Background: Parents play a crucial role in the care of infants during their stay in the neonatal intensive care unit (NICU). Recent studies have reported a decrease in parental participation due to the coronavirus disease (COVID-19) pandemic, which has led to restricted access policies in hospitals. The aim of this study was to describe the barriers to good parental participation during their stay in the neonatal intensive care unit in the COVID-19 era. Methods: This was a quantitative, observational study. Results: A total of 270 parents participated in this study. Mothers’ participation in care was higher than that of fathers (p = 0.017). Parents who lived at the birth of their first child reported a better level of participation in care compared to those who lived at the birth of their second-born (p = 0.005). Parents of extremely preterm neonates reported a lower interaction with their infants than parents of term newborns (p < 0.001). Conclusions: Some disadvantaged categories reported lower scores for cultural and linguistic minorities, parents of multiple children, and fathers. The COVID-19 pandemic has made several family-centred care activities impossible, with a higher impact on those who benefited most of these facilities. This study was prospectively approved by the IRB-CRRM of the University “G. d’Annunzio” Chieti-Pescara on 23 January 2024 (approval number CRRM: 2023_12_07_01).

Background: Surfactant is a well-established therapy for preterm neonates affected by respiratory distress syndrome (RDS). The goals of different methods of surfactant administration are to reduce the duration of mechanical ventilation and the severity of bronchopulmonary dysplasia (BPD); however, the optimal administration method remains unknown. This study compares the effectiveness of the INtubate-RECruit-SURfactant-Extubate (IN-REC-SUR-E) technique with the less-invasive surfactant administration (LISA) technique, in increasing BPD-free survival of preterm infants. This is an international unblinded multicenter randomized controlled study in which preterm infants will be randomized into two groups to receive IN-REC-SUR-E or LISA surfactant administration. Methods: In this study, 382 infants born at 24⁺⁰–27⁺⁶ weeks’ gestation, not intubated in the delivery room and failing nasal continuous positive airway pressure (nCPAP) or nasal intermittent positive pressure ventilation (NIPPV) during the first 24 h of life, will be randomized 1:1 to receive IN-REC-SUR-E or LISA surfactant administration. The primary outcome is a composite outcome of death or BPD at 36 weeks’ postmenstrual age. The secondary outcomes are BPD at 36 weeks’ postmenstrual age; death; pulse oximetry/fraction of inspired oxygen; severe intraventricular hemorrhage; pneumothorax; duration of respiratory support and oxygen therapy; pulmonary hemorrhage; patent ductus arteriosus undergoing treatment; percentage of infants receiving more doses of surfactant; periventricular leukomalacia, severe retinopathy of prematurity, necrotizing enterocolitis, sepsis; total in-hospital stay; systemic postnatal steroids; neurodevelopmental outcomes; and respiratory function testing at 24 months of age. Randomization will be centrally provided using both stratification and permuted blocks with random block sizes and block order. Stratification factors will include center and gestational age (24⁺⁰ to 25⁺⁶ weeks or 26⁺⁰ to 27⁺⁶ weeks). Analyses will be conducted in both intention-to-treat and per-protocol populations, utilizing a log-binomial regression model that corrects for stratification factors to estimate the adjusted relative risk (RR). Discussion: This trial is designed to provide robust data on the best method of surfactant administration in spontaneously breathing preterm infants born at 24⁺⁰–27⁺⁶ weeks’ gestation affected by RDS and failing nCPAP or NIPPV during the first 24 h of life, comparing IN-REC-SUR-E to LISA technique, in increasing BPD-free survival at 36 weeks’ postmenstrual age of life. Trial registration: ClinicalTrials.gov NCT05711966. Registered on February 3, 2023.

Background: During the stay in the neonatal intensive care unit, parents play a crucial role in the care of their infants. Recent studies reported a decrease in parental participation due to Coronavirus Disease (COVID-19) pandemic that determined restricted access policies in hospitals. The aim of this study is to describe the barriers to a good parents’ participation during the stay in the neonatal intensive care unit in the COVID-19 era. Methods: A quantitative observational study was carried out. Results: 270 parents participated in this study. Mothers’ participation in care seems to be higher as compared to fathers (p = 0.017). Parents who lived the birth of their first child reported a better level of participation in care when compared to those who lived the birth of their second born (p = 0.005). Parents of extremely preterm neonates reported a lower interaction with their infant if compared to parents of term newborns (p < 0.001). Conclusions: Some more disadvantaged categories have reported lower scores: cultural and linguistic minorities, parents of multiple children and fathers. COVID-19 pandemic made several Family Centred Care activities not possible with a higher impact on those who benefited the most of these facilities. This study was prospectively registered by the IRB-CRRM of the University “G. d’Annunzio” Chieti-Pescara on the 23/01/2024 with registration number CRRM;2023_12_07_01.

Background: Surfactant is a well-established therapy for preterm neonates affected by respiratory distress syndrome (RDS). Goals of different methods of surfactant administration are to reduce duration of mechanical ventilation and the severity of bronchopulmonary dysplasia (BPD), however the optimal administration method remains unknown. This study compares the effectiveness of the INtubate-RECruit-SURfactant-Extubate (IN-REC-SUR-E) technique with the less invasive surfactant administration (LISA) technique, in increasing BPD-free survival of preterm infants. This is an international unblinded multicenter randomized controlled study in which preterm infants will be randomized into two groups to receive IN-REC-SUR-E or LISA surfactant administration. Methods: In this study 382 infants born at 24⁺⁰-27⁺⁶ weeks’ gestation, not intubated in the delivery room and failing nasal continuous positive airway pressure (nCPAP) or nasal intermittent positive pressure ventilation (NIPPV) during the first 24 h of life, will be randomized 1:1 to receive IN-REC-SUR-E or LISA surfactant administration. The primary outcome is a composite outcome of death or BPD at 36 weeks’ postmenstrual age. Secondary outcomes are: BPD at 36 weeks’ postmenstrual age; death; pulse oximetry/fraction of inspired oxygen; severe intraventricular haemorrhage; pneumothorax; duration of respiratory support and oxygen therapy; pulmonary hemorrhage; patent ductus arteriosus undergoing treatment; percentage of infants receiving more doses of surfactant; periventricular leukomalacia, severe retinopathy of prematurity, necrotizing enterocolitis, sepsis; total in-hospital stay; systemic postnatal steroids; neurodevelopmental outcomes and respiratory function testing at 24 months of age. Randomization will be centrally provided using both stratification and permuted blocks with random block sizes and block order. Stratification factors will include centre and gestational age (24⁺⁰ to 25⁺⁶ weeks or 26⁺⁰ to 27⁺⁶ weeks). Analyses will be conducted in both intention-to-treat and per-protocol populations, utilizing a log-binomial regression model that corrects for stratification factors to estimate the adjusted relative risk (RR). Discussion: This trial is designed to provide robust data on the best method of surfactant administration in spontaneously breathing preterm infants born at 24⁺⁰-27⁺⁶ weeks' gestation affected by RDS and failing nCPAP or NIPPV during the first 24 hours of life, comparing IN-REC-SUR-E to LISA technique, in increasing BPD-free survival at 36 weeks' postmenstrual age of life. Trial registration: ClinicalTrials.gov identifier NCT05711966

Respiratory syncytial virus (RSV) remains a leading cause of lower respiratory tract infection (LRTI) and hospitalization in early infancy. Following the introduction of universal nirsevimab prophylaxis in Italy during the 2024–2025 RSV season, we evaluated its real-world effectiveness against RSV-associated hospitalization and severe clinical outcomes within a test-negative design framework. We conducted a multicenter retrospective test-negative study across 88 Italian neonatal centers, including infants hospitalized for LRTI from 1 September 2024 to 30 April 2025. Clinical data were collected from hospital records using a standardized electronic questionnaire. RSV-positive hospitalized infants were considered cases, and RSV-negative hospitalized infants served as controls. Secondary outcomes included respiratory support and Neonatal Intensive Care Unit (NICU) admission. Effectiveness was estimated using multivariable logistic regression and targeted maximum likelihood estimation. Overall, 737 infants were included, of whom 306 (41.52%) had previously received nirsevimab. RSV infection was identified in 398 infants (54.00%), including 104/306 (33.99%) nirsevimab-immunized and 294/431 (68.21%) non-immunized infants (p < 0.001). Immunized infants also required respiratory support less frequently (55.23% vs. 70.07%; p < 0.001), with lower use of high-flow oxygen therapy (40.85% vs. 48.96%; p = 0.036) and Continuous Positive Airway Pressure (CPAP) (18.95% vs. 33.87%; p < 0.001). Within the test-negative design framework, adjusted effectiveness against RSV-associated hospitalization was estimated at 78.3%. Among hospitalized infants, previous nirsevimab immunization was additionally associated with adjusted relative reductions in the odds of respiratory support and NICU admission of 80.2% and 64.3%, respectively. In conclusion, among infants hospitalized for LRTI in routine Italian clinical practice, previous nirsevimab immunization was associated with lower odds of RSV positivity and a reduced need for respiratory support. Although these findings provide further evidence of the real-world effectiveness of nirsevimab against severe RSV disease, further studies are needed to provide direct estimates of hospitalization incidence in immunized and non-immunized source populations.