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IntroductionThrombotic events in neonates and children represent a rare although severe occurrence in view of the associated risk of mortality and sequelae. Quality evidence is limited in this field, and registry studies provide an essential base for research. The aim of this paper is to present the new Italian Registry of Infantile Thrombosis (RITI), set it into the scene of international thrombosis and stroke registries, and provide some insight on the challenges associated with registry management.MethodsWe present the detailed structure and content of the new RITI registry, a brief overview of its main data, and a reflection on its features, pitfalls and the main challenges related to its management.ResultsThe RITI, initially started in 2007 and officially re-launched in 2017 after structural modifications, is a non-interventional retrospective and prospective registry study collecting data on neonatal and pediatric patients (0–18 years) who experienced a systemic or cerebral thrombotic event in Italy. The RITI is managed by a multidisciplinary team with expertise in pediatric thrombosis, and participation is open to all Italian physicians, on a voluntary basis. The overall aim of the registry is to acquire new evidence to better characterize the population of children with thrombotic events and improve their management and outcome. 48 Italian pediatric and intensive care units are actively involved in the RITI, including 85 medical doctors from 16 Italian regions. A total of 1,001 neonates and children affected by cerebral or systemic thrombosis have been enrolled.DiscussionThe RITI is one of the largest available European registries of neonatal and pediatric thrombosis. National registries like the RITI represent a model for the study of rare conditions based on multidisciplinary and multicenter collaboration, aimed at overcoming the limitations due to small populations of patients, and creating a network of experts for patient referral and continuous education. Moreover, registry studies have a pivotal role in the research on pediatric thrombosis, due to the limited feasibility of high-quality studies. In our experience, the main critical stages, pitfalls and challenges in registry management include adequate registry designing, diffusion, data completeness and quality control.

Importance: A multicenter randomized clinical trial (RCT) showed a lung recruitment maneuver using high-frequency oscillatory ventilation just before surfactant administration (ie, intubate-recruit-surfactant-extubate [IN-REC-SUR-E]) improved the efficacy of treatment compared with the standard intubate-surfactant-extubate (IN-SUR-E) technique without increasing the risk of adverse neonatal outcomes., Objective: To examine follow-up outcomes at corrected postnatal age (cPNA) 2 years of preterm infants previously enrolled in an RCT and treated with IN-REC-SUR-E or IN-SUR-E in 35 tertiary neonatal intensive care units., Design, Setting, and Participants: This was a follow-up study of infants recruited into the primary RCT from 2015 to 2018 at 35 tertiary neonatal intensive care units (NICUs) in Italy. Follow-up examinations included neurodevelopmental, growth, and respiratory outcomes of these children at cPNA 2 years. Participants included spontaneously breathing extremely preterm neonates (24 0/7 to 27 6/7 weeks' gestation) reaching failure criteria for continuous positive airway pressure within the first 24 hours of life. Data were analyzed from April 2023 to January 2024., Intervention: Infants were randomly assigned (1:1) to IN-REC-SUR-E or IN-SUR-E and then followed up., Main Outcomes and Measures: The primary outcome was the occurrence of death after discharge or major disability at cPNA 2 years. Secondary outcomes were neurodevelopmental outcomes (major disability, cerebral palsy, cognitive impairment, visual deficit, or auditory deficit), anthropometric measurements (weight, length, and head circumference), and recurrent respiratory infections and hospitalizations because of respiratory causes at 2y cPNA., Results: A total of 137 extremely preterm infants (median [IQR] gestational age, 26.5 [25.3-27.5] weeks and 75 [54.7%] female), initially enrolled in the original RCT, were followed up at cPNA 2 years, including 64 infants in the IN-SUR-E group and 73 infants in the IN-REC-SUR-E group. There were no significant differences in the occurrence of death after discharge or major disability at cPNA 2 years (IN-SUR-E: 13 children [20.3%] vs IN-REC-SUR-E: 10 children [13.7%]; P = .36). There were no significant differences in incidence of disability, cerebral palsy, or cognitive impairment in the IN-REC-SUR-E group compared with the IN-SUR-E group. There were no significant differences in anthropometric measurements (weight, length, and head circumference) between groups. There were no significant differences in the incidence of recurrent respiratory infections or in hospitalizations because of respiratory causes between groups., Conclusions and Relevance: In this RCT of lung recruitment before surfactant vs standard care there were no significant differences between the 2 groups in death, neurodevelopmental outcomes, anthropometric measurements, or recurrent respiratory infections at the 2-year follow-up. These findings can aid clinicians in decision-making for the best strategy to administer surfactant, considering long-term outcomes.

Background: Preterm birth is a risk factor for a child's neurological development. Preterm children have unusual neurodevelopmental profiles with executive, visual-motor functions, fine and gross motor skills, language and behavior that affect learning. In this study, we analyzed the neurodevelopmental outcomes of a cohort of very low birth weight infants admitted to the Treviso Neonatal Intensive Care Unit (NICU) between 2014 and 2016 and followed up to preschool childhood., Method: This is a prospective cohort study. Infants were followed at birth and after NICU discharge at two- and four-year follow-ups. The two-year assessment was conducted with Bayley III, and at four years with the Wechsler Preschool and Primary Scale of Intelligence - III scales and Movement Assessment Battery for Children - 2., Results: The cohort consisted of 207 subjects with a mean gestational age of 28.9 weeks, and a mean birth weight of 1097.2 g. At two years of age, children without disabilities were 90 (59.6%), those with minor disabilities 47 (31.1%), and those with major disabilities 14 (9.3%); at four years, 58.4% of children without previous disabilities, presented problems with verbal tests and manual dexterity: aiming, grasping and balance at movement assessment. There was significant alteration in processing speed (p < 0.001). Furthermore, there was a strong correlation between processing speed and manual dexterity (p < 0.001) and between processing speed and aiming and grasping (p = 0.0059)., Conclusions: We found that more than half the children free of disability at two years, at four years had deficit often involving the oculo-motor coordination and processing speed. These motor profile alterations limit the expression of cognitive abilities and the achievement of expected school performance, thus resulting in behavioral disorders, typical of preterm children. Early professional follow-up could improve the expected educational outcomes., (© 2023. The Author(s).)

Sucrose is effective in reducing pain during minor procedures in neonates. We evaluated whether a second dose of sucrose was more effective than a single dose during venipuncture. We performed a randomised, double-blind, controlled trial at the NICU of Padua Hospital (August 2016-October 2017). We randomised 72 preterm infants undergoing venipuncture for routine test to a control group, which received a single standard dose of sucrose 2' before the procedure and a placebo 30″ after the venipuncture, and an experimental group in which they received two doses of 24% sucrose 2' before and 30″ after the venipuncture. No difference in pain perception was found between the groups at 30″, 60″ and 120″. In conclusion, we do not recommend a second dose of sucrose during venipuncture in prematures., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Cavicchiolo, Daverio, Battajon, Frigo and Lago.)

Background: The thermal servo-controlled systems are routinely used in neonatal intensive care units (NICUs) to accurately manage patient temperature, but their role during the immediate postnatal phase has not been previously assessed., Objective: To compare two modalities of thermal management (with and without the use of a servo-controlled system) immediately after birth., Study Design and Setting: Multicentre, unblinded, randomised trial conducted 15 Italian tertiary hospitals., Participants: Infants with estimated birth weight <1500 g and/or gestational age <30 +6 weeks., Intervention: Thermal management with or without a thermal servo-controlled system during stabilisation in the delivery room., Primary Outcome: Proportion of normothermia at NICU admission (axillary temperature 36.5°C-37.5°C)., Results: At NICU admission, normothermia was achieved in 89/225 neonates (39.6%) with the thermal servo-controlled system and 95/225 neonates (42.2%) without the thermal servo-controlled system (risk ratio 0.94, 95% CI 0.75 to 1.17). Thermal servo-controlled system was associated with increased mild hypothermia (36°C-36.4°C) (risk ratio 1.48, 95% CI 1.09 to 2.01)., Conclusions: In very low birthweight infants, thermal management with the servo-controlled system conferred no advantage in maintaining normothermia at NICU admission, while it was associated with increased mild hypothermia. Thermal management of preterm infants immediately after birth remains a challenge., Trial Registration Number: NCT03844204., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Developmental Language Disorder (DLD) is frequent in childhood and may have long-term sequelae. By employing an evidence-based approach, this scoping review aims at identifying (a) early predictors of DLD; (b) the optimal age range for the use of screening and diagnostic tools; (c) effective diagnostic tools in preschool children., Methods: We considered systematic reviews, meta-analyses, and primary observational studies with control groups on predictive, sensitivity and specificity values of screening and diagnostic tools and psycholinguistic measures for the assessment of DLD in preschool children. We identified 37 studies, consisting of 10 systematic reviews and 27 primary studies., Results: Delay in gesture production, receptive and/or expressive vocabulary, syntactic comprehension, or word combination up to 30 months emerged as early predictors of DLD, a family history of DLD appeared to be a major risk factor, and low socioeconomic status and environmental input were reported as risk factors with lower predictive power. Optimal time for screening is suggested between age 2 and 3, for diagnosis around age 4. Because of the high variability of sensitivity and specificity values, joint use of standardized and psycholinguistic measures is suggested to increase diagnostic accuracy., Conclusions: Monitoring risk situations and employing caregivers' reports, clinical assessment and multiple linguistic measures are fundamental for an early identification of DLD and timely interventions.

Aim: The aim of this paper was to study the evolution of ventriculomegaly, the treatment and the developmental problems of a group of very low birth weight infants (VLBWI) born between 1985 and 1999 who met Levene's percentiles for post-hemorrhagic ventricular dilatation (PHVD)., Methods: A retrospective hospital-based study of a cohort of 66 VLBWI who fulfilled the diagnostic criteria for PHVD was performed. Measures of neurodevelopmental outcome were evaluated by analyzing neurosensorial patterns as well as mental and behavioral adjustment up to pre-school age in 35 survivors., Results: The PHVDs initially (1985-1989) were due to a grade 4 intraventricular hemorrhage (IVH) (71.4%), and in the latter period (1995-1999) to IVH grade 2 (36.4%), grade 3 (31.8%) and grade 4 (31.8%). Acetazolamide has been used since the 90's in neonates with progressive PHVD. The 90s were characterized by an increasing incidence of tiny babies and rapidly-progressive PHVD. Taps were more frequent in the arrested dilatation group. Similarly, taps and acetazolamide were administered to newborns with persistent, slowly-progressive ventricular dilatation (PHVD > 4 weeks). The highest correlation was found for gestational age with the mental and psychomotor developmental indexes. Delayed performance and/or mental retardation were diagnosed in 71.4% of the survivors., Conclusion: Acetazolamide and lumbar puncture, associated with other risk variables (severity of IVH, PHVD evolution and associated parenchymal lesions) are harmful in terms of development, but they have a role in the short-term arrested and slowly progressive PHVD of the surviving babies, and not in the mortality incidence. Our retrospective data demonstrated that lower gestational age at birth increased the risk of lower mental and psychomotor developmental indexes.

Longitudinal follow-up of preterm neonates after discharge from Intensive Care satisfies the family's need for support and ensures an ongoing link with the hospital concerned, but must be based on a specific, sensitive and predictive screening program. We report a prospective cohort study in a tertiary neonatal intensive care unit (NICU) using the Perinatal Risk Inventory (PERI)1, at discharge. Of 87 consecutive newborn referred to the tertiary NICU at the Pediatrics Department of Padua University in 1993 (gestational age > or = 25 weeks, weight at birth < 1500 g), 65 (75%) survived: 54 cases complied with the Fitzhardinge '80 criteria and were followed up to at least 1 year (corrected age). A further 18 neonates with neonatal cerebral problems were also considered. The PERI at discharge was combined with neonatological and neuro-evolutional evaluation and examination of neuro-sensorial development indicators at the corrected ages of 0, 3, 6 and 12 months. PERI scores were: < or = 7 in 36; 8-11 in 22; > 11 in 14. The cut off point at 7 to 11 increases the sensitivity, the specificity and the predictive values of the test. At 1 year (corrected age), 6 patients (8.3%) had a diagnosis of spastic diplegia and 2 (2.7%) had spastic hemiplegia. The relative risk of cerebral paralysis was 4.5 in the neonates with IVH 4 degrees, odds ratio 6.7, and 3.6 in the 16 patients with bronchopulmonary dysplasia (BPD), odds ratio 4.7. 72 patients were selected for follow-up by the Fitzhardinge '80 criteria, whereas with the PERI (cut off point 7) only 44 neonates would have been selected. This confirms the need for new criteria in recruiting preterm neonates for longitudinal follow-up to quantify neurological risks, particularly in view of the socioeconomic impact of the problem.