (A-FiO2) in keeping the oxygen saturation (SpO2) within a target range (TR) during a 28-day period compared with manual titration (M-FiO2). DESIGN: A single-centre randomised control trial. SETTING: A level III neonatal intensive care unit. PATIENTS: Preterm infants (<28 weeks' gestation) on non-invasive respiratory support. INTERVENTIONS: A-FiO2 versus M-FiO2 control. METHODS: Main outcomes were the proportion of time spent and median area of episodes in the TR, hyperoxaemia, hypoxaemia and the trend over 28 days using a linear random intercept model. RESULTS: 23 preterm infants (median gestation 25.7 weeks; birth weight 820 g) were randomised. Compared with M-FiO2, the time spent within TR was higher in the A-FiO2 group (68.7% vs 48.0%, p<0.001). Infants in the A-FiO2 group spent less time in hyperoxaemia (13.8% vs 37.7%, p<0.001), but no difference was found in hypoxaemia. The time-based analyses showed that the A-FiO2 efficacy may differ over time, especially for hypoxaemia. Compared with the M-FiO2 group, the A-FiO2 group had a larger intercept but with an inversed slope for the daily median area below the TR (intercept 70.1 vs 36.3; estimate/day -0.70 vs 0.69, p<0.001). CONCLUSION: A-FiO2 control was superior to manual control in keeping preterm infants on non-invasive respiratory support in a prespecified TR over a period of 28 days. This improvement may come at the expense of increased time below the TR in the first days after initiating A-FiO2 control. TRIAL REGISTRATION NUMBER: NTR6731.
- MeSH
- hypoxie prevence a kontrola MeSH
- klinické křížové studie MeSH
- kojenec MeSH
- kyslík * MeSH
- lidé MeSH
- novorozenec nedonošený * MeSH
- novorozenec MeSH
- porodní hmotnost MeSH
- Check Tag
- kojenec MeSH
- lidé MeSH
- novorozenec MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie 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.
OBJECTIVE: To perform a network meta-analysis of randomised controlled trials of different surfactant treatment strategies for respiratory distress syndrome (RDS) to assess if a certain fraction of inspired oxygen (FiO2) is optimal for selective surfactant therapy. DESIGN: Systematic review and network meta-analysis using Bayesian analysis of randomised trials of prophylactic versus selective surfactant for RDS. SETTING: Cochrane Central Register of Controlled Trials, MEDLINE, Embase and Science Citation Index Expanded. PATIENTS: Randomised trials including infants under 32 weeks of gestational age. INTERVENTIONS: Intratracheal surfactant, irrespective of type or dose. MAIN OUTCOME MEASURES: Our primary outcome was neonatal mortality, compared between groups treated with selective surfactant therapy at different thresholds of FiO2. Secondary outcomes included respiratory morbidity and major complications of prematurity. RESULTS: Of 4643 identified references, 14 studies involving 5298 participants were included. We found no statistically significant differences between 30%, 40% and 50% FiO2 thresholds. A sensitivity analysis of infants treated in the era of high antenatal steroid use and nasal continuous positive airway pressure as initial mode of respiratory support showed no difference in mortality, RDS or intraventricular haemorrhage alone but suggested an increase in the combined outcome of major morbidities in the 60% threshold. CONCLUSION: Our results do not show a clear benefit of surfactant treatment at any threshold of FiO2. The 60% threshold was suggestive of increased morbidity. There was no advantage seen with prophylactic treatment. Randomised trials of different thresholds for surfactant delivery are urgently needed to guide clinicians and provide robust evidence. PROSPERO REGISTRATION NUMBER: CRD42020166620.
- MeSH
- Bayesova věta MeSH
- lidé MeSH
- novorozenec nedonošený MeSH
- novorozenec MeSH
- plicní surfaktanty * terapeutické užití MeSH
- povrchově aktivní látky MeSH
- síťová metaanalýza MeSH
- syndrom respirační tísně novorozenců * farmakoterapie prevence a kontrola MeSH
- těhotenství MeSH
- Check Tag
- lidé MeSH
- novorozenec MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- metaanalýza MeSH
- systematický přehled MeSH
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.
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.
- MeSH
- jednotky intenzivní péče o novorozence MeSH
- klinické křížové studie MeSH
- kyslík terapeutické užití MeSH
- lidé MeSH
- neinvazivní ventilace MeSH
- novorozenec nedonošený * MeSH
- novorozenec MeSH
- oxygenoterapie metody MeSH
- oxymetrie metody MeSH
- syndrom respirační tísně novorozenců prevence a kontrola MeSH
- umělé dýchání metody MeSH
- ventilace umělá s přerušovaným přetlakem * MeSH
- Check Tag
- lidé MeSH
- novorozenec MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- randomizované kontrolované studie MeSH
OBJECTIVE: To determine whether restricting the use of inotrope after diagnosis of low blood pressure (BP) in the first 72 hours of life affects survival without significant brain injury at 36 weeks of postmenstrual age (PMA) in infants born before 28 weeks of gestation. DESIGN: Double-blind, placebo-controlled randomised trial. Caregivers were masked to group assignment. SETTING: 10 sites across Europe and Canada. PARTICIPANTS: Infants born before 28 weeks of gestation were eligible if they had an invasive mean BP less than their gestational age that persisted for ≥15 min in the first 72 hours of life and a cerebral ultrasound free of significant (≥ grade 3) intraventricular haemorrhage. INTERVENTION: Participants were randomly assigned to saline bolus followed by either a dopamine infusion (standard management) or placebo (5% dextrose) infusion (restrictive management). PRIMARY OUTCOME: Survival to 36 weeks of PMA without severe brain injury. RESULTS: The trial terminated early due to significant enrolment issues (7.7% of planned recruitment). 58 infants were enrolled between February 2015 and September 2017. The two groups were well matched for baseline variables. In the standard group, 18/29 (62%) achieved the primary outcome compared with 20/29 (69%) in the restrictive group (p=0.58). Additional treatments for low BP were used less frequently in the standard arm (11/29 (38%) vs 19/29 (66%), p=0.038). CONCLUSION: Though this study lacked power, we did not detect major differences in clinical outcomes between standard or restrictive approach to treatment. These results will inform future studies in this area. TRIAL REGISTRATION NUMBER: NCT01482559, EudraCT 2010-023988-17.
- MeSH
- dopamin aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- dvojitá slepá metoda MeSH
- gestační stáří MeSH
- hypotenze farmakoterapie mortalita MeSH
- kardiotonika aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- lidé MeSH
- novorozenci extrémně nezralí * MeSH
- novorozenec MeSH
- poranění mozku chemicky indukované MeSH
- Check Tag
- lidé MeSH
- novorozenec MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
Some neural circuits within infants are not fully developed at birth, especially in preterm infants. Therefore, it is unclear whether reflexes that affect breathing may or may not be activated during the neonatal stabilisation at birth. Both sensory reflexes (eg, tactile stimulation) and non-invasive ventilation (NIV) can promote spontaneous breathing at birth, but the application of NIV can also compromise breathing by inducing facial reflexes that inhibit spontaneous breathing. Applying an interface could provoke the trigeminocardiac reflex (TCR) by stimulating the trigeminal nerve resulting in apnoea and a reduction in heart rate. Similarly, airflow within the nasopharynx can elicit the TCR and/or laryngeal chemoreflex (LCR), resulting in glottal closure and ineffective ventilation, whereas providing pressure via inflations could stimulate multiple receptors that affect breathing. Stimulating the fast adapting pulmonary receptors may activate Head's paradoxical reflex to stimulate spontaneous breathing. In contrast, stimulating the slow adapting pulmonary receptors or laryngeal receptors could induce the Hering-Breuer inflation reflex or LCR, respectively, and thereby inhibit spontaneous breathing. As clinicians are most often unaware that starting primary care might affect the breathing they intend to support, this narrative review summarises the currently available evidence on (vagally mediated) reflexes that might promote or inhibit spontaneous breathing at birth.
- MeSH
- dýchání * MeSH
- fyzikální stimulace MeSH
- hmat MeSH
- hypotermie prevence a kontrola MeSH
- lidé MeSH
- neinvazivní ventilace přístrojové vybavení metody MeSH
- nervus vagus fyziologie MeSH
- novorozenec nedonošený fyziologie MeSH
- odsávání MeSH
- plíce fyziologie MeSH
- plicní ventilace MeSH
- primární zdravotní péče MeSH
- reflex * MeSH
- rizikové faktory MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- MeSH
- časové faktory MeSH
- elektrokardiografie normy MeSH
- kohortové studie MeSH
- lidé MeSH
- novorozenec MeSH
- srdeční frekvence fyziologie MeSH
- stetoskopy normy MeSH
- ultrasonografie přístrojové vybavení normy MeSH
- Check Tag
- lidé MeSH
- novorozenec MeSH
- Publikační typ
- časopisecké články MeSH
- pozorovací studie MeSH
- srovnávací studie MeSH
OBJECTIVE: Describe the likelihood of hypoxemia and hyperoxemia across ranges of oxygen saturation (SpO2), during mechanical ventilation with supplemental oxygenation. DESIGN: Retrospective observational study. SETTING: University affiliated tertiary care neonatal intensive care unit. PATIENTS: Two groups of neonates based on postmenstrual age (PMA): <32 weeks (n=104) and >36 weeks (n=709). MAIN MEASURES: Hypoxemia was defined as a PaO2 <40 mm Hg, hyperoxemia as a PaO2 of >99 mm Hg and normoxemia as a PaO2 of 50-80 mm Hg. Twenty-five per cent was defined as marked likelihood of hypoxemia or hyperoxemia. RESULTS: From these infants, 18 034 SpO2-PaO2 pairs were evaluated of which 10% were preterm. The PMA (median and IQR) of the two groups were: 28 weeks (27-30) and 40 weeks (38-41). With SpO2 levels between 90% and 95%, the likelihoods of hypoxemia and hyperoxemia were low and balanced. With increasing levels of SpO2, the likelihood of hyperoxemia increased. It became marked in the preterm group when SpO2 was 99%-100% (95% CI 29% to 41%) and in the term group with SpO2 levels of 96%-98% (95% CI 29% to 32%). The likelihood of hypoxemia increased as SpO2 decreased. It became marked in both with SpO2 levels of 80%-85% (95% CI 20% to 31%, 24% to 28%, respectively). CONCLUSIONS: The likelihood of a PaO2 <40 mm Hg is marked with SpO2 below 86%. The likelihood of a PaO2 >99 mm Hg is marked in term infants with SpO2 above 95% and above 98% in preterm infants. SpO2 levels between 90% and 95% are appropriate targets for term and preterm infants.
- MeSH
- gestační stáří MeSH
- hyperoxie krev diagnóza MeSH
- hypoxie krev diagnóza MeSH
- intenzivní péče o novorozence metody MeSH
- jednotky intenzivní péče o novorozence MeSH
- kyslík krev MeSH
- lidé MeSH
- nemoci nedonošenců krev diagnóza MeSH
- novorozenec nedonošený MeSH
- novorozenec MeSH
- oxymetrie metody MeSH
- parciální tlak MeSH
- retrospektivní studie MeSH
- Check Tag
- lidé MeSH
- novorozenec MeSH
- Publikační typ
- časopisecké články MeSH
- pozorovací studie MeSH
OBJECTIVE: To evaluate the amount of macronutrients in aggregate of human milk samples after preterm delivery during the first 2 months of lactation. METHODS: Analysis of the donated single milk samples, gained by complete emptying of the whole breast at the same daytime between 24+0 and 35+6 gestational age (GA), was designed as prospective observational cohort trial. Two milk samples were analysed every postnatal week up to the discharge from the hospital, week 9 or loss of lactation. 24-Hour milk collection was not done. Analysis was performed using the MIRIS Human Milk Analyser (MIRIS AB, Uppsala, Sweden). RESULTS: A set of 1917 human milk samples donated by 225 mothers after preterm labour was analysed. Group A (24-30 GA) contains 969 milk samples; group B (31-35 GA) contains 948 milk samples. No difference in milk composition between the groups was identified. Median of true protein content decreased from 1.6 g/dL in group A and 1.5 g/dL in group B in the first week of life, to 1.1 g/dL in both groups at the end of week 3, and then remained stable up to week 9. Content of carbohydrates and fat was stable during the whole observation, with interindividual differences. CONCLUSION: Human milk does not differ as a function of degree of prematurity. Protein content of preterm human milk is low and decreases during the first 3 weeks of lactation. Recommended daily protein intake cannot be achieved with routine fortification in majority of milk samples.
- MeSH
- gestační stáří * MeSH
- kojenec MeSH
- kojení MeSH
- lidé MeSH
- mateřské mléko chemie MeSH
- mléčné bílkoviny analýza MeSH
- novorozenec MeSH
- předčasný porod patologie MeSH
- prospektivní studie MeSH
- živiny analýza MeSH
- Check Tag
- kojenec MeSH
- lidé MeSH
- novorozenec MeSH
- Publikační typ
- časopisecké články MeSH
- pozorovací studie MeSH
