Evaluation of two SpO2 alarm strategies during automated FiO2 control in the NICU: a randomized crossover study.

BACKGROUND: Changes in oxygen saturation (SpO2) exposure have been shown to have a marked impact on neonatal outcomes and therefore careful titration of inspired oxygen is essential. In routine use, however, the frequency of SpO2 alarms not requiring intervention results in alarm fatigue and its corresponding risk. SpO2 control systems that automate oxygen adjustments (Auto-FiO2) have been shown to be safe and effective. We speculated that when using Auto-FiO2, alarm settings could be refined to reduce unnecessary alarms, without compromising safety. METHODS: An unblinded randomized crossover study was conducted in a single NICU among infants routinely managed with Auto-FiO2. During the first 6 days of respiratory support a tight and a loose alarm strategy were switched each 24 h. A balanced block randomization was used. The tight strategy set the alarms at the prescribed SpO2 target range, with a 30-s delay. The loose strategy set the alarms 2 wider, with a 90-s delay. The effectiveness outcome was the frequency of SpO2 alarms, and the safety outcomes were time at SpO2 extremes (< 80, > 98%). We hypothesized that the loose strategy would result in a marked decrease in the frequency of SpO2 alarms, and no increases at SpO2 extremes with 20 subjects. Within subject differences between alarm strategies for the primary outcomes were evaluated with Wilcoxon signed-rank test. RESULTS: During a 13-month period 26 neonates were randomized. The analysis included 21 subjects with 49 days of both tight and loose intervention. The loose alarm strategy resulted in a reduction in the median rate of SpO2 alarms from 5.2 to 1.6 per hour (p <  0.001, 95%-CI difference 1.6-3.7). The incidence of hypoxemia and hyperoxemia were very low (less than 0.1%-time) with no difference associated with the alarm strategy (95%-CI difference less than 0.0-0.2%). CONCLUSIONS: In this group of infants we found a marked advantage of the looser alarm strategy. We conclude that the paradigms of alarm strategies used for manual titration of oxygen need to be reconsidered when using Auto-FiO2. We speculate that with optimal settings false positive SpO2 alarms can be minimized, with better vigilance of clinically relevant alarms. TRIAL REGISTRATION: Retrospectively registered 15 May 2018 at ISRCTN ( 49239883 ).

[Parents avoiding child vaccination in the neonatal period - an analysis of attitudes].

OBJECTIVE: Parents' avoidance of vaccination is a growing phenomenon and leads to the deterioration of the epidemiological situation regarding diseases included in active prevention programs. The aim of the study was to analyze the attitudes of parents who avoid vaccination in newborns. PATIENTS AND METHODS: Material and methods: The study included parents who refused to perform vaccination in theirnewborn. A survey analyzing the attitudes of parents avoiding vaccination in newborns was performed in a tertiary referral hospital in the years 2015-2017. We gathered information concerning their demographic data, comprising the reasons for their decision, information sources and the implementation of vaccination in a child after six months.. RESULTS: Results: We observed an increase in the number of parents avoiding vaccination in the years 2015-2017 (1.58%, 2.54%, 2.83% respectively). The parents were mature (age 31.5-34.5 years), usually with university education (93%). 63% had more than one child. In large families, 67% of the parents had vaccinated their older children. The lack of honest medical information from the personnel, negative opinions from the Internet and other parents were the reasons for avoiding vaccination. CONCLUSION: Conclusions: The insufficient activity of the medical personnel and the strong influence of anti-vaxxers' opinions, which is easily accessible on social media, are the reasons for the nonoptimal implementation of the vaccination program. It is necessary to spread honest knowledge about the epidemiological threats concerning vaccine-preventable diseases and develop a skillful way of distributing it through all the possible ways of communication.

Risk factors for adverse events after vaccinations performed during the initial hospitalization of infants born prematurely.

INTRODUCTION: There are significant delays in implementing vaccination among preterm infants. OBJECTIVES: Description of the frequency and kinds of adverse events following immunization in preterms. Establishment of the group of preterms who will distinctively be susceptible to adverse events. MATERIALS AND METHODS: Demographical, clinical data and the occurrence of adverse events after DTaP, HIB and pneumococcal vaccination among preterms during their initial hospitalization were prospectively collected with the use of an electronic data form between 1st June 2011 and 31st May 2015. The analysis was conducted on 138 patients. The groups were divided according to maturity (I: ≤ GA 28w n=73 and GA 29-36 w n=65). RESULTS: There were no statistically significant differences between the groups in the occurrence of adverse events. Out of the total group, following vaccination apnoea developed in 6 newborns (4%) and activity dysfunctions were observed in 13 newborns (10%). The occurrence of apnoea after vaccination positively correlated with the time of non-invasive ventilation and the occurrence of late infection. There were no statistically significant demographical or clinical risk factors for the development of activity dysfunctions following vaccination. CONCLUSIONS: Term vaccination in clinically stable preterm infants is a safe medical procedure. However, long-term non-invasive respiratory support and late infections are risk factors for apnea following vaccinations. In these patients vaccinations should be considered during hospitalization.

Automated versus Manual Oxygen Control with Different Saturation Targets and Modes of Respiratory Support in Preterm Infants.

OBJECTIVE: To determine the efficacy and safety of automated adjustment of the fraction of inspired oxygen (FiO2) in maintaining arterial oxygen saturation (SpO2) within a higher (91%-95%) and a lower (89%-93%) target range in preterm infants. STUDY DESIGN: Eighty preterm infants (gestational age [median]: 26 weeks, age [median] 18 days) on noninvasive (n = 50) and invasive (n = 30) respiratory support with supplemental oxygen, were first randomized to one of the SpO2 target ranges and then treated with automated FiO2 (A-FiO2) and manual FiO2 (M-FiO2) oxygen control for 24 hours each, in random sequence. RESULTS: The percent time within the target range was higher during A-FiO2 compared with M-FiO2 control. This effect was more pronounced in the lower SpO2 target range (62 ± 17% vs 54 ± 16%, P < .001) than in the higher SpO2 target range (62 ± 17% vs 58 ± 15%, P < .001). The percent time spent below the target or in hypoxemia (SpO2 <80%) was consistently reduced during A-FiO2, independent of the target range. The time spent above the target range or at extreme hyperoxemia (SpO2 >98%) was only reduced during A-FiO2 when targeting the lower SpO2 range (89%-93%). These outcomes did not differ between infants on noninvasive and invasive respiratory support. Manual adjustments were significantly reduced during A-FiO2 control. CONCLUSIONS: A-FiO2 control improved SpO2 targeting across different SpO2 ranges and reduced hypoxemia in preterm infants on noninvasive and invasive respiratory support. TRIAL REGISTRATION: ISRCTN 56626482.

USING THE AUTOMATED FIO2- SPO2 CONTROL IN NEONATAL INTENSIVE CARE UNITS IN POLAND. A PRELIMINARY REPORT.

AIM: Analysis of the way in which a new method of implementing the automated control of oxygen therapy during respiratory support is applied in newborns with respiratory failure. MATERIAL, METHODS AND RESULTS: The AVEA-CLiO2 ventilator with automated FiO2- SpO2 control was used in our study of 121 newborns conducted between February 2014 and January 2015 in five neonatal intensive care units. A web-based database was used to gather information entered concurrently with using the FiO2- SpO2 control system. This included demographics, clinical status, clinical indications, as well as objective and subjective experience. Among the 121 newborns 94 were preterm and 27 were near-term (33-36 hbd). The primary indication for using the system was "routine management" of FiO2 during respiratory support and it was generally initiated within the first 2 days of life. Many of the newborns were managed with the system for more than a week. The control range was usually 90%-95% SpO2, though sometimes it was lower or wider. The control range was not related to the newborn's maturity or indication for use. The perception of more "frequent and persistent" SpO2 alarms was lower when the alarms were set loosely. There were no reports of the system not working effectively. CONCLUSIONS: We expect this first report of the routine use of automated FiO2- SpO2 control to be useful not only to other centers in Poland but also to all those adopting this important new technology. Our registry continues and we expect to have an update when we have experience with 1000 infants. Carefully controlled trials are also needed to refine the optimum use of automated FiO2- SpO2 control and to quantify its impact on neonatal outcomes.