Efficacy of a new technique - INtubate-RECruit-SURfactant-Extubate - "IN-REC-SUR-E" - in preterm neonates with respiratory distress syndrome: Study protocol for a randomized controlled trial

Background: Although beneficial in clinical practice, the INtubate-SURfactant-Extubate (IN-SUR-E) method is not successful in all preterm neonates with respiratory distress syndrome, with a reported failure rate ranging from 19 to 69 %. One of the possible mechanisms responsible for the unsuccessful IN-SUR-E method, requiring subsequent re-intubation and mechanical ventilation, is the inability of the preterm lung to achieve and maintain an "optimal" functional residual capacity. The importance of lung recruitment before surfactant administration has been demonstrated in animal studies showing that recruitment leads to a more homogeneous surfactant distribution within the lungs. Therefore, the aim of this study is to compare the application of a recruitment maneuver using the high-frequency oscillatory ventilation (HFOV) modality just before the surfactant administration followed by rapid extubation (INtubate-RECruit-SURfactant-Extubate: IN-REC-SUR-E) with IN-SUR-E alone in spontaneously breathing preterm infants requiring nasal continuous positive airway pressure (nCPAP) as initial respiratory support and reaching pre-defined CPAP failure criteria. Methods/design: In this study, 206 spontaneously breathing infants born at 24+0-27+6 weeks' gestation and failing nCPAP during the first 24 h of life, will be randomized to receive an HFOV recruitment maneuver (IN-REC-SUR-E) or no recruitment maneuver (IN-SUR-E) just prior to surfactant administration followed by prompt extubation. The primary outcome is the need for mechanical ventilation within the first 3 days of life. Infants in both groups will be considered to have reached the primary outcome when they are not extubated within 30 min after surfactant administration or when they meet the nCPAP failure criteria after extubation. Discussion: From all available data no definitive evidence exists about a positive effect of recruitment before surfactant instillation, but a rationale exists for testing the following hypothesis: a lung recruitment maneuver performed with a step-by-step Continuous Distending Pressure increase during High-Frequency Oscillatory Ventilation (and not with a sustained inflation) could have a positive effects in terms of improved surfactant distribution and consequent its major efficacy in preterm newborns with respiratory distress syndrome. This represents our challenge. Trial registration: ClinicalTrials.gov identifier: NCT02482766. Registered on 1 June 2015

Weaning from mechanical ventilation

Mechanical ventilation is often required by very preterm infants with respiratory failure, even if invasive respiratory support is related to lung injury and adverse neurologic outcomes. The exposure to mechanical ventilation should be therefore limited. Optimal extubation however remains challenging, as approximately 30% of intubated preterm infants fails attempted extubation due to poor respiratory drive, atelectasis, residual pulmonary function abnormalities or intercurrent illness. This review outlines the advantages of different weaning strategies that should be considered by neonatologists for current use to reduce unsuccessful extubation

Neonatal resuscitation practices in Italy: a survey of the Italian Society of Neonatology (SIN) and the Union of European Neonatal and Perinatal Societies (UENPS)

Background Providing appropriate care at birth remains a crucial strategy for reducing neonatal mortality and morbidity. We aimed to evaluate the consistency of practice and the adherence to the international guidelines on neonatal resuscitation in level-I and level-II Italian birth hospitals. Methods This was a cross-sectional electronic survey. A 91-item questionnaire focusing on current delivery room practices in neonatal resuscitation was sent to the directors of 418 Italian neonatal facilities. Results The response rate was 61.7% (258/418), comprising 95.6% (110/115) from level-II and 49.0% (148/303) from level-I centres. In 2018, approximately 300,000 births occurred at the participating hospitals, with a median of 1664 births/centre in level-II and 737 births/centre in level-I hospitals. Participating level-II hospitals provided nasal-CPAP and/or high-flow nasal cannulae (100%), mechanical ventilation (99.1%), HFOV (71.0%), inhaled nitric oxide (80.0%), therapeutic hypothermia (76.4%), and extracorporeal membrane oxygenation ECMO (8.2%). Nasal-CPAP and/or high-flow nasal cannulae and mechanical ventilation were available in 77.7 and 21.6% of the level-I centres, respectively. Multidisciplinary antenatal counselling was routinely offered to parents at 90.0% (90) of level-II hospitals, and 57.4% (85) of level-I hospitals (p < 0.001). Laryngeal masks were available in more than 90% of participating hospitals while an end-tidal CO2 detector was available in only 20%. Significant differences between level-II and level-I centres were found in the composition of resuscitation teams for high-risk deliveries, team briefings before resuscitation, providers qualified with full resuscitation skills, self-confidence, and use of sodium bicarbonate. Conclusions This survey provides insight into neonatal resuscitation practices in a large sample of Italian hospitals. Overall, adherence to international guidelines on neonatal resuscitation was high, but differences in practice between the participating centres and the guidelines exist. Clinicians and stakeholders should consider this information when allocating resources and planning perinatal programs in Italy

Editorial: Visibility matters – women in neonatology

We are delighted to present the inaugural Frontiers in Pediatrics Women in Neonatology series. Gender inequity in health and medical research has been perpetuated by longstanding biases (including unconscious bias), stereotypes and structural barriers to the recruitment, retention, career progression and recognition of women’s achievements. While many structural changes are required to address these factors towards achieving equity, active allyship and visibility is also important to support and encourage the next generation of women and girls to pursue research careers. This article collection includes 5 original research papers, 2 brief research reports and 1 review article demonstrating a diversity of neonatology-related research led by women. Depicolzuane et al. reviewed and presented a summary of animal and translational studies, and clinical observations on the role of lung surfactant protein A in lung function and importantly in lung protection from both infectious and non-infectious agents. Surfactant protein A has a unique role in the lung through its interactions with lung macrophages where it impacts the activity of alveolar macrophages in response to injurious agents or stimuli. Interestingly, surfactant protein A also has a role in control of the in utero environment

Flow-synchronized nasal intermittent positive pressure ventilation in the preterm infant: development of a project

This manuscript describes the experience of our team in developing a flow-triggered nasal respiratory support for the neonate and its related clinical applications. Although mechanical ventilation (MV) via an endotracheal tube has undoubtedly led to improvement in neonatal survival in the last 40 years, the prolonged use of this technique may predispose the infant to the development of many possible complications, first of all, bronchopulmonary dysplasia (BPD). Avoiding mechanical ventilation is thought to be a critical goal, and different modes of non invasive respiratory support may reduce the intubation rate: nasal continuous positive airway pressure (NCPAP), nasal intermittent positive pressure ventilation (NIPPV) and its more advantageous form, synchronized nasal intermittent positive pressure ventilation (SNIPPV). SNIPPV was initially performed by a capsule placed on the baby’s abdomen. To overcome the disadvantages of the abdominal capsule, our team decided to create a flow-sensor that could be interposed between the nasal prongs and the Y piece. Firstly we developed a hot-wire flow-sensor to trigger the ventilator and we showed that flow-SNIPPV can support the inspiratory effort in the post-extubation period more effectively than NCPAP. But, although accurate, the proper functioning of the hot-wire flow-sensor was easily compromised by secretions or moisture, and therefore we started to use as flow-sensor a simpler differential pressure transducer. In a following trial using the new device, we were able to demonstrate that flow-SNIPPV was more effective than conventional NCPAP in decreasing extubation failure in preterm infants who had been ventilated for respiratory distress syndrome (RDS). More recently we used flow-SNIPPV as the primary mode of ventilation, after surfactant replacement, reducing MV need and favorably affecting short-term morbidities of treated premature infants. We also successfully applied SNIPPV to treat apnea of prematurity (AOP). Finally, we developed a new shaped flow-sensor, which is smaller and lighter of the previous one and its reliability was tested using a simulated neonatal model.   Proceedings of the 9th International Workshop on Neonatology · Cagliari (Italy) · October 23rd-26th, 2013 · Learned lessons, changing practice and cutting-edge researc

Neonatal respiratory support strategies for the management of extremely low gestational age infants: an Italian survey

Abstract Background We aimed to survey Delivery Room and Neonatal Intensive Care Unit (NICU) respiratory strategies dedicated to the extremely low gestational age newborn (ELGAN – GA < 28 wks) in Italy. Methods A questionnaire was sent to 113 Italian level III centres. A lead physician and a nurse with expertise in mechanical ventilation (MV) were identified in each unit to answer. Information about those aspects of ventilatory support considered by center’s staff as needing improvement was also collected. Results A 100% response rate was obtained. In the Delivery Room, sustained lung inflation was performed in 74.8% of centres, and 89.2% used NCPAP. For ELGANs who need invasive MV, conventional MV was the most used strategy. Volume-targeted ventilation and High-frequency oscillatory ventilation (HFOV) were considered as primary mode in < 30% of centres. Among non-invasive strategies, NCPAP was the most utilized, followed by BiPAP, High-flow nasal cannula and nasal intermittent positive pressure ventilation. Nurses more commonly recorded in the nursing charts the ventilator’s setting parameters rather than measured ones. HFOV and non-invasive ventilation were the most quoted aspects of neonatal ventilation felt as to be improved. Conclusion The routine respiratory support practices in Italy showed marked variations among units. Focused interventions are largely required to improve clinical practice

Delivery room management of extremely low birth weight infants in Italy: Comparison between academic and non-academic birth centres

Objective: International Guidelines provide a standardised approach to newborn resuscitation in the DR and, in their most recent versions, recommendations dedicated to management of ELBWI were progressively increased. It is expected that introduction in clinical practice and dissemination of the most recent evidence should be more consistent in academic than in non-academic hospitals. The aim of the study was to compare adherence to the International Guidelines and consistency of practice in delivery room management of extremely low birth weight infants between academic and non-academic institutions.Methods: A questionnaire was sent to the directors of all Italian level III centres between April and August 2012.Results: There was a 92% (n = 98/107) response rate. Apart from polyethylene wrapping to optimise thermal control, perinatal management approach was comparable between academic and non-academic centres.Conclusions: There were minor differences in management of extremely low birth weight infants between Italian academic and non-academic institutions, apart from thermal management. Although there was a good, overall adherence to the International Guidelines for Neonatal Resuscitation, temperature management was not in accordance with official recommendations and every effort has to be done to improve this aspect

Sustained lung inflation in the delivery room in preterm infants at high risk of respiratory distress syndrome (SLI STUDY): study protocol for a randomized controlled trial

Some studies have suggested that the early sustained lung inflation (SLI) procedure is effective in decreasing the need for mechanical ventilation (MV) and improving respiratory outcome in preterm infants. We planned the present randomized controlled trial to confirm or refute these findings. In this study, 276 infants born at 25(+0) to 28(+6) weeks' gestation at high risk of respiratory distress syndrome (RDS) will be randomized to receive the SLI maneuver (25 cmH2O for 15 seconds) followed by nasal continuous positive airway pressure (NCPAP) or NCPAP alone in the delivery room. SLI and NCPAP will be delivered using a neonatal mask and a T-piece ventilator.The primary endpoint is the need for MV in the first 72 hours of life. The secondary endpoints include the need and duration of respiratory support (NCPAP, MV and surfactant), and the occurrence of bronchopulmonary dysplasia (BPD). Trial registration number: NCT01440868