Publications by authors named "Eugenio Baraldi"

157 Publications

Thermal management with and without servo-controlled system in preterm infants immediately after birth: a multicentre, randomised controlled study.

Arch Dis Child Fetal Neonatal Ed 2021 Feb 17. Epub 2021 Feb 17.

Department of Woman and Child Health, University Hospital of Padova, Padova, Italy

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 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.
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http://dx.doi.org/10.1136/archdischild-2020-320567DOI Listing
February 2021

Intratracheal administration of mesenchymal stem cell-derived extracellular vesicles reduces lung injuries in a chronic rat model of bronchopulmonary dysplasia.

Am J Physiol Lung Cell Mol Physiol 2021 Jan 27. Epub 2021 Jan 27.

Department of Women's and Children's Health, University of Padova.

Early therapeutic effect of intratracheally (IT)-administered extracellular vesicles secreted by mesenchymal stem cells (MSC-EVs) has been demonstrated in a rat model of bronchopulmonary dysplasia (BPD) involving hyperoxia exposure in the first 2 postnatal weeks. The aim of this study was to evaluate the protective effects of IT-administered MSC-EVs in the long term. EVs were produced from MSCs following GMP standards. At birth, rats were distributed in three groups: a) animals raised in ambient air for 6 weeks (n=10); and animals exposed to 60% hyperoxia for 2 weeks and to room air for additional 4 weeks and treated with b) IT-administered saline solution (n=10), or c) MSC-EVs (n=10) on postnatal days 3, 7, 10 and 21. Hyperoxia exposure produced significant decreases in total number of alveoli, total surface area of alveolar air spaces and proliferation index, together with increases in mean alveolar volume, mean linear intercept and fibrosis percentage; all these morphometric changes were prevented by MSC-EVs treatment. The medial thickness index for <100 µm vessels was higher for hyperoxia-exposed/sham-treated than for normoxia-exposed rats; MSC-EV treatment significantly reduced this index. There were no significant differences in interstitial/alveolar and perivascular F4/8-positive and CD86-positive macrophages. Conversely, hyperoxia exposure reduced CD163-positive macrophages both in interstitial/alveolar and perivascular populations and MSC-EV prevented these hyperoxia-induced reductions. These findings furtherly support that IT-administered EVs could be an effective approach to prevent/treat BPD, ameliorating the impaired alveolarization and pulmonary artery remodelling also in a long-term model. M2 macrophage polarization could play a role through anti-inflammatory and proliferative mechanisms.
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http://dx.doi.org/10.1152/ajplung.00148.2020DOI Listing
January 2021

Optimizing Nutritional Strategies to Prevent Necrotizing Enterocolitis and Growth Failure after Bowel Resection.

Nutrients 2021 Jan 24;13(2). Epub 2021 Jan 24.

Neonatal Intensive Care Unit, Department of Women's and Children's Health, University Hospital of Padova, 35128 Padova, Italy.

Necrotizing enterocolitis (NEC), the first cause of short bowel syndrome (SBS) in the neonate, is a serious neonatal gastrointestinal disease with an incidence of up to 11% in preterm newborns less than 1500 g of birth weight. The rate of severe NEC requiring surgery remains high, and it is estimated between 20-50%. Newborns who develop SBS need prolonged parenteral nutrition (PN), experience nutrient deficiency, failure to thrive and are at risk of neurodevelopmental impairment. Prevention of NEC is therefore mandatory to avoid SBS and its associated morbidities. In this regard, nutritional practices seem to play a key role in early life. Individualized medical and surgical therapies, as well as intestinal rehabilitation programs, are fundamental in the achievement of enteral autonomy in infants with acquired SBS. In this descriptive review, we describe the most recent evidence on nutritional practices to prevent NEC, the available tools to early detect it, the surgical management to limit bowel resection and the best nutrition to sustain growth and intestinal function.
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http://dx.doi.org/10.3390/nu13020340DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7910892PMC
January 2021

The "Hub and Spoke" (HandS) ECMO for "Resuscitating" Neonates with Respiratory Life-Threatening Conditions.

Children (Basel) 2021 Jan 5;8(1). Epub 2021 Jan 5.

Neonatal Intensive Care Unit, Department of Woman's and Child's Health, University of Padova, 35122 Padova, Italy.

Background: Extracorporeal membrane oxygenation (ECMO) implantation for neonates with severe cardiorespiratory life-threatening conditions is highly effective. However, since ECMO is a high-risk and complex therapy, this treatment is usually performed in centers with proven expertise.

Methods: A retrospective review of neonates, from January 2014 to January 2020, presenting with life-threatening conditions and treated by means of Hub and Spoke (HandS) ECMO in peripheral (spoke) hospitals. Data were retrieved from our internal ECMO registry. Protocols and checklists were revised and shared with all spoke hospitals located in North-Eastern Italy.

Results: Eleven neonates receiving maximal respiratory and cardiovascular support at a spoke hospital underwent HandS ECMO management. All but three patients were affected by life-threatening meconium aspiration syndrome (MAS). The median ECMO support duration and hospitalization were four (range 2-32) and 30 days (range 8-50), respectively. All but two patients (with congenital diaphragmatic hernia), were weaned off ECMO and discharged home. At a mean follow up of 33.7 ± 29.2 months, all survivors were alive and well, without medications, and normal somatic growth. All but one had normal neuropsychological development.

Conclusion: HandS ECMO model for neonates with life-threatening conditions is effective and successful. A specialized multidisciplinary team and close cooperation between Hub and Spoke centers are essential for success.
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http://dx.doi.org/10.3390/children8010024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7824856PMC
January 2021

The aftermath of SARS-CoV-2 in NICU: saving or checking accounts? Projected cost-effectiveness analysis.

Eur J Pediatr 2021 Jan 7. Epub 2021 Jan 7.

Department of Women's and Children's Health, University Hospital of Padova, Via N. Giustiniani, 3, 35128, Padova, Italy.

In the aftermath of the SARS-CoV-2 pandemic, we revised the cost-effectiveness of the exploited interventions in neonatal intensive care unit, to redefine future strategies for hospital management. Costs were revised with respect to the lockdown R0 or under different R0 scenarios to estimate the cost-effectiveness of the screening program adopted. Weekly nasopharyngeal swabs for parents, neonates, and personnel were the major cost during the pandemic, although they effectively reduced the number of cases in our unit.Conclusion: Parents and healthcare personnel testing appears to be an effective strategy due to the high number of contact they have within the hospital environment and outside, able to minimize the cases within our unit. What is Known: • Costs of universal COVID-19 tests for parents, neonates, and NICU personnel have not been evaluated during the COVID-19 pandemic in neonatal intensive care unit in Europe. What is New: • Weekly nasopharyngeal swabs for parents, neonates, and personnel were the major cost during the COVID-19 pandemic in NICU. • Parents and healthcare personnel testing was effective to reduce costs related to COVID-19 due to the high number of contact they have within the hospital environment and outside.
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http://dx.doi.org/10.1007/s00431-020-03884-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7790311PMC
January 2021

Trends in neonatal emergency transport in the last two decades.

Eur J Pediatr 2021 Feb 7;180(2):635-641. Epub 2021 Jan 7.

Department of Women's and Children's Health, University of Padova, Via Giustiniani, 3, 35128, Padova, Italy.

Although maternal antenatal transfer is the preferred option, some infants inevitably need urgent transport to a tertiary neonatal care facility after birth. This study aimed to investigate trends over time in patient characteristics and respiratory management in a large series of neonatal emergency transfers, in order to provide health caregivers an up-to-date profile of such patients and their therapeutic needs. Trends in patient characteristics and respiratory management were evaluated in 3337 transfers by the Eastern Veneto Neonatal Emergency Transport Service in 2000-2019. Joinpoint regression analysis was performed to evaluate trends and to estimate annual percentage changes (APCs). Proportions of preterm neonates increased (APC 2.25%), then decreased (APC - 6.04%). Transfers at birth increased (APC 2.69%), then decreased (APC - 5.76%). Proportion of neonates with cardiac and surgical diseases declined (APCs - 6.82% and - 3.32%), while proportion of neonates with neurologic diseases increased (APC 8.62%). Use of nasal-continuous-positive-airway-pressure (APC 9.72%) and high-flow-nasal-cannula (APC 58.51%) at call, and nasal-continuous-positive-airway-pressure (APC 13.87%) and nasal-intermittent-mandatory-ventilation (APC 32.46%) during transfer increased. Mechanical ventilation during transfer decreased (APC - 10.77%). Use of oxygen concentrations at 21% increased at call and during transfer (APCs 2.24% and 2.44%), while oxygen concentrations above 40% decreased at call and during transfer (APCs - 3.93% and - 5.12%).Conclusion: Our findings revealed a shift toward a more "gentle" approach and the reduced use of oxygen in respiratory management. Equipment and team expertise should meet the requirements of such changing patients and their therapeutic needs. What is Known: • Although antenatal transfer is the preferred option, some infants inevitably need urgent transport to a tertiary neonatal care facility after birth. • Trend studies investigating cohort information with appropriate statistical methods represent useful instruments to detect changes over time. What is New: • Our findings revealed marked changes in patient characteristics and respiratory management in a large series of neonatal emergency transfers during the last two decades. • Equipment and team expertise should meet the requirements of such changing patients and their therapeutic needs.
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http://dx.doi.org/10.1007/s00431-020-03908-wDOI Listing
February 2021

Lung Ultrasound to Monitor Extremely Preterm Infants and Predict BPD: Multicenter Longitudinal Cohort Study.

Am J Respir Crit Care Med 2020 Dec 22. Epub 2020 Dec 22.

South Paris University Hospitals, "A.Beclere" Medical Center, NICU, Clamart (Paris), France;

Rationale: Lung ultrasound is useful in critically ill patients with acute respiratory failure. Given its characteristics, it could be also useful in extremely preterm infants with evolving chronic respiratory failure, as we lack accurate imaging tools to monitor them.

Objectives: To verify if lung ultrasound can monitor lung aeration and function, and has good reliability to predict bronchopulmonary dysplasia in extremely preterm neonates.

Methods: Multicenter, international, prospective, longitudinal, cohort, diagnostic accuracy study consecutively enrolling inborn neonates with gestational age ≤30+6 weeks. Lung ultrasound was performed on the first, seventh, fourteenth and twenty-eighth days of life and lung ultrasound scores were calculated and correlated with simultaneous blood gases and work of breathing score. Gestational age-adjusted lung ultrasound scores were created, verified in multivariate models and subjected to ROC analyses to predict bronchopulmonary dysplasia at 36 weeks post-menstrual age.

Main Results: Mean lung ultrasound scores are different between infants developing (n=72) or not developing (n=75) BPD (p<0.001,at any time-point). Lung ultrasound scores significantly correlate with oxygenation metrics and work of breathing at any time-point (p always<0.0001). Gestational age-adjusted lung ultrasound scores significantly predict bronchopulmonary dysplasia at 7 (area under ROC curve: 0.826-0.833;p<0.0001) and 14 (area under ROC curve: 0.834-0.858;p<0.0001) days of life. Bronchopulmonary dysplasia severity and gestational age-adjusted lung ultrasound scores are significantly correlated at 7 and 14 days (p always<0.0001).

Conclusions: Lung ultrasound scores allow to monitor lung aeration and function in extremely preterm infants. Gestational age-adjusted scores significantly predict the occurrence of BPD,starting from the seventh day of life.
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http://dx.doi.org/10.1164/rccm.202008-3131OCDOI Listing
December 2020

Protecting youth from the vaping epidemic.

Pediatr Allergy Immunol 2020 11;31 Suppl 26:66-68

Department of Woman and Child's Health, University of Padova, Padova, Italy.

E-cigarettes (e-cigs) have been initially proposed as an aid to smoke cessation in adults, whereas they turned into a paradoxical preferential gateway to tobacco and nicotine initiation for adolescents naïve to tobacco. More than 25% of US school-age students is an e-cigs user with a steep rise over the past years. A marketing strategy on media and social network targeting youths, in the absence of rules to protect the pediatric users, resulted in an unprecedented trend up in tobacco consumption among adolescents and gave rise to a new generation of nicotine-addicted teenagers. Flavored e-cigs liquids and aerosols contain airway irritants and toxicants, that, in turn, produced an increase in asthma prevalence and its exacerbations among adolescents. In addition, since August 2019 an outbreak of e-cigarette, or vaping, product use-associated lung injury (EVALI) has been described. In view of this, e-cigs must no longer be considered harmless, especially in adolescents never used a tobacco product before. This is a call-for-action to establish effective rules and campaigns targeting youths aimed to limit their access to e-cigs, thereby preserving the potential benefit in quitting tobacco addiction described in adults. Behavioral and educational actions, out of the conventional primary care setting, have been described as a model for a youth-centered campaign. We call for stricter regulations on e-cigs products, with respect to their marketing to the youngest ones, along with public health and primary care interventions that could curb the spread of this "vaping" epidemic.
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http://dx.doi.org/10.1111/pai.13348DOI Listing
November 2020

Lung ultrasound is used in neonatology for diagnostics, monitoring and prognostics, but also for prevention.

Pediatr Pulmonol 2021 Feb 24;56(2):333-334. Epub 2020 Nov 24.

Neonatal Intensive Care Unit, Department of Women's and Children's Health, University of Padova, Padova, Italy.

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http://dx.doi.org/10.1002/ppul.25164DOI Listing
February 2021

Breathomics in Asthmatic Children Treated with Inhaled Corticosteroids.

Metabolites 2020 Sep 29;10(10). Epub 2020 Sep 29.

Department of Women's and Children's Health, University of Padova, 35128 Padova, Italy.

Background: "breathomics" enables indirect analysis of metabolic patterns underlying a respiratory disease. In this study, we analyze exhaled breath condensate (EBC) in asthmatic children before (T0) and after (T1) a three-week course of inhaled beclomethasone dipropionate (BDP).

Methods: we recruited steroid-naive asthmatic children for whom inhaled steroids were indicated and healthy children, evaluating asthma control, spirometry and EBC (in asthmatics at T0 and T1). A liquid-chromatography-mass-spectrometry untargeted analysis was applied to EBC and a mass spectrometry-based target analysis to urine samples.

Results: metabolomic analysis discriminated asthmatic ( = 26) from healthy children ( = 16) at T0 and T1, discovering 108 and 65 features relevant for the discrimination, respectively. Searching metabolomics databases, seven putative biomarkers with a plausible role in asthma biochemical-metabolic processes were found. After BDP treatment, asthmatic children, in the face of an improved asthma control ( < 0.001) and lung function ( = 0.01), showed neither changes in EBC metabolomic profile nor in urinary endogenous steroid profile.

Conclusions: "breathomics" can discriminate asthmatic from healthy children, with prostaglandin, fatty acid and glycerophospholipid as putative markers. The three-week course of BDP-in spite of a significant clinical improvement-was not associated with changes in EBC metabolic arrangement and urinary steroid profile.
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http://dx.doi.org/10.3390/metabo10100390DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7600137PMC
September 2020

Coronavirus infection in neonates: a systematic review.

Arch Dis Child Fetal Neonatal Ed 2020 Sep 17. Epub 2020 Sep 17.

Department of Women's and Children's Health, University of Padova, Padova, Italy.

Objective: To summarise currently reported neonatal cases of SARS-CoV-2 infection.

Methods: A search strategy was designed to retrieve all articles published from 1 December 2019 to 12 May 2020, by combining the terms 'coronavirus' OR 'covid' OR 'SARS-CoV-2') AND ('neonat*' OR 'newborn') in the following electronic databases: MEDLINE/Pubmed, Scopus, Web of Science, MedRxiv, the Cochrane Database of Systematic Review and the WHO COVID-19 database, with no language restrictions. Quality of studies was evaluated by using a specific tool for assessment of case reports and/or case series.

Results: Twenty-six observational studies (18 case reports and 8 case series) with 44 newborns with confirmed SARS-CoV-2 infection were included in the final analysis. Studies were mainly from China and Italy. Half of neonates had a documented contact with the infected mother and one out of three infected neonates was admitted from home. Median age at diagnosis was 5 days. One out of four neonates was asymptomatic, and the remaining showed mild symptoms typical of acute respiratory infections and/or gastrointestinal symptoms. The majority of neonates were left in spontaneous breathing (room air) and had good prognosis after a median duration of hospitalisation of 10 days.

Conclusions: Most neonates with SARS-CoV-2 infection were asymptomatic or presented mild symptoms, generally were left in spontaneous breathing and had a good prognosis after median 10 days of hospitalisation. Large epidemiological and clinical cohort studies, as well as the implementation of collaborative networks, are needed to improve the understanding of the impact of SARS-CoV-2 infection in neonates.
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http://dx.doi.org/10.1136/archdischild-2020-319837DOI Listing
September 2020

COVID-19 Pandemic: Perspective of an Italian Tertiary Care Pediatric Center.

Healthcare (Basel) 2020 Sep 1;8(3). Epub 2020 Sep 1.

Department of Women's and Children's Health, University Hospital of Padua, Padua, Via Giustiniani 3, 35128 Padua, Italy.

Since February 2020, Italy has been faced with the dramatic spread of novel Coronavirus SARS-CoV-2. This impetuous pandemic infection forced many hospitals to reorganize their healthcare systems. Predicting a rapid spread of the SARS-CoV-2 virus within our region, the Department for Women's and Children's Health promptly decided (i) to revise the distribution of the clinical areas in order to create both designated COVID-19 and COVID-19-free areas with their own access, (ii) to reinforce infection prevention control (IPC) measures for all healthcare workers and administrative staff and (iii) to adopt the new "double-gate approach": a phone call pre-triage and nasopharyngeal swab for SARS-CoV-2 detection before the admission of all patients and caregivers. Between 21 February 2020 till 04 May 2020, only seven physicians, two nurses and two of the administrative staff resulted positive, all during the first week of March. No other cases of intra-department infection were documented among the healthcare workers since all the preventive procedures described above were implemented. It is predicted that similar situations can happen again in the future, and thus, it is necessary to be more prepared to deal with them than we were at the beginning of this COVID-19 pandemic.
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http://dx.doi.org/10.3390/healthcare8030311DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7551825PMC
September 2020

Presumed Risk Factors and Biomarkers for Severe Respiratory Syncytial Virus Disease and Related Sequelae: Protocol for an Observational Multicenter, Case-Control Study From the Respiratory Syncytial Virus Consortium in Europe (RESCEU).

J Infect Dis 2020 10;222(Suppl 7):S658-S665

Department of Paediatrics, Oxford Vaccine Group, Oxford, United Kingdom.

Respiratory syncytial virus (RSV) is the leading viral pathogen associated with acute lower respiratory tract infection and hospitalization in children < 5 years of age worldwide. While there are known clinical risk factors for severe RSV infection, the majority of those hospitalized are previously healthy infants. There is consequently an unmet need to identify biomarkers that predict host response, disease severity, and sequelae. The primary objective is to identify biomarkers of severe RSV acute respiratory tract infection (ARTI) in infants. Secondary objectives include establishing biomarkers associated with respiratory sequelae following RSV infection and characterizing the viral load, RSV whole-genome sequencing, host immune response, and transcriptomic, proteomic, metabolomic and epigenetic signatures associated with RSV disease severity. Six hundred thirty infants will be recruited across 3 European countries: the Netherlands, Spain, and the United Kingdom. Participants will be recruited into 2 groups: (1) infants with confirmed RSV ARTI (includes upper and lower respiratory tract infections), 500 without and 50 with comorbidities; and (2) 80 healthy controls. At baseline, participants will have nasopharyngeal, blood, buccal, stool, and urine samples collected, plus complete a questionnaire and 14-day symptom diary. At convalescence (7 weeks ± 1 week post-ARTI), specimen collection will be repeated. Laboratory measures will be correlated with symptom severity scores to identify corresponding biomarkers of disease severity.

Clinical Trials Registration: NCT03756766.
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http://dx.doi.org/10.1093/infdis/jiaa239DOI Listing
October 2020

Evidence on the Link between Respiratory Syncytial Virus Infection in Early Life and Chronic Obstructive Lung Diseases.

Am J Perinatol 2020 09 9;37(S 02):S26-S30. Epub 2020 Aug 9.

Department of Maternal-Infant Medicine, University Hospital "Degli Infermi," Ponderano, Biella, Italy.

There is growing evidence in medical literature to support an association between early-life respiratory syncytial virus lower respiratory tract-lower respiratory tract infection (RSV-LRTI) and recurrent wheezing/asthma-like symptoms. It has been estimated that children with a history of RSV-LRTI have a 2- to 12-fold higher risk of developing asthma. The connection between RSV infection and a developmental trajectory of reduced lung function remains throughout adolescence and early adulthood, suggesting a possible role for RSV even in the inception of chronic obstructive pulmonary disease. That is why the postnatal period appears to offer a specific window of opportunity for early intervention to prevent chronic obstructive lung diseases. The mechanisms by which RSV contributes to the onset of wheezing/asthma and lung function impairment are not fully understood but appear to relate to injury caused directly by the virus and/or to pre-existing predisposing factors. While awaiting a deeper understanding of the association between RSV and chronic lung diseases, the crucial role of pediatricians and physicians is to develop strategies to prevent RSV infections to try and protect children's lifelong respiratory health. KEY POINTS: · Several evidence suggest a link between RSV infection in early life and wheezing/asthma development.. · RSV infection appears to have long term respiratory effects.. · The prevention of RSV infections could reduce the incidence of chronic obstructive respiratory diseases..
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http://dx.doi.org/10.1055/s-0040-1714345DOI Listing
September 2020

Universal screening of high-risk neonates, parents, and staff at a neonatal intensive care unit during the SARS-CoV-2 pandemic.

Eur J Pediatr 2020 Dec 7;179(12):1949-1955. Epub 2020 Aug 7.

Department of Women's and Children's Health, Neonatal Intensive Care Unit, Padova University Hospital, Padova, Italy.

Since February 21, 2020, SARS-CoV-2 has spread exponentially worldwide. Neonatal patients needing intensive care are considered a vulnerable population. To report the results of a policy based on multi-timepoint surveillance for SARS-CoV-2 of all neonates admitted to the neonatal intensive care unit (NICU), their parents, and all healthcare providers in a part of Italy with a high prevalence of the infection. Observational study conducted from 21 February to 21 April 2020. Intervention consisted of (a) parental triage on arrival at the neonatal ward; (b) universal testing with nasopharyngeal swabs and blood testing for SARS-CoV-2 IgM and IgG antibodies; (c) use of continuous personal protective equipment at the NICU by parents and staff. A total of 6726 triage procedures were performed on 114 parents, and 954 nasopharyngeal swabs were collected from 226 individuals. Five (2.2%) asymptomatic individuals (2 parents and 3 healthcare providers) tested positive on nasopharyngeal swabs and were kept isolated for 14 days. Of 75 admitted newborn, no one tested positive on nasopharyngeal swabs or antibody tests. Three parents presented with fever or flu-like symptoms at triage; they tested negative on swabs.Conclusion: With universal screening of neonates, parents, and staff, there were no cases of SARS-CoV-2 infection among the neonates admitted to a NICU in an area with a high incidence of SARS-CoV-2. Our experience could be usefully compared with other strategies with a view to developing future evidence-based guidelines for managing high-risk neonates in case of new epidemics. What is Known: • The novel coronavirus named SARS-CoV-2 has since spread worldwide at a remarkable rate, with more than 2.5 million confirmed cases. • Pediatric population may be less affected from COVID-19 than adult population but infants and newborn babies seem to be more vulnerable to SARS-CoV-2 infection. What is New: • Using an approach based on triage; testing with nasopharyngeal swabs and serology; and use of personal protective equipment, there were no cases of SARS-CoV-2 infection among neonates in a NICU in a high incidence of SARS-CoV-2 area. • Positive and asymptomatic individuals were identified and isolated early allowing the containment of infection's spread among healthcare providers and parents.
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http://dx.doi.org/10.1007/s00431-020-03765-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7410953PMC
December 2020

Exploring respiratory syncytial virus prophylaxis for children with all grades of bronchopulmonary dysplasia.

Acta Paediatr 2021 01 3;110(1):25-27. Epub 2020 Aug 3.

Neonatology Service, Hospital Clinic, Institut d'Investigacions Biomediques August Pi Suñer, Barcelona, Spain.

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http://dx.doi.org/10.1111/apa.15482DOI Listing
January 2021

Mesenchymal stromal cells and their secreted extracellular vesicles as therapeutic tools for COVID-19 pneumonia?

J Control Release 2020 09 3;325:135-140. Epub 2020 Jul 3.

Department of Women's and Children's Health, University of Padova, Italy.

The COVID-19 epidemic represents an unprecedented global health emergency, further aggravated by the lack of effective therapies. For this reason, several clinical trials are testing different off-label drugs, already approved for other pathologies. Mesenchymal stem/stromal cells (MSCs) have been tested during the last two decades for the treatment of various pathologic conditions, including acute and chronic lung diseases, both in animal models and in patients. In particular, promising results have been obtained in the experimental therapy of acute respiratory distress syndrome, which represents the most threatening complication of COVID-19 infection. Furthermore, more recently, great interest has been devoted to the possible clinical applications of extracellular vesicles secreted by MSCs, nanoparticles that convey much of the biological effects and of the therapeutic efficacy of their cells of origin. This review summarizes the experimental evidence underlying the possible use of MSCs and of MSC-EVs in severe COVID-19 infection and underlines the need to evaluate the possible efficacy of these therapeutic approaches through controlled studies under the supervision of the Regulatory Authorities.
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http://dx.doi.org/10.1016/j.jconrel.2020.06.036DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7332437PMC
September 2020

Reply to correspondence: "Bronchiolitis needs a revisit: Distinguishing between virus entities and their treatments".

Allergy 2020 06;75(6):1531-1532

Women's and Children's Health Department, University of Padova, Padova, Italy.

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http://dx.doi.org/10.1111/all.14154DOI Listing
June 2020

Present and Future of Bronchopulmonary Dysplasia.

J Clin Med 2020 May 20;9(5). Epub 2020 May 20.

Neonatal Intensive Care Unit, Department of Women's and Children's Health, University of Padova, 35128 Padova, Italy.

Bronchopulmonary dysplasia (BPD) is the most common respiratory disorder among infants born extremely preterm. The pathogenesis of BPD involves multiple prenatal and postnatal mechanisms affecting the development of a very immature lung. Their combined effects alter the lung's morphogenesis, disrupt capillary gas exchange in the alveoli, and lead to the pathological and clinical features of BPD. The disorder is ultimately the result of an aberrant repair response to antenatal and postnatal injuries to the developing lungs. Neonatology has made huge advances in dealing with conditions related to prematurity, but efforts to prevent and treat BPD have so far been only partially effective. Seeing that BPD appears to have a role in the early origin of chronic obstructive pulmonary disease, its prevention is pivotal also in long-term respiratory outcome of these patients. There is currently some evidence to support the use of antenatal glucocorticoids, surfactant therapy, protective noninvasive ventilation, targeted saturations, early caffeine treatment, vitamin A, and fluid restriction, but none of the existing strategies have had any significant impact in reducing the burden of BPD. New areas of research are raising novel therapeutic prospects, however. For instance, early topical (intratracheal or nebulized) steroids seem promising: they might help to limit BPD development without the side effects of systemic steroids. Evidence in favor of stem cell therapy has emerged from several preclinical trials, and from a couple of studies in humans. Mesenchymal stromal/stem cells (MSCs) have revealed a reparatory capability, preventing the progression of BPD in animal models. Administering MSC-conditioned media containing extracellular vesicles (EVs) have also demonstrated a preventive action, without the potential risks associated with unwanted engraftment or the adverse effects of administering cells. In this paper, we explore these emerging treatments and take a look at the revolutionary changes in BPD and neonatology on the horizon.
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http://dx.doi.org/10.3390/jcm9051539DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7290764PMC
May 2020

Neonatal emergency transport system during COVID-19 pandemic in the Veneto Region: proposal for standard operating procedures.

Pediatr Res 2020 May 7. Epub 2020 May 7.

Neonatal Intensive Care Unit, Department of Woman's and Child's Health, University Hospital of Padova, Padova, Italy.

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http://dx.doi.org/10.1038/s41390-020-0937-zDOI Listing
May 2020

Neonatal Resuscitation Where the Mother Has a Suspected or Confirmed Novel Coronavirus (SARS-CoV-2) Infection: Suggestion for a Pragmatic Action Plan.

Neonatology 2020 24;117(2):133-140. Epub 2020 Apr 24.

Department of Woman and Child's Health, University Hospital of Padova, Padua, Italy.

Coronavirus disease 2019 (COVID-19), caused by the novel SARS-CoV-2 virus, is rapidly spreading across the world. As the number of infections increases, those of infected pregnant women and children will rise as well. Controversy exists whether COVID-19 can be transmitted in utero and lead to disease in the newborn. As this chance cannot be ruled out, strict instructions for the management of mothers and newborn infants are mandatory. This perspective aims to be a practical support tool for the planning of delivery and neonatal resuscitation of infants born by mothers with suspected or confirmed COVID-19 infection.
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http://dx.doi.org/10.1159/000507935DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7251577PMC
August 2020

Managing a tertiary-level NICU in the time of COVID-19: Lessons learned from a high-risk zone.

Pediatr Pulmonol 2020 06 21;55(6):1308-1310. Epub 2020 Apr 21.

Department of Women's and Children's Health, Neonatal Intensive Care Unit, University Hospital of Padua, Padua, Italy.

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http://dx.doi.org/10.1002/ppul.24788DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7264787PMC
June 2020

Fractional Exhaled Nitric Oxide (FENO) in the management of asthma: a position paper of the Italian Respiratory Society (SIP/IRS) and Italian Society of Allergy, Asthma and Clinical Immunology (SIAAIC).

Multidiscip Respir Med 2020 Jan 19;15(1):36. Epub 2020 Feb 19.

Italian Respiratory Society-Società Italiana di Pneumologia, Milan, Italy.

Asthma prevalence in Italy is on the rise and is estimated to be over 6% of the general population. The diagnosis of asthma can be challenging and elusive, especially in children and the last two decades has brought evidences that asthma is not a single disease but consists of various phenotypes. Symptoms can be underestimated by the patient or underreported to the clinician and physical signs can be scanty. Usual objective measures, like spirometry, are necessary but sometimes not significant. Despite proper treatment, asthma can be a very severe condition (even leading to death), however new drugs have recently become available which can be very effective in its control. Since asthma is currently thought to be caused by inflammation, a direct measure of the latter can be of paramount importance. For this purpose, the measurement of Fractional Exhaled Nitric Oxide (FE) has been used since the early years of the current century as a non-invasive, easy-to-assess tool useful for diagnosing and managing asthma. This SIP-IRS/SIAAIC Position Paper is a narrative review which summarizes the evidence behind the usefulness of FE in the diagnosis, management and phenotypization of asthma.
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http://dx.doi.org/10.4081/mrm.2020.36DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7137762PMC
January 2020

Pharmacokinetics, Safety and Antiviral Effects of Multiple Doses of the Respiratory Syncytial Virus Fusion Protein Inhibitor, JNJ-53718678, in Infants Hospitalized with RSV Infection: A Randomized Phase 1b Study.

Clin Infect Dis 2020 Mar 23. Epub 2020 Mar 23.

Global Clinical Development Infectious Diseases, Janssen Research & Development, Beerse, Belgium.

Background: This Phase 1b study evaluated the pharmacokinetics, safety and antiviral effects of the respiratory syncytial virus (RSV)-specific fusion inhibitor JNJ-53718678 (JNJ8678) in hospitalized RSVinfected patients (aged >1-≤24 months).

Methods: Patients categorized by age (Cohort 1: ≥6-≤24 months; Cohort 2: ≥3-<6 months; Cohort 3: >1-<3 months) were randomized to oral JNJ-8678 or placebo once-daily for 7 days. Dose increases followed Data Review Committee recommendations (doses respectively: Cohort 1: 2/6/8/9 mg/kg; Cohort 2: 1.5/4.5/6 mg/kg; Cohort 3: 1/3/5 mg/kg). Cohort 1 included a 9 mg/kg dose, as target exposures were not reached at lower doses. Sparse pharmacokinetic samples were assessed using population pharmacokinetics modeling. Safety was assessed by adverse events (AEs), laboratory tests and electrocardiograms. To assess antiviral effects, RSV RNA viral load from nasal swabs was quantified over time using qRT-PCR.

Results: Patients received JNJ-8678 (n=37) or placebo (n=7). Pharmacokinetic parameters were similar at the highest doses for Cohorts 1-3 (AUC24h at Day 7; 35,840, 34,980 and 39,627 ng.hr/mL, respectively). Two grade 3 AEs were reported (both bronchiolitis; 1 [JNJ-8678], 1 [placebo]); reported as serious AEs; all other AEs were grade 1 or 2. Two additional serious AEs were reported (rhinitis [JNJ-8678], pneumonia [placebo]). No deaths, grade 4 AEs or AEs leading to discontinuation were reported. Median RSV viral load change from baseline in JNJ-8678 vs placebo by Day 3 was 1.98 vs -0.32 log10 copies/mL.

Conclusion: In RSV-infected infants, JNJ-8678 was well tolerated. Target exposures were reached and antiviral activity was observed.
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http://dx.doi.org/10.1093/cid/ciaa283DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7744997PMC
March 2020

Caffeine in preterm infants: where are we in 2020?

ERJ Open Res 2020 Jan 2;6(1). Epub 2020 Mar 2.

Newborn Services, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.

The incidence of preterm birth is increasing, leading to a growing population with potential long-term pulmonary complications. Apnoea of prematurity (AOP) is one of the major challenges when treating preterm infants; it can lead to respiratory failure and the need for mechanical ventilation. Ventilating preterm infants can be associated with severe negative pulmonary and extrapulmonary outcomes, such as bronchopulmonary dysplasia (BPD), severe neurological impairment and death. Therefore, international guidelines favour non-invasive respiratory support. Strategies to improve the success rate of non-invasive ventilation in preterm infants include pharmacological treatment of AOP. Among the different pharmacological options, caffeine citrate is the current drug of choice. Caffeine is effective in reducing AOP and mechanical ventilation and enhances extubation success; it decreases the risk of BPD; and is associated with improved cognitive outcome at 2 years of age, and pulmonary function up to 11 years of age. The commonly prescribed dose (20 mg·kg loading dose, 5-10 mg·kg per day maintenance dose) is considered safe and effective. However, to date there is no commonly agreed standardised protocol on the optimal dosing and timing of caffeine therapy. Furthermore, despite the wide pharmacological safety profile of caffeine, the role of therapeutic drug monitoring in caffeine-treated preterm infants is still debated. This state-of-the-art review summarises the current knowledge of caff-eine therapy in preterm infants and highlights some of the unresolved questions of AOP. We speculate that with increased understanding of caffeine and its metabolism, a more refined respiratory management of preterm infants is feasible, leading to an overall improvement in patient outcome.
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http://dx.doi.org/10.1183/23120541.00330-2019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7049734PMC
January 2020

Early-life origin and prevention of chronic obstructive pulmonary diseases.

Pediatr Allergy Immunol 2020 02;31 Suppl 24:16-18

Department of Women's and Children's Health, University of Padova, Padova, Italy.

Chronic obstructive respiratory disorders such as asthma and chronic obstructive pulmonary disease (COPD) have their roots in the womb. Together with a genetic predisposition, prenatal and early-life factors, including maternal smoking, prematurity, and bronchopulmonary dysplasia (BPD), have a pivotal role in later respiratory health. Then, inappropriate responses to respiratory viruses (especially respiratory syncytial virus and rhinovirus) and early allergic sensitization are the strongest contributors to the inception of wheezing and early-onset asthma. There is an urgent need for early disease biomarkers to identify profiles at higher risk of chronic respiratory conditions. Applying the "-omic" technologies to urine, blood and breath condensate, and non-invasive inflammometry seem promising in this regard. The description of specific risk profiles may be the key to the use of targeted personalized therapies.
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http://dx.doi.org/10.1111/pai.13157DOI Listing
February 2020

New insights into pediatric community-acquired pneumonia gained from untargeted metabolomics: A preliminary study.

Pediatr Pulmonol 2020 02 10;55(2):418-425. Epub 2019 Dec 10.

Department of Women's and Children's Health, University of Padova, Padova, Italy.

Background: Available diagnostics often fail to distinguish viral from bacterial causes of pediatric community-acquired pneumonia (pCAP). Metabolomics, which aims at characterizing diseases based on their metabolic signatures, has been applied to expand pathophysiological understanding of many diseases. In this exploratory study, we used the untargeted metabolomic analysis to shed new light on the etiology of pCAP.

Methods: Liquid chromatography coupled with mass spectrometry was used to quantify the metabolite content of urine samples collected from children hospitalized for CAP of pneumococcal or viral etiology, ascertained using a conservative algorithm combining microbiological and biochemical data.

Results: Fifty-nine children with CAP were enrolled over 16 months. Pneumococcal and viral cases were distinguished by means of a multivariate model based on 93 metabolites, 20 of which were identified and considered as putative biomarkers. Among these, six metabolites belonged to the adrenal steroid synthesis and degradation pathway.

Conclusions: This preliminary study suggests that viral and pneumococcal pneumonia differently affect the systemic metabolome, with a stronger disruption of the adrenal steroid pathway in pneumococcal pneumonia. This finding may lead to the discovery of novel diagnostic biomarkers and bring us closer to personalized therapy for pCAP.
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http://dx.doi.org/10.1002/ppul.24602DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7168041PMC
February 2020

Nitric Oxide and Biological Mediators in Pediatric Chronic Rhinosinusitis and Asthma.

J Clin Med 2019 Oct 25;8(11). Epub 2019 Oct 25.

Women's and Children's Health Department, University of Padova, via Giustiniani 2, 35128 Padova, Italy.

Background: In the context of the so-called unified airway theory, chronic rhinosinusitis (CRS) and asthma may coexist. The inflammation underlying these conditions can be studied through the aid of biomarkers. Main body: We described the main biological mediators that have been studied in pediatric CRS and asthma, and, according to the available literature, we reported their potential role in the diagnosis and management of these conditions. As for CRS, we discussed the studies that investigated nasal nitric oxide (nNO), pendrin, and periostin. As for asthma, we discussed the role of fractional exhaled nitric oxide (feNO), the role of periostin, and that of biological mediators measured in exhaled breath condensate (EBC) and exhaled air (volatile organic compounds, VOCs).

Conclusion: Among non-invasive biomarkers, nNO seems the most informative in CRS and feNO in asthma. Other biological mediators seem promising, but further studies are needed before they can be applied in clinical practice.
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http://dx.doi.org/10.3390/jcm8111783DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6912805PMC
October 2019

Neonatal sepsis associated with Lactobacillus supplementation.

J Perinat Med 2019 12;48(1):87-88

Neonatal Intensive Care Unit, Department of Woman's and Child's Health, University of Padua, Padua, Italy.

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http://dx.doi.org/10.1515/jpm-2019-0268DOI Listing
December 2019

Intrauterine Growth Restriction: New Insight from the Metabolomic Approach.

Metabolites 2019 Nov 6;9(11). Epub 2019 Nov 6.

Neonatal Intensive Care Unit, Department of Women's and Children's Health, University of Padua, 35128 Padua, Italy.

Recognizing intrauterine growth restriction (IUGR) is a matter of great concern because this condition can significantly affect the newborn's short- and long-term health. Ever since the first suggestion of the "thrifty phenotype hypothesis" in the last decade of the 20th century, a number of studies have confirmed the association between low birth weight and cardiometabolic syndrome later in life. During intrauterine life, the growth-restricted fetus makes a number of hemodynamic, metabolic, and hormonal adjustments to cope with the adverse uterine environment, and these changes may become permanent and irreversible. Despite advances in our knowledge of IUGR newborns, biomarkers capable of identifying this condition early on, and stratifying its severity both pre- and postnatally, are still lacking. We are also still unsure about these babies' trajectory of postnatal growth and their specific nutritional requirements with a view to preventing, or at least limiting, long-term complications. In this setting, untargeted metabolomics-a relatively new field of '-omics' research-can be a good way to investigate the metabolic perturbations typically associated with IUGR. The aim of this narrative review is to provide a general overview of the pathophysiological and clinical aspects of IUGR, focusing on evidence emerging from metabolomic studies. Though still only preliminary, the reports emerging so far suggest an "early" pattern of glucose intolerance, insulin resistance, catabolite accumulation, and altered amino acid metabolism in IUGR neonates. Further, larger studies are needed to confirm these results and judge their applicability to clinical practice.
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http://dx.doi.org/10.3390/metabo9110267DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6918259PMC
November 2019