BACKGROUND:Blood component safety measures implemented by Blood Establishments (BE) specifically for neonates are frequently precautionary rather than evidence based. We conducted a European survey on specifications for neonatal red blood cells, platelet, and plasma transfusions. METHODS:The survey was sent to transfusion experts in BEs in 38 European countries between May 2023 and January 2024. We received responses from 20/38 countries. RESULTS:Many BEs provide neonatal components with additional safety features not routinely applied for adults, and we found evidence of significant variation in practice. 12/19 BEs used a shorter shelf life for split units compared to adult components. For neonatal exchange, 12/19 used saline-adenine-glucose-mannitol (SAGM) replaced with FFP prior to issue. Three BEs performed additional donor or component testing for neonatal units, including screening for lead concentrations (1/20). CONCLUSION:We identified three questions for which we conducted a critical literature review, around use of short-shelf life of red cells, use of additive solutions, and significance of lead concentrations for neonatal components. Although there were relevant articles addressing these questions, we found a lack of definitive evidence for much precautionary practice, and a need for wider study of the impact of lead in neonatal transfusions to inform future strategies.
Transcatheter closure is becoming the standard of care for definitive closure of patent ductus arteriosus (PDA) in premature infants. To avoid risks associated with the transportation of a fragile neonate, the intervention can be performed as a bedside procedure within the neonatal intensive care unit, even in extremely low birth weight (ELBW) infants. Limited evidence-based guidelines are available for transcatheter PDA closure in premature infants in general and for bedside PDA closure specifically. This framework represents an expert consensus regarding bedside PDA closure in ELBW infants and guidance for procedural implementation. Recommendations for patient eligibility, pre-procedural planning, staff requirements, procedural aspects, imaging and follow-up and a stepwise implementation plan for a bedside PDA closure program are presented. IMPACT: Extremely low birth weight (ELBW) infants with a patent ductus arteriosus (PDA) may be considered for transcatheter PDA closure. An expert consensus is provided on bedside transcatheter PDA closure performed within the neonatology intensive care unit, thereby mitigating the risks associated with transportation of these highly vulnerable infants outside of the neonatology intensive care unit. Guidance is provided regarding procedural aspects, including staff requirements, planning, setting, and imaging, and implementation of a bedside transcatheter PDA closure program.
Routine measurement of gastric residual volumes involves regularly aspirating the entire stomach contents to assess the volume and colour of the aspirate to inform feeding. This is an established practice in many United Kingdom and Australian neonatal units for preterm infants receiving gastric tube feeds. The rationale is to assess feed tolerance and to predict and potentially prevent necrotising enterocolitis, a serious gut condition. Routine measurement of gastric residual volumes may also be associated with adverse outcomes and harm, including delayed achievement of full enteral feeds and longer neonatal unit stay. Evidence to support the routine measurement of gastric residuals is poor, and previous small trials have not been generalisable to UK or Australian neonatal care. The aim of the neoGASTRIC trial is to test whether avoiding routine measurement of gastric residual volumes in preterm infants reduces the time taken for an infant to reach full enteral feeds without increasing necrotising enterocolitis. neoGASTRIC is an individually randomised controlled trial in neonatal units in the UK and Australia. A target of 7040 infants born before 34 weeks’ gestation will be randomly allocated, prior to receiving 24 h of enteral feeds > 15 ml/kg/day, on a 1:1 basis to have no routine gastric residual volumes measured, or to have gastric residual volumes measured routinely. Opt-out consent will be used with parent and staff views explored as part of an embedded process evaluation. The primary superiority outcome is time to reach full milk feeds ≥ 145 ml/kg/day for three consecutive days. Bell’s stage 2 or 3 necrotising enterocolitis following blinded adjudication will be the key secondary, non-inferiority safety outcome. Other neonatal core outcomes and health care resource use and costs prior to discharge will be evaluated. neoGASTRIC will address a research priority that affects more than 20,000 preterm infants in the United Kingdom and Australia annually. Even modest improvements in clinical outcomes and resource use could result in large clinical benefits and savings at a population level. ISRCTN 16710849. Prospectively registered on 8 February 2023.
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.
Every year, new evidence emerges about how best to care for tiny babies with respiratory distress. We report the seventh version of "European Guidelines for the Management of RDS" by a panel of European neonatologists and an expert perinatal obstetrician based on available literature up to mid-2025. Optimising outcome involves close collaboration with obstetricians to predict risk of preterm delivery, consideration of transfer to perinatal centres, and perinatal optimisation including antenatal steroids. Delivery room protocols should include maintenance of normal body temperature while aiming to promote spontaneous breathing before clamping the umbilical cord, using non-invasive respiratory support (NRS) where possible, and considering early use of surfactant delivered by a thin catheter in an attempt to avoid intubation. Ongoing NRS and judicious use of surfactant using techniques that avoid intubation will help improve outcomes. If mechanical ventilation is needed, lung protective strategies should be employed and ventilation continued for the shortest time possible to reduce risk of bronchopulmonary dysplasia. Protocols for general supportive care are also reviewed, with an emphasis on good nutritional care, cardiovascular support and judicious use of antibiotics.
It is paramount to optimize prevention and therapy for severe neonatal infections, particularly in high-risk infants. This perspective highlights the lack of guidelines for parenteral nutrition (PN) during suspected or confirmed infections in vulnerable newborns, especially those born preterm. Drawing on insights from immunometabolism and translational preclinical models, we argue that nutritional support during infection should not only meet energy demands but also actively shape immunity by modulating inflammation, organ injury, and clinical outcome. Conventional glucose-rich PN may fuel excessive glycolysis-driven immune activation and harmful hyperinflammation. In contrast, alternative macronutrient strategies, including partial replacement of glucose with galactose, glucogenic amino acids, or ketone bodies, may redirect host metabolism toward balanced immune responses, reduced tissue damage, and improved survival. We propose that neonatal nutrition during infection should be viewed as a modifiable therapeutic intervention and call for clinical trials to develop targeted PN protocols for vulnerable newborns at risk of infection.
OBJECTIVE:To investigate respiratory practices to prevent or treat evolving bronchopulmonary dysplasia in neonatal intensive care units (NICUs) across Europe. STUDY DESIGN:Between March and July 2024, a web-based survey was sent to European NICUs caring for infants born preterm with gestational age <28 weeks. RESULTS:We received replies from 447 of 721 (62%) NICUs across 24 European countries. Almost 16% of NICUs routinely intubate at birth, especially if the gestational age is <24 weeks. During transition most NICUs use continuous positive airway pressure ≥5 cmH2O and start with an FiO2 0.3. Volume-targeted ventilation is the primary ventilation mode in 60% of the NICUs. Permissive hypercapnia is a common practice. Higher SpO2 target limits have been adopted, although alarm settings vary across NICUs. Caffeine is routinely started (96%). Surfactant is used in all NICUs, mostly rescue (74%) via less invasive administration (81%). Prophylactic inhaled nitric oxide is not used. Treatment of patent ductus arteriosus varies; half of NICUs pharmacologically treat patent ductus arteriosus early, based on echocardiographic findings. Ureaplasma screening is done in 22% of NICUs. Most (97%) NICUs use postnatal corticosteroids, with dexamethasone being the preferred drug (65%) and starting 2-3 weeks after birth. Only 5% use corticosteroids prophylactically. After 2-3 weeks, diuretics are used frequently, inhaled corticosteroids/bronchodilators to a much lesser extent. CONCLUSIONS:This large survey shows considerable practice variation in preventing and treating evolving bronchopulmonary dysplasia across Europe, especially for interventions with limited evidence.
OBJECTIVE:To examine international perspectives on the necessity of guidelines for the care of extremely preterm infants (EPIs), what forms such guidance should take, and the extent of practice variation neonatologists find acceptable. STUDY DESIGN:Anonymous, online, cross-sectional international survey among neonatologists, exploring current and preferred guidelines and hypothetical scenarios testing acceptance of practice variation in EPI decision-making. RESULTS:We analyzed 127 responses from 47 countries. Most respondents (55%) preferred a guideline using gestational age (GA) alongside other prognostic factors; 13% preferred no guideline. In scenarios involving borderline viability, variation was accepted when based on parental wishes, cultural norms, or resource constraints, but not when reflecting hospitals or individual differences. Views on directive counseling were divided. CONCLUSIONS:Neonatologists support flexible, structured guidelines that consider more than GA alone. Variation is acceptable when reflecting parental values, cultural norms, or resource constraints but not when driven by individual or institutional preferences.
Background:Extremely preterm infants often develop anemia of prematurity, partly caused by blood losses for laboratory diagnostic tests during their stay in the neonatal intensive care unit (NICU). However, international quantitative data on diagnostic blood loss in extremely preterm infants are limited. Methods:We performed an international, prospective, observational study across 64 NICUs across 22 European countries (ISRCTN17267090) to describe diagnostic blood losses during the first 28 days after birth in extremely preterm infants born below 28 weeks. Data collected between September 1st, 2022 and August 31st, 2023 (6-weeks per center). Findings:We included 320 extremely preterm infants (46% female; median gestational age at birth 26 + 1 weeks; median birthweight 800 g). Median estimated cumulative diagnostic blood loss at day 28 in infants born at 24, 25, 26, 27 weeks' gestation was 49.6%, 25.9%, 19.7%, 11.5% of calculated initial blood volume (assuming 70 mL/kg birthweight), respectively. Median number of laboratory tests ranged from 6.5 to 25 per center after birth (postnatal day 1-2), and median associated diagnostic blood loss on day 1 and 2 combined ranged from 1.6 to 26.7 mL/kg. There was considerable variation between centers in minimum blood volumes required for laboratory testing. Infants admitted to centers with small-volume analyzers experienced half the cumulative diagnostic blood loss by day 28 (8.2 mL/kg), compared to those admitted to centers with medium- and large-volume analyzers (17.3 and 19.9 mL/kg, respectively). Interpretation:In this cohort study of extremely preterm infants, we found significant diagnostic blood losses, particularly in the first week, resulting in an estimated cumulative loss of half of the initial blood volume in infants born at 24 weeks. Our findings highlight considerable variations between European centers, underlining the need to understand these differences and minimize diagnostic blood losses whenever possible in this vulnerable patient population. Funding:Sanquin, ESPR, EBA.
Infants born extremely preterm (EP; < 28 weeks of gestation) or term born infants with hypoxic-ischemic encephalopathy (HIE) have increased risk of long-term cognitive and learning deficits. Early supplementation with long chain polyunsaturated fatty acids (LCPUFAs) docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), and arachidonic acid (ARA), choline, uridine-5′-monophosphate (UMP), and cytidine-5′-monophosphate (CMP), zinc, iodine, and vitamin B12 may improve cognitive and language outcomes in these populations. This multicentre, blinded, stratified, randomised controlled trial, including an economic evaluation, will investigate the impact of nutritional supplementation on cognitive development in infants born EP or term born infants with HIE. The planned sample size is 1010 (538 EP, and 472 HIE) infants from up to 40 National Health Service neonatal units in the UK. The trial patient populations are infants born EP (preterm stratum) and term infants (born at or more than 35 weeks of gestation) with HIE who received therapeutic hypothermia (HIE stratum). Patient strata were chosen to include infants at high risk of adverse neurodevelopmental outcomes by virtue of EP birth, or HIE requiring therapeutic hypothermia. Infants are randomly assigned, in a 1:1 allocation ratio, to receive either the active supplement or a matched control, in addition to standard care. Families, clinical teams, investigators, and Clinical Trials Unit staff are blinded to allocation. Only the Senior Trials Programmer and Trial Statisticians have access to allocation information. The active supplement is a nutrient powder formulated to be mixed with breast milk, infant formula, or food, containing LCPUFAs (including DHA, EPA, and ARA), choline, UMP, CMP, zinc, iodine, and vitamin B12. Supplementation commences once infants achieve full milk feeds and continues until 12 months post-estimated date of delivery (EDD), with a daily dosage of 1 g per kilogram of body weight. The primary outcome is the Parent Report of Children’s Abilities-Revised non-verbal cognitive scale at 24 months post-EDD. EP and HIE patient population comparisons have been appropriately powered and will be analysed separately. Findings from the DOLFIN trial will inform international neonatal and infant nutritional and feeding policy and practice. Learnings from the trial will inform the design and delivery of future neonatal nutritional intervention trials. ISRCTN62323236. Registered 16 May 2022, https://www.isrctn.com/ISRCTN62323236 .
Introduction: Taking care of critically ill newborn infants is challenging, even more so in the current era of greater use of non-invasive support, leaving limited exposure to learn critical skills. Supporting a growing workforce of neonatologists requires training of doctors with formal curriculums and assessment of skills ensuring delivery of high-quality care. Our aim was to gain an understanding of neonatal trainee experiences regarding current neonatal training across Union of European Medical Specialists (UEMS) member countries. The main focus of this survey was on pulmonology-related skills and decision-making. METHODS:A structure online survey was sent via the European Society for Paediatric Research (ESPR) newsletter and targeted national neonatology societies from 35 full and associate member countries of the UEMS. Doctors currently in neonatal subspecialty training or having finished training within the last 3 years were eligible. The survey took place between December 2023 and June 2024. All answers were anonymous. RESULTS:One hundred and eight individual responses from 24 countries were received. Trainees were confident in endotracheal intubation and postnatal surfactant administration. Current year of neonatal training was the most strongly associated factor with reported confidence in training requirements and procedures, as opposed to having a formal curriculum. Adequate face to face supervision also affected confidence in decision-making. DISCUSSION:There currently is no "unified" pathway for training, curricula and formal assessments across member countries of the UEMS. Future developments include provision of simulation-based training approaches and collaborative mentorship opportunities in caring for complex respiratory diseases affecting newborns. .
AIM:Surfactant can be administered by an endotracheal tube or by a catheter through the vocal cords, but both techniques need laryngoscopy skills and can be associated with complications. Supraglottic airway devices have also been used for surfactant administration, and we conducted an international survey to understand how much this is done in current practice. METHODS:This online survey was conducted from September 2023 to June 2024. Questions broadly addressed unit structure, practices around surfactant, and the role of supraglottic airway device in their unit. RESULTS:There were a total of 75 responses, 73% from the United Kingdom. Most of the responses were from intensive care (55%). Fifty-three units reported the use of a supraglottic airway device only in cases of unsuccessful intubation. Only 12 units report the use of a supraglottic airway device for surfactant administration. Twenty-two units reported that they are likely to use this device in the near future, and five of the special care units reported that this technique would be useful for units with limited intubation skills. CONCLUSION:There is limited uptake of using supraglottic airway device for surfactant administration. Lack of training, guidelines, and evidence are the most common reasons limiting this practice.
The European Society for Paediatric Research (ESPR) first developed recommendations for a Neonatology specific European training curriculum in 1998, with updates in 2007 and 2021. The aim of these recommendations was to define a common, European standard of training for national educational programmes for Neonatologists. Following the Union of European Medical Specialists’ (UEMS) framework of European Training Requirements (ETR), and similar to the American Board of Pediatrics (ABP) recommendations, graduates of training programmes conforming to the ETR will be eligible throughout Europe for recognition of equality of training, and with that should be enabled to freedom-of-movement. This concept also accounts for neonatal specialists. We therefore present the pan-European work on the ETR Neonatology in its third iteration (ETR III), summarising the basic requirements for contemporary training programmes, trainers, and training centres in neonatology. We highlight the European School of Neonatology (ESN) as a comprehensive online educational platform which provides the theoretical and practical background to satisfy the ETR-III. Lastly, we introduce the European Board of Neonatal & Child Health Research (EBNCHR) as a committee dedicated to gaining acceptance for the concept of harmonising education and training in Neonatology and recognising Neonatology as a Paediatric subspecialty in every European Union member state.
ObjectiveDespite lack of evidence supporting efficacy, prophylactic fresh frozen plasma and Octaplas transfusions may be administered to very preterm infants to reduce bleeding risk. International variation in plasma transfusion practices in neonatal intensive care units (NICUs) is poorly understood, therefore, we aimed to describe neonatal plasma transfusion practice in Europe.DesignProspective observational study.Setting64 NICUs in 22 European countries, with a 6-week study period per centre between September 2022 and August 2023.PatientsPreterm infants born below 32 weeks of gestational age.InterventionsAdmission to the NICU.Main outcome measuresPlasma transfusion prevalence, cumulative incidence, indications, transfusion volumes and infusion rates and adverse effects.ResultsA total of 92 of 1143 infants included (8.0%) received plasma during the study period, collectively receiving 177 transfusions. Overall prevalence was 0.3 plasma transfusion days per 100 admission days, and rates varied substantially across Europe. By day 28 of life, 13.5% (95% CI 10.0% to 16.9%) of infants received at least one plasma transfusion, accounted for competing risks of death or discharge. Transfusions were given for a broad range of indications, including active bleeding (29.4%), abnormal coagulation screen results (23.7%) and volume replacement/hypotension (21.5%). Transfusion volumes and infusion rates varied significantly; the most common volume was 15 mL/kg (range: 5–30 mL/kg) and the most common duration was 2 hours (range: 30 min to 6 hours).ConclusionsWe found wide variation in plasma transfusion practices in Europe, highlighting the need for evidence to inform neonatologists in daily practice and guidelines, in particular for non-bleeding indications.Trial registration numberISRCTN17267090.