Wentylacja mechaniczna z zastosowaniem helioxu w leczeniu wcześniaków z zespołem zaburzeń oddychania

Objective: The aim of the study was to assess the influence of mechanical ventilation with helium-oxygen mixture (heliox) on basic vital signs, oxygenation, acid-base balance and respiratory mechanics in newborns with respiratory distress syndrome (RDS), previously treated with surfactant. Material and methods: The study was carried out in preterm newborns with respiratory failure requiring mechanical ventilation due to RDS, requiring FiO2≥0.4 after a single dose of surfactant. Patients were ventilated using PCSIMV. Parameters of mechanical ventilation, respiratory function, oxygenation, acid-base balance and vital signs were recorded at baseline, one hour during and one hour after heliox ventilation. Results: Ten newborns with RDS were enrolled in the study. Mechanical ventilation with heliox did not affect vital signs and patient general condition remained stable during and after ventilation with heliox. Mechanical ventilation with heliox was associated with a statistically significant increase in tidal volume (mean 5.48 vs 6.55 ml/kg). There were no significant changes in minute ventilation and peak expiratory flow rate. Mechanical ventilation with heliox allowed the use of significantly lower fractions of inspired oxygen (mean 0.55 vs 0.35), with a significant decrease in the oxygenation index (mean 8.77 vs 5.02) and alveolar-arterial oxygen tension difference (mean 63.81vs113.28 mm Hg). After ventilation with this gas mixture was stopped, the patients required higher FiO2, OI and AaDO2 levels increased. Conclusions: Mechanical ventilation with heliox was safe, improved oxygenation and caused an increase in tidal volume in newborns with RDS previously treated with surfactant.Cel pracy: Ocena wpływu wentylacji mechanicznej z zastosowaniem helioxu (mieszaniny tlenu i helu) na postawowe parametry życiowe, utlenowanie, równowagę kwasowo-zasadową oraz wybrane elementy mechaniki oddychania u wcześniaków z ZZO leczonych uprzednio surfaktantem. Materiał i metody: Badanie przeprowadzono u wcześniaków z niewydolnością oddechową w przebiegu zespołu zaburzeń oddychania (ZZO), u których pomimo podania 1 dawki surfaktantu utrzymywało się podwyższone zapotrzebowanie na tlen (stężenie tlenu w mieszaninie oddechowej (FiO2 ) ≥0.4). Pacjenci byli wentylowani mechanicznie z wykorzystaniem trybu PC-SIMV. Parametry wentylacji, funkcji płuc, utlenowania, równowagi kwasowo-zasadowej i podstawowe parametry życiowe były rejestrowane na początku badania, następnie w ciągu godziny wentylacji helioxem oraz 1 godzinę po jej zakończeniu. Wyniki: Do badania włączono 10 noworodków z ZZO. Wentylacja helioxem nie miała wpływu na podstawowe parametry życiowe i stan ogólny pacjentów, który podczas stosowania helioxu oraz po jego zakończeniu pozostawał stabilny. Wentylacja mechaniczna z zastosowaniem helioxu wiązała się ze statystycznie istotnym zwiększeniem objętości oddechowych (5.48 vs 6.55 ml/kg; wartości średnie). Nie wystąpiły istotne zmiany w zakresie wentylacji minutowej i szczytowego przepływu końcowo-wydechowego. Wentylacja helioxem umożliwiła użycie istotnie niższych stężeń tlenu w mieszaninie oddechowej (0.55 vs 0.35), z jednoczesnym obniżeniem wskaźnika utlenowania (8.77 vs 5.02) i pęcherzykowo-tętniczej różnicy prężności tlenu (263.81 vs 113.28 mm Hg). Po zakończeniu wentylacji tą mieszaniną gazów pacjenci wymagali wyższego FiO2, a wartości OI i AaDO2 wzrosły. Wnioski: Wentylacja mechaniczna helioxem była bezpieczna, spowodowała poprawę utlenowania oraz zwiększenie objętości oddechowych u noworodków z ZZO leczonych surfaktantem

Evaluation of stress responses in parents of newborns hospitalized in the Intensive Care Unit

Summary Aim: To analyze the results of an investigation about the influence of newborn hospitalization at the Neonatal Intensive Care Unit on emotional status of the parents. Material and methods: The survey was conducted among 98 parents of the newborns hospitalized in the NICU with the use of the PPS-NICU questionnaire. The questionnaire included potential stress factors such as ward environment, treatment procedures as well as the role of the parents in such circumstances. Results: Factors causing the most severe parental stress proved to be: respiratory distress of the newborn, the necessity of mechanical ventilatory support and vital signs monitor alarm activation. Differences in stress levels between mothers and fathers were presented on the basis of their own estimation of the relationship with the child and understanding of their individual parental roles. Conclusions: Results of the study indicate that it is possible to decrease the stress level among parents of the NICU patients by explaining the background of the disease, the current clinical condition of the newborn, the necessity of diagnostic and treatment procedures and involving the parents in the basic care of the newborn

Opinion Paper: Rationale for Supra-National Training in Neonatology

Introduction: Clinical training in neonatology takes place where neonates are cared for, at the cot-side, in neonatal units. Neonatal units vary widely in size, specialization, resources, staffing and academic level. Among them, small units make up a large proportion which have more difficulties to offer structured training courses on site, local expertise on all relevant neonatal topics, and appropriate exposition of the trainee to high-risk cases. Although evidence-based medicine is widely accepted, training of physicians, including neonatologists, often follows ineffective learning methods, or even less favorable, learning by doing. When looking at the national training requirements and standards within Europe, there are large differences between countries. Some countries have training requirements, standards and national training courses in place other countries have none of this. Therefore, it is worthwhile to create a supra-regional or even supra-national training program that complements local clinical work on an individual basis to provide structured training and evidence-based education anywhere and anytime. The European Society for Paediatric Research (ESPR) has long been committed to the education and training of medical doctors specializing in neonatology. Together with the European Board of Neonatology (EBN), which is a substructure of ESPR devoted to the design and implementation of a syllabus that comprises the theoretical and practical needs for the European Training in Neonatology, the European Training Requirements (ETR) in Neonatology has been developed. The 2021 updated syllabus, the current ETR in Neonatology, is based on the previous 2007 syllabus version and has been approved by the Union of European Medicine Specialist (EAMS) in April 2021. Interestingly, the 2021 syllabus content was updated by the EBN members, but also critically incorporated and comments suggestions of national representatives of 30 European countries following two sequential surveys and face to face meetings. Each country pertaining to the EBN has a different national training curriculum to achieve the training standards required to exert as neonatologists. The aim of the ETR in Neonatology has been to harmonize training requirements within Europe to achieving a basic and reliable standard of quality in theoretical knowledge and practical skills alongside the European countries. We present an online training concept that meets the needs of neonatal training situations and implements the latest effective didactic elements

Do abnormal results of Doppler examinations in fetuses with growth restriction increase the frequency of postnatal complications of the central nervous system and gastrointestinal tract?

Abstract Objectives: The aim of the work was to assess the correlations between the results of antenatal Doppler examinations in fetuses with growth restriction (IUGR) and the frequency of postnatal complications of central nervous system and gastrointestinal tract. Material and methods: 47 pregnant women and 47 fetuses and newborns from singleton pregnancies with diagnosed intrauterine growth restriction. Two groups of fetuses (newborns) were distinguished based on serial Doppler examinations of fetal umbilical and middle cerebral arteries: 1) newborns with IUGR and abnormal results of antenatal Doppler examinations (group 1); 2) newborns with IUGR and normal results of antenatal Doppler examinations (group 2). The analysis concerned such neonatal complications as intraventricular hemorrhages (IVH) of III and IV degree, leucomalacias and necrotizing eneterocollits (NEC). Results: Among 47 neonates, the abnormal results of Doppler examinations were found in 21 of them, and in the rest of the newborns (26) there were no abnormalities in Doppler antenatal examinations. The frequency of intraventricular hemorrhages of III and IV degree, neonatal leucomalacias and necrotizing eneterocollits did not differ significantly between the groups. The mean time of hospitalization in newborns with abnormal results of antenatal Doppler examinations was significantly longer than in neonates whose antenatal Doppler tests were normal (14 days vs 10 days). The newborns from group 1 required parenteral feeding significantly more often than the newborns from group 2 (28,9% vs 12%). Conclusions: The comparable frequency of central nervous system complications in newborns with abnormal and in neonates with normal results of antenatal Doppler examinations may indicate on effective role of brain sparing effect in fetuses with IUGR as a mechanism which reduces the likelihood of hypoxemic complications in the developing fetal brain. The newborns with IUGR and abnormal results of antenatal Doppler test require both a longer hospitalization and the necessity of parenteral feeding when compared with newborns with IUGR and normal antenatal Doppler test results. Newborns who were diagnosed with absent or reversed end-diastolic flow in umbilical artery are particularly at risk of central nervous system complications

Opinion paper: rationale for supra-national training in neonatology

Clinical training in neonatology takes place where neonates are cared for, at the cot-side, in neonatal units. Neonatal units vary widely in size, specialization, resources, staffing and academic level. Among them, small units make up a large proportion which have more difficulties to offer structured training courses on site, local expertise on all relevant neonatal topics, and appropriate exposition of the trainee to high-risk cases. Although evidence-based medicine is widely accepted, training of physicians, including neonatologists, often follows ineffective learning methods, or even less favorable, learning by doing. When looking at the national training requirements and standards within Europe, there are large differences between countries. Some countries have training requirements, standards and national training courses in place other countries have none of this. Therefore, it is worthwhile to create a supra-regional or even supra-national training program that complements local clinical work on an individual basis to provide structured training and evidence-based education anywhere and anytime. The European Society for Paediatric Research (ESPR) has long been committed to the education and training of medical doctors specializing in neonatology. Together with the European Board of Neonatology (EBN), which is a substructure of ESPR devoted to the design and implementation of a syllabus that comprises the theoretical and practical needs for the European Training in Neonatology, the European Training Requirements (ETR) in Neonatology has been developed. The 2021 updated syllabus, the current ETR in Neonatology, is based on the previous 2007 syllabus version and has been approved by the Union of European Medicine Specialist (EAMS) in April 2021. Interestingly, the 2021 syllabus content was updated by the EBN members, but also critically incorporated and comments suggestions of national representatives of 30 European countries following two sequential surveys and face to face meetings. Each country pertaining to the EBN has a different national training curriculum to achieve the training standards required to exert as neonatologists. The aim of the ETR in Neonatology has been to harmonize training requirements within Europe to achieving a basic and reliable standard of quality in theoretical knowledge and practical skills alongside the European countries. We present an online training concept that meets the needs of neonatal training situations and implements the latest effective didactic elements

The effects of cerebral oximetry in mechanically ventilated newborns: a protocol for the SafeBoosC-IIIv randomised clinical trial

Background The SafeBoosC project aims to test the clinical value of non-invasive cerebral oximetry by near-infrared spectroscopy in newborn infants. The purpose is to establish whether cerebral oximetry can be used to save newborn infants’ lives and brains or not. Newborns contribute heavily to total childhood mortality and neonatal brain damage is the cause of a large part of handicaps such as cerebral palsy. The objective of the SafeBoosC-IIIv trial is to evaluate the benefits and harms of cerebral oximetry added to usual care versus usual care in mechanically ventilated newborns. Methods/design SafeBoosC-IIIv is an investigator-initiated, multinational, randomised, pragmatic phase-III clinical trial. The inclusion criteria will be newborns with a gestational age more than 28 + 0 weeks, postnatal age less than 28 days, predicted to require mechanical ventilation for at least 24 h, and prior informed consent from the parents or deferred consent or absence of opt-out. The exclusion criteria will be no available cerebral oximeter, suspicion of or confirmed brain injury or disorder, or congenital heart disease likely to require surgery. A total of 3000 participants will be randomised in 60 neonatal intensive care units from 16 countries, in a 1:1 allocation ratio to cerebral oximetry versus usual care. Participants in the cerebral oximetry group will undergo cerebral oximetry monitoring during mechanical ventilation in the neonatal intensive care unit for as long as deemed useful by the treating physician or until 28 days of life. The participants in the cerebral oximetry group will be treated according to the SafeBoosC treatment guideline. Participants in the usual care group will not receive cerebral oximetry and will receive usual care. We use two co-primary outcomes: (1) a composite of death from any cause or moderate to severe neurodevelopmental disability at 2 years of corrected age and (2) the non-verbal cognitive score of the Parent Report of Children’s Abilities-Revised (PARCA-R) at 2 years of corrected age. Discussion There is need for a randomised clinical trial to evaluate cerebral oximetry added to usual care versus usual care in mechanically ventilated newborns. Trial registration The protocol is registered at www.clinicaltrials.gov (NCT05907317; registered 18 June 2023)

Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants:A protocol for the SafeBoosC randomised clinical phase III trial

Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials. The objective of the SafeBoosC III trial is to investigate the benefits and harms of treatment based on near-infrared spectroscopy (NIRS) monitoring compared with treatment as usual for extremely preterm infants

Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial.

BACKGROUND: Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials. The objective of the SafeBoosC III trial is to investigate the benefits and harms of treatment based on near-infrared spectroscopy (NIRS) monitoring compared with treatment as usual for extremely preterm infants. METHODS/DESIGN: SafeBoosC III is an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. Inclusion criteria will be infants born below 28 weeks postmenstrual age and parental informed consent (unless the site is using 'opt-out' or deferred consent). Exclusion criteria will be no parental informed consent (or if 'opt-out' is used, lack of a record that clinical staff have explained the trial and the 'opt-out' consent process to parents and/or a record of the parents' decision to opt-out in the infant's clinical file); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6 h after birth. Participants will be randomised 1:1 into either the experimental or control group. Participants in the experimental group will be monitored during the first 72 h of life with a cerebral NIRS oximeter. Cerebral hypoxia will be treated according to an evidence-based treatment guideline. Participants in the control group will not undergo cerebral oxygenation monitoring and will receive treatment as usual. Each participant will be followed up at 36 weeks postmenstrual age. The primary outcome will be a composite of either death or severe brain injury detected on any of the serial cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age. Severe brain injury will be assessed by a person blinded to group allocation. To detect a 22% relative risk difference between the experimental and control group, we intend to randomise a cohort of 1600 infants. DISCUSSION: Treatment guided by cerebral NIRS oximetry has the potential to decrease the risk of death or survival with severe brain injury in preterm infants. There is an urgent need to assess the clinical effects of NIRS monitoring among preterm neonates. TRIAL REGISTRATION: ClinicalTrial.gov, NCT03770741. Registered 10 December 2018

Extremely Preterm Infant Admissions Within the SafeBoosC-III Consortium During the COVID-19 Lockdown

Objective: To evaluate if the number of admitted extremely preterm (EP) infants (born before 28 weeks of gestational age) differed in the neonatal intensive care units (NICUs) of the SafeBoosC-III consortium during the global lockdown when compared to the corresponding time period in 2019. Design: This is a retrospective, observational study. Forty-six out of 79 NICUs (58%) from 17 countries participated. Principal investigators were asked to report the following information: (1) Total number of EP infant admissions to their NICU in the 3 months where the lockdown restrictions were most rigorous during the first phase of the COVID-19 pandemic, (2) Similar EP infant admissions in the corresponding 3 months of 2019, (3) the level of local restrictions during the lockdown period, and (4) the local impact of the COVID-19 lockdown on the everyday life of a pregnant woman. Results: The number of EP infant admissions during the first wave of the COVID-19 pandemic was 428 compared to 457 in the corresponding 3 months in 2019 (−6.6%, 95% CI −18.2 to +7.1%, p = 0.33). There were no statistically significant differences within individual geographic regions and no significant association between the level of lockdown restrictions and difference in the number of EP infant admissions. A post-hoc analysis based on data from the 46 NICUs found a decrease of 10.3%in the total number of NICU admissions (n = 7,499 in 2020 vs. n = 8,362 in 2019). Conclusion: This ad hoc study did not confirm previous reports of a major reduction in the number of extremely pretermbirths during the first phase of the COVID-19 pandemic. Clinical Trial Registration: ClinicalTrial.gov, identifier: NCT04527601 (registered August 26, 2020), https://clinicaltrials.gov/ct2/show/NCT04527601

Implementation of less invasive surfactant administration in clinical practice-Experience of a mid-sized country.

OBJECTIVE:There are differences in the adoption rates of less invasive surfactant administration (LISA) worldwide. We aimed to describe and analyze the process of LISA introduction at the country level. METHODS:A standardized training program (33 courses covering >500 neonatologists) was followed by a cohort study. Data regarding consecutive LISA procedures were acquired over 12 months in 31 tertiary neonatal centers, using a dedicated on-line platform. RESULTS:Of 500 LISA procedures, 75% were performed by specialists and 25% by residents. The mean percentage share of LISA in all surfactant therapies was 24%, which represents a 6-fold increase compared to previous years. After 12 months, 76% of the procedures were rated "easy/very easy" vs 59% at baseline (p<0.05). Surfactant re-treatment rate was 15%. Twenty-three percent of infants required mechanical ventilation within 72 hours of life. Oxygen desaturation and surfactant reflux were the most frequent complications. Unlike previous reports describing exclusive use of nasal continuous positive airway pressure (nCPAP) during LISA, majority of procedures (63%) were carried out using nasal intermittent positive pressure ventilation (NIPPV) or Bilevel Positive Airway Pressure (BiPAP). Efficacy of LISA with NIPPV or BiPAP was not significantly different from that with nCPAP (22.4% vs 24.5% of cases requiring intubation). Ventilation was provided with nasal cannulas or nasal masks (90%) and rarely with "RAM" cannulas or nasopharyngeal tubes. Rigid catheters were preferred (88.4%); tracheal insertion was successful at first attempt in 87% of cases. Majority of infants (79%) received no premedication prior to the procedure and almost all were given caffeine citrate. Median time of instillation was 1.5 minutes. CONCLUSIONS:The LISA procedure does not appear to be technically difficult to master. Training combining theory with practical exercises is an efficient implementation strategy. Variations in adoption rates indicate the need for additional, more personalized teachings in some centers