BACKGROUND:The most effective and safe level of positive end-expiratory pressure (PEEP) during stabilisation at birth of extremely preterm infants is unknown. In observational studies, an initial high PEEP level, then titrated to response (dynamic PEEP strategy), improved clinically relevant outcomes compared with current practice using a static, and lower, PEEP level. The Positive End-Expiratory Pressure Levels during Resuscitation of Preterm Infants at Birth (POLAR) trial will evaluate a novel dynamic PEEP strategy at birth. METHODS:In an international multicentre prospective open-label randomised controlled trial, we will randomise extremely preterm infants who require respiratory support from birth to either dynamic PEEP or a static PEEP. The primary outcomes are death or bronchopulmonary dysplasia at 36 weeks' postmenstrual age. The experimental intervention of a dynamic PEEP strategy commences at 8 cmH2O, but individualised to clinical need to a maximum PEEP 12 cmH2O during stabilisation in the delivery room. The control arm is a standard, static PEEP (5-6 cmH2O). Important short-term respiratory morbidity and potential harm outcomes in the first 10 days after birth are pre-specified secondary outcomes. TRIAL REGISTRATION:www. CLINICALTRIALS:gov , Trial Identifier NCT04372953, Registered 4 May 2020. IMPACT:The most effective and safe level of positive end-expiratory pressure (PEEP) during stabilisation at birth of extremely preterm infants remains unknown. The international multicentre randomised controlled Positive End-Expiratory Pressure Levels during Resuscitation of Preterm Infants at Birth (POLAR) trial is designed to evaluate a novel dynamic PEEP strategy. The POLAR Trial will compare starting at 8 cmH2O PEEP at birth, then titrated between 8 and 12 cmH2O to response, against a static, lower, 6 cmH2O PEEP reflecting current practice. We plan to recruit 906 extremely preterm infants from birth. Reducing death or bronchopulmonary dysplasia (primary outcome) would represent a major advance in neonatal care.
Beside technical skills, also cognitive processes and communication may influence newborn transition. We evaluate whether team leader’s visual attention (VA) to areas of interest (AOI) correlates with experience and communication patterns in the delivery room management of newborn babies. Observational study using eye-tracking glasses (Tobii Pro®) in seventeen neonatal transitions. VA: fixations, fixation time, dwell time, visits; AOI: infant’s head, chest, monitor, resuscitation bay, healthcare providers (HCP), elsewhere. Communication: direct, closed-loop, inclusive leader and speaking up. Data were analyzed in Period 1: 0–1 min, Period 2: 2–5 min, Period 3: 6–10 min after birth. VA shifted over time from infant’s head to chest to an even distribution. In Period 1, team leaders focused predominantly on the infant’s head (24.0
To analyze neurodevelopmental outcome of children born very preterm (born 2012 to 2018) aged 5 years in Vorarlberg, Austria. To identify medical risk factors and compare with (inter)national data. In this population-based study with prospectively collected data very preterm children underwent neurodevelopmental assessment: Kaufman Assessment Battery for Children (KABC-II) for cognitive functioning, Movement Assessment Battery for Children (M-ABC-2) for motor skills, Strengths and Difficulties Questionnaire (SDQ) and Behavior Rating Inventory of Executive Function – Preschool Version (BRIEF-P) for deficits in behavior and executive functions. Risk factors were identified using multiple linear regression. The study population (n = 114, 46.5% completed follow-up) showed moderate to severe neurodevelopmental disability (KABC-II IQ score <70), mild (KABC-II IQ score 70–84, M-ABC-2 total score <7, SDQ total score >90th percentile or BRIEF-P Global Executive Function score T >65), and no neurodevelopmental disability in 2.9, 31.4, and 65.7% of the children, respectively. Results were more disadvantageous for children born extremely preterm than for very preterm born children. Regarding risk factors, abnormal hearing screening, male gender, and ICH grades 3–4 were associated with poorer cognitive and motor skills. In our state-wide cohort of very preterm children, we observed a small proportion of moderate to severe neurodevelopmental disabilities of 2.9%, whereby 65.7% had no disability at 5 years. Disadvantageous outcomes are more pronounced in extremely preterm children.
BACKGROUND:Delivery room trials face ethical and logistical enrolment challenges, including requirements for prospective, antenatal, parental consent. The Sustained Aeration of Infant Lungs (SAIL) study was a randomised controlled trial of two resuscitation strategies at birth, enrolling infants using both prospective antenatal consent and deferred postnatal (consent-to-continue) pathways. We aimed to compare recruitment and outcomes between SAIL trial centres with deferred consent available versus centres only using prospective antenatal consent. METHOD:This study is a secondary analysis of the data from the open-label, international, multicentre, randomised SAIL trial. Infants born at 23 to less than 27 weeks' gestation at 18 centres across nine countries who were deemed to require intermittent positive pressure ventilation due to inadequate respiratory efforts or bradycardia, had no known major congenital anomalies, and were neither stillborn nor considered to be non-viable by their clinician were eligible for inclusion. Centres were compared by consent mode availability: antenatal consent only versus centres with deferred consent available. The primary outcome was the combined rate of death or bronchopulmonary dysplasia compared between consent type groups. People with lived experience did not contribute to the design or implementation of the SAIL trial. The SAIL trial was registered with ClinicalTrials.gov (NCT02139800). FINDINGS:The SAIL trial recruited 426 infants (222 [52%] were male and 204 [48%] were female) born from 371 mothers (218 [59%] were White) between Aug 27, 2014, and Sept 14, 2017. In 12 centres using only antenatal consent, 197 (41%) of 479 eligible infants were recruited and included in analysis compared with 229 (73%) of 313 eligible infants from six centres where deferred consent was available (with or without antenatal consent; absolute difference 31·78% [95% CI 24·46-39·10; p<0·0001]). Deferred consent was not obtained from 34 (15%) of 225 infants randomly assigned via the deferred pathway, who were excluded from this analysis. Compared with centres using only antenatal consent, infants recruited at deferred consent centres had less exposure to antenatal corticosteroids (166 [84%] of 197 vs 167 [73%] of 229 infants, p=0·012); were more likely to be male (88 [45%] vs 134 [59%], p=0·0065); were heavier (median birthweight 687 g [IQR 558-817] vs 767 g [661-870], p<0·0001); were less likely to be growth restricted (34 [27%] vs 19 [8%], p=0·0075); and less frequently intubated at birth (125 [63%] vs 105 [46%], p=0·0005). The rate of death or bronchopulmonary dysplasia at deferred consent centres was 65% (149/229) versus 57% (113/197) at antenatal consent centres (adjusted relative risk 1·18 [95% CI 0·98-1·42]). INTERPRETATION:Centres where deferred consent was available recruited a higher proportion of eligible infants at high risk who had more morbidities, reflecting a broader, more generalisable sample of the population compared with centres that only recruited using antenatal consent. FUNDING:Eunice Kennedy Shriver National Institute of Child Health and Human Development.
The assessment of the newborn after birth is fundamental for identifying those requiring resuscitation. Certain components of the Apgar score are used to assess neonatal condition, but their value is insufficiently validated. We aimed to identify the components of the Apgar score that predict neonatal resuscitation. Individual patient data from two multicenter trials were analyzed. Preterm newborns under 32 weeks of gestation and term newborns with perinatal acidosis and/or resuscitation were included. The extent of resuscitation was quantified by a standardized scoring system, and the clinical condition was quantified by a specified Apgar score. Correlation, linear regression and ROC analyses were used to address the study question. A total of 2093 newborns were included. Newborns in poor clinical condition at 1 min received more interventions at 5 and 10 min. Heart rate, muscle tone, reflexes and breathing quality, but not skin color, were moderately strong correlated with the extent of resuscitation at 5 (r = 0.44 to 0.52) and 10 min (r = 0.38 to 0.42). Heart rate, reflexes and chest movement at 1 min best predicted the subsequent need for resuscitation (R2 = 0.31). The rare interventions of intubation, chest compressions and epinephrine administration can be predicted by the newborn’s condition at one minute, with a high sensitivity of 84
In general, the battery-related emergency department visit rate has continued to rise in the last decade. We present two cases of previously healthy toddlers (14 and 24 months old) with unwitnessed battery ingestion, who presented with massive, hematocrit-relevant hematemesis. Initially, both children showed stable vital signs. Following a symptom-free interval, both had a recurrence of massive hematemesis, which could not be controlled despite a multidisciplinary approach with pediatric, radiology, ENT specialists, endoscopy and anesthesia. Pathological workup showed necrosis with secondary aortoesophageal fistula due to battery-induced colliquation necrosis caused by caustic soda produced at the minus pole. We conclude, that preclinical risk scores, excellent clinical pathways (e.g., from Children's Hospital of Philadelphia) and detailed approaches from the National Capital Poison Center in the USA and also the European Society of Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) offer clear and concise instructions for the management of button battery ingestion, but clinical awareness for vascular complications must be heightened. A multidisciplinary treatment algorithm for this fatal complication should be implemented and trained in pertinent hospitals. Moreover, it is of great importance to raise awareness for button battery ingestion in educational campaigns for parents and caregivers.
Die österreichische Empfehlung zum Vorgehen bei extrem unreifen Frühgeborenen an der Grenze der Lebensfähigkeit wurde zuletzt 2017 aktualisiert und empfahl unter anderem in SSW 220–6 aufgrund extrem niedriger Überlebensraten einen primär palliativen Behandlungsansatz. Zwischenzeitlich wurden aus verschiedenen Ländern und Institutionen Daten veröffentlicht, die ein deutlich verbessertes, über 50
AimTo determine short-term morbidity and mortality rates in the first state-wide Austrian neonatal cohort and comparison to (inter)national data.MethodsObservational, population-based cohort study, analyzing data of preterm infants (<32 + 0 weeks of gestation) born between 2007 and 2020 (n = 501) in an Austrian state who were admitted to the neonatal intensive care unit. Outcome criteria were mortality, neonatal morbidities: bronchopulmonary dysplasia (BPD), severe necrotizing enterocolitis (NEC), severe intraventricular hemorrhage (IVH grades III–IV), severe retinopathy of prematurity (ROP grades III–V) and survival-free of major complications.ResultsOverall survival rate was 95%, survival free of major complications was 79%. Prevalence for BPD was 11.2%, surgical NEC 4.0%, severe IVH 4.6%, and for severe ROP 2.6%, respectively. In the extremely low gestational age neonates (ELGAN) born <28 weeks of gestation (n = 158), survival was 88% and survival free of major complications 58.8%. Over time, mortality decreased significantly, predominantly driven by the improvement of infants born <28 week of gestation and survival free of major complications improved.ConclusionsThis study demonstrates a very low mortality rate that decreases over time. Short-term morbidities and survival free of major complications do not differ from (inter)national data in a similar group of very preterm infants. Standard operating procedures, simulation trainings and accordance to international trials may improve patient care and surpass center case loads.
AIM:Associations between serum biomarkers S100 calcium-binding protein B (S100B) and neuron-specific enolase (NSE) in neonates with hypoxic-ischaemic encephalopathy (HIE) offer contradicting data in regard to neurocognitive outcome. The aim of our study was to provide another dataset to answer this question if S100B or NSE correlates to outcome in neonatal HIE. In addition, we investigate whether amplitude-integrated EEG (aEEG) or magnetic resonance imaging (MRI) also has predictive value. METHODS:In neonates with HIE born in Vorarlberg, Austria, (n = 34) from 2012to 2020, NSE and S100B serum levels were measured on day one. aEEG was installed at admission and MRI performed within 7 days. Surviving children (n = 27) were categorised as good or poor outcome by using an age-appropriate neurocognitive test and a standardised neurological follow-up. Positive and negative predictive values and receiver operating characteristic curves were calculated to evaluate the prognostic value. RESULTS:S100B showed best positive and negative predictive value, 72.7% and 90.5%, respectively, and a significant area under the curve of 0.820. NSE showed a positive and a negative predictive value of 43.8% and 81.3% and an area under the curve of 0.757. Severely abnormal aEEG and abnormal MRI significantly correlated with outcome (p = 0.024 and 0.001 respectively). CONCLUSION:S100B and NSE on day one, severely abnormal aEEG and abnormal MRI show a significant correlation and good predictive value for neurocognitive outcome.
Aim: The current study determined the neurodevelopmental outcome of extremely preterm infants at 2 years of age. Methods: All live-born infants 23-27 weeks of gestation born between 2011 and 2020 in Austria were included in a prospective registry. Neurodevelopmental outcome at 2 years of corrected age was assessed using Bayley Scales of Infant Development for both motor and cognitive scores, along with a neurological examination and an assessment of neurosensory function. Results: 2378 out of 2905 (81.9%) live-born infants survived to 2 years of corrected age. Follow-up data were available for 1488 children (62.6%). Overall, 43.0% had no, 35.0% mild and 22.0% moderate-to-severe impairment. The percentage of children with moderate-to-severe neurodevelopmental impairment decreased with increasing gestational age and was 31.4%, 30.5%, 23.3%, 19.0% and 16.5% at 23, 24, 25, 26 and 27 weeks gestational age (p < 0.001). Results did not change over the 10-year period. In multivariate analysis, neonatal complications as well as male sex were significantly associated with an increased risk of neurodevelopmental impairment. Conclusion: In this cohort study, a 22.0% rate of moderate-to-severe neurodevelopmental impairment was observed among children born extremely preterm. This national data is important for both counselling parents and guiding the allocation of health resources.
Associations between serum biomarkers S100 calcium-binding protein B (S100B) and neuron-specific enolase (NSE) in neonates with hypoxic-ischaemic encephalopathy (HIE) offer contradicting data in regard to neurocognitive outcome. The aim of our study was to provide another dataset to answer this question if S100B or NSE correlates to outcome in neonatal HIE. In addition, we investigate whether amplitude-integrated EEG (aEEG) or magnetic resonance imaging (MRI) also has predictive value. In neonates with HIE born in Vorarlberg, Austria, ( n = 34) from 2012to 2020, NSE and S100B serum levels were measured on day one. aEEG was installed at admission and MRI performed within 7 days. Surviving children ( n = 27) were categorised as good or poor outcome by using an age-appropriate neurocognitive test and a standardised neurological follow-up. Positive and negative predictive values and receiver operating characteristic curves were calculated to evaluate the prognostic value. S100B showed best positive and negative predictive value, 72.7% and 90.5%, respectively, and a significant area under the curve of 0.820. NSE showed a positive and a negative predictive value of 43.8% and 81.3% and an area under the curve of 0.757. Severely abnormal aEEG and abnormal MRI significantly correlated with outcome ( p = 0.024 and 0.001 respectively). S100B and NSE on day one, severely abnormal aEEG and abnormal MRI show a significant correlation and good predictive value for neurocognitive outcome.
Das intestinale Mikrobiom erfüllt im menschlichen Körper eine Vielzahl an Aufgaben. Veränderungen in der Besiedelung des Darms und in der Zusammensetzung des Mikrobioms beim Neugeborenen können in Verbindung mit der Ausbildung von Erkrankungen gesehen werden. Auch bei der nekrotisierenden Enterokolitis spielen die Darmmikroben eine führende Rolle. Der Zusammenhang zwischen der Ausbildung und Zusammensetzung des Darmmikrobioms bei Neu- und Frühgeborenen sowie bei Patienten und Patientinnen, die eine nekrotisierende Enterokolitis ausbilden, lässt vielversprechende Ansätze der Prävention der nekrotisierenden Enterokolitis zu. Es sollen ein Einblick in den aktuellen Stand der Forschung gegeben und die Möglichkeiten in der Prävention der nekrotisierenden Enterokolitis mithilfe Prä- und Probiotika aufgezeigt werden. Für die Literaturrecherche wurde die Datenbank PubMed herangezogen. Mithilfe der Stichwörter „((intestinal microbiome) OR (microbiota) OR (gut microbiota)) AND (infants) AND (necrotizing enterocolitis) AND ((probiotic) OR (probiotics))“ wurde nach rezenten Metaanalysen und systematischen Reviews gesucht. Die eingeschlossenen Publikationen wurden schließlich mithilfe der „Schneeballrecherche“ (Vorwärts- und Rückwärtssuche) ergänzt. In der aktuellen Literatur finden sich Studien, die den Benefit von Probiotika in Bezug auf die nekrotisierende Enterokolitis zeigen. Aufgrund der Heterogenität der einzelnen Studien ist eine Aussage über die optimale Dosis und Verabreichung von Probiotika derzeit noch Forschungsgegenstand. Die Verabreichung von mehreren Stämmen (Lactobazillen und Bifidobakterien) ist neben weiteren Maßnahmen (Art der Ernährung, verantwortungsvoller Einsatz von Antibiotika und Hygienemaßnahmen) am vielversprechendsten.
Hintergrund Jedes Jahr werden weltweit geschätzt 15 Millionen Frühgeborene( < 37 SSW) geboren, welche im Verlauf ihrer Entwicklung ein erhöhtes Risiko für ein psychomotorisches und kognitives Defizit haben. Um dem entgegenzuwirken werden Nachsorgeuntersuchungen im korrigierten Alter von 24 Monaten durchgeführt, welche dabei helfen sollen, förderungsbedürftige Kinder zu identifizieren und zu unterstützen.
Aim: The aim of this study was to analyze neurodevelopmental outcome of very and extremely preterm infants in Vorarlberg, Austria, accessed with neurodevelopmental testing, at the corrected age of 24 months. This article also compared these results with (inter)national data and analyzed the impact of perinatal parameters. Methods: Population-based, retrospective multicenter study with data on very and extremely preterm infants born in Vorarlberg from 2007 to 2019 assessed with Bayley Scales of Infant Development (BSID-II/Bayley-III). Results: Included were 264 infants with a mean age of 29.0 (+/- 2.1) weeks of gestational age and a mean birth weight of 1177 (+/- 328.26) g; 172 infants underwent a BSID-II, 92 a Bayley-III assessment. The psychomotor developmental index (PDI) and mental developmental index (MDI) showed mean scores of 99.6 (+/- 14.4) and 91 (+/- 20.4), respectively. Adverse outcomes (scores <70) were assessed in 4.2% for PDI and 15.5% for MDI. In the extremely preterm group (n = 79), results for mean PDI were 100.1 (+/- 16.8) and for mean MDI 88.4 (+/- 22.4). Accordingly, adverse outcomes were assessed in 5.1% for PDI and in 20.3% for MDI. In addition to bronchopulmonary dysplasia and intraventricular hemorrhage Grade 3-4, head circumference at birth and patent ductus arteriosus were also identified as risk factors for poor outcome. Conclusion: This study showed a remarkably good neurodevelopmental outcome in preterm infants with low rates of adverse outcome, similar to (inter)national reports, especially in the group of extremely preterm infants. Research is needed to explore the role of social factors and infants' environment, especially cognitive outcome and language skills.
Hintergrund Die therapeutische Hypothermie stellt die einzige neuro-protektive Therapie bei moderater bis schwerer hypoxisch-ischämischer Enzephalopathie von Neugeborenen dar. Ein Monitoring mit Serumbiomarkern soll als Ergänzung zur bisherigen Diagnostik, bestehend aus klinischen Untersuchungen, laborchemischen Parametern, elektrophysiologischen Untersuchungen sowie Bildgebungsverfahren, frühzeitige Interventionen ermöglichen und Informationen über den Therapieerfolg und die Prognose liefern.