Stillbirths: results of a pilot population-based surveillance system in Italy (SPItOSS)

OBJECTIVES: to describe the results of a pilot population-based perinatal mortality surveillance system, with regards to stillbirths; to study maternal, obstetric, and foetal characteristics, evaluating risk factors and understanding causes. DESIGN: a cross-sectional study was conducted on incident cases of stillbirths collected by the surveillance system from July 2017 to June 2019 in three Italian Regions (Lombardy, Tuscany, and Sicily). SETTING AND PARTICIPANTS: data on stillbirths, resulting from the in-hospital multidisciplinary audits, organised using the Significant Event Audit methodology, were analysed. According to the World Health Organization (WHO) definitions, the project identified stillbirths as foetuses born dead >=28 weeks of gestation. The WHO International Classification of Diseases-Perinatal Mortality was used to categorise the causes of foetal death. MAIN OUTCOMES MEASURES: maternal characteristics, obstetric and foetal findings were investigated. Unadjusted relative risks and 95% confidence intervals were computed with respect to the background population. Finally, causes of death and contributing maternal conditions have been considered. RESULTS: the maternity and neonatal units of the three participating Regions notified 520 stillbirths, of which 435 cases underwent to the multidisciplinary audit (83.7%); 40.0% of cases occurred in the gestational age range between 36 and 39 weeks. The risk of stillbirth was significantly increased in mothers with foreign citizenship (RR: 1.39; 95%CI: 1.13-1.71), multiple pregnancies (RR: 1.59; 95%CI 1.05-2.42), and pregnancies conceived with assisted reproductive technologies (RR: 2.15; 95%CI 1.45-3.19). The rate of congenital malformations was 6.0%. A diagnosis of foetal growth restriction was reported in 10.3% of cases, although the percentage of dead foetuses weighting <10° centile was at least twice in almost all gestational age periods. Post-mortem and placental histological examinations were carried out in more than 70% and more than 90% of cases, respectively. CONCLUSIONS: the implementation of a population-based surveillance system with high participation rate of maternity units and the use of universally accepted definitions could improve the identification of stillbirth avoidable risk factors and potentially modifiable predisposing maternal conditions, highlighting issues of perinatal assistance in need of improvement.

Opioids for newborn infants receiving mechanical ventilation.

BACKGROUND: Mechanical ventilation is a potentially painful and discomforting intervention that is widely used in neonatal intensive care. Newborn infants demonstrate increased sensitivity to pain, which may affect clinical and neurodevelopmental outcomes. The use of drugs that reduce pain might be important in improving survival and neurodevelopmental outcomes. OBJECTIVES: To determine the benefits and harms of opioid analgesics for neonates (term or preterm) receiving mechanical ventilation compared to placebo or no drug, other opioids, or other analgesics or sedatives. SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 9), in the Cochrane Library; MEDLINE via PubMed (1966 to 29 September 2020); Embase (1980 to 29 September 2020); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to 29 September 2020). We searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials comparing opioids to placebo or no drug, to other opioids, or to other analgesics or sedatives in newborn infants on mechanical ventilation. We excluded cross-over trials. We included term (≥ 37 weeks' gestational age) and preterm (< 37 weeks' gestational age) newborn infants on mechanical ventilation. We included any duration of drug treatment and any dosage given continuously or as bolus; we excluded studies that gave opioids to ventilated infants for procedures. DATA COLLECTION AND ANALYSIS: For each of the included trials, we independently extracted data (e.g. number of participants, birth weight, gestational age, types of opioids) using Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria and assessed the risk of bias (e.g. adequacy of randomisation, blinding, completeness of follow-up). We evaluated treatment effects using a fixed-effect model with risk ratio (RR) for categorical data and mean difference (MD) for continuous data. We used the GRADE approach to assess the certainty of evidence. MAIN RESULTS: We included 23 studies (enrolling 2023 infants) published between 1992 and 2019. Fifteen studies (1632 infants) compared the use of morphine or fentanyl versus placebo or no intervention. Four studies included both term and preterm infants, and one study only term infants; all other studies included only preterm infants, with five studies including only very preterm infants. We are uncertain whether opioids have an effect on the Premature Infant Pain Profile (PIPP) Scale in the first 12 hours after infusion (MD -5.74, 95% confidence interval (CI) -6.88 to -4.59; 50 participants, 2 studies) and between 12 and 48 hours after infusion (MD -0.98, 95% CI -1.35 to -0.61; 963 participants, 3 studies) because of limitations in study design, high heterogeneity (inconsistency), and imprecision of estimates (very low-certainty evidence - GRADE). The use of morphine or fentanyl probably has little or no effect in reducing duration of mechanical ventilation (MD 0.23 days, 95% CI -0.38 to 0.83; 1259 participants, 7 studies; moderate-certainty evidence because of unclear risk of bias in most studies) and neonatal mortality (RR 1.12, 95% CI 0.80 to 1.55; 1189 participants, 5 studies; moderate-certainty evidence because of imprecision of estimates). We are uncertain whether opioids have an effect on neurodevelopmental outcomes at 18 to 24 months (RR 2.00, 95% CI 0.39 to 10.29; 78 participants, 1 study; very low-certainty evidence because of serious imprecision of the estimates and indirectness). Limited data were available for the other comparisons (i.e. two studies (54 infants) on morphine versus midazolam, three (222 infants) on morphine versus fentanyl, and one each on morphine versus diamorphine (88 infants), morphine versus remifentanil (20 infants), fentanyl versus sufentanil (20 infants), and fentanyl versus remifentanil (24 infants)). For these comparisons, no meta-analysis was conducted because outcomes were reported by one study. AUTHORS' CONCLUSIONS: We are uncertain whether opioids have an effect on pain and neurodevelopmental outcomes at 18 to 24 months; the use of morphine or fentanyl probably has little or no effect in reducing the duration of mechanical ventilation and neonatal mortality. Data on the other comparisons planned in this review (opioids versus analgesics; opioids versus other opioids) are extremely limited and do not allow any conclusions. In the absence of firm evidence to support a routine policy, opioids should be used selectively - based on clinical judgement and evaluation of pain indicators - although pain measurement in newborns has limitations.

Neonatal Air Medical Transportation Practices in Italy: A Nationwide Survey.

The present article shows the current neonatal air transport organization and activity in Italy. The results were obtained on the basis of a recent 2019 survey (year of activity 2018) performed by the Neonatal Transport Study Group of the Italian Society of Neonatology. The total number of newborn transports during the year 2018 was 6,464. The air-suitable transports were 512 of 5,852 (8.74%), and among them, 101 of 512 (19.72%) were performed by helicopter and 34 by airplane. Besides the availability of air transport, the interfacility distance, weather and traffic conditions, and rural mountainous roads were the main factors in determining the vehicle choice. Neonatal air transport in Italy is not homogeneously distributed and needs organizational corrections. The high density of neonatal emergency transport services on the national territory indicates the need to overcome the limits imposed by regional administrative borders, thus expanding the geographic area of competence.

Managerial features and outcome in neonatal intensive care units: results from a cluster analysis.

BACKGROUND: Healthcare organisations differ in performance even if they are located in the same country or region. Suitable managerial practices and organisational processes can lead to better health outcomes. As a result, hospitals are constantly looking for managerial arrangements that can improve outcomes and keep costs down. This study aims to identify different managerial models in neonatal intensive care units (NICUs) and their impact on a large number of outcomes. METHODS: The research was conducted in Italy, within the SONAR project. SONAR's aim was to identify the characteristics of NICUs, monitor outcomes and promote best practices. This study includes 51 of the 63 NICUs that took part in the SONAR project. Questionnaires on the activities and managerial features were administered to doctors and nurses working in NICUs. A total of 643 questionnaires were analysed from doctors and a total of 1601 from nurses. A cluster analysis was performed to identify managerial models of NICUs. RESULTS: Three managerial models emerged from cluster analysis: traditional, collaborative and individualistic. In the "traditional" model the doctor is above the nurse in the hierarchy, and the nurse therefore has exclusively operational autonomy. The "collaborative" model has as key elements professional specialisation and functional coordination. The "individualistic" model considers only individual professional skills and does not concern the organisational conditions necessary to generate organisational effectiveness. The results also showed that there is an association between managerial model and neonatal outcomes. The collaborative model shows best results in almost all outcomes considered, and the traditional model has the worst. The individualistic model is in the middle, although its values are very close to those of traditional model. CONCLUSIONS: Health management needs to assess NICU strategically in order to develop models to improve outcomes. This study provides insights for management useful for designing managerial characteristics of NICUs in order to achieve better results. NICUs characterised by a collaborative model in fact show better neonatal outcomes.

Antenatal Corticosteroid Prophylaxis in Singleton and Multiple Pregnancies.

BACKGROUND: The effects of antenatal corticosteroids (ANS) in multiple pregnancies are disputed. In this article, we examined whether estimated effects differ in singletons and multiples and in small for gestational age (SGA) preterm infants. METHODS: We studied 17 073 singletons (81% treated with ANS) and 8274 multiples (86% treated) born at 24-33 weeks from the Italian Neonatal Network (2005-2013). We used Poisson regression models with robust variance to estimate adjusted risk ratios (RR) of in-hospital death, severe intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL), and the composite outcome of severe IVH and death. RESULTS: Mortality was lower among ANS-treated vs. ANS-untreated infants, both in singletons (RR 0.63, 95% confidence interval (CI) 0.58, 0.68) and in multiples (RR 0.85, 95% CI 0.73, 0.98). IVH and the composite outcome of IVH and death, but not PVL, also occurred less frequently among ANS-treated infants. For these outcomes, the effect of ANS was stronger in singletons than in multiples (+35%, +32%, and +22% for death, IVH, and the composite outcome, respectively). Also among SGA infants, singletons, and multiples, ANS-treated infants had lower risk of death, IVH and of composite outcome than untreated ones. CONCLUSIONS: In this large cohort of preterm infants, both multiples and singletons treated with ANS had a lower risk of mortality, of severe IVH, and of composite outcome of IVH and death, both in the overall sample and in SGA infants. Although ANS effect was weaker in multiples, our results support current recommendations to administer ANS prophylaxis in multiple pregnancies at risk of preterm delivery.

Left bundle branch block: from cardiac mechanics to clinical and diagnostic challenges.

Left bundle branch block (LBBB) results in an altered pattern of left ventricular (LV) activation and subsequent contraction, causing remarkable changes in LV mechanics, perfusion and workload and ultimately leading to pathologic cardiac remodelling. Clinical and diagnostic notions about the LBBB phenomenon had evolved from just an electrocardiographic pattern to a critically important finding affecting diagnostic and clinical management of many patients and adversely influencing their outcomes. Recent advances in imaging techniques significantly improved the assessment of patients with LBBB and provided additional insights into pathophysiological mechanisms of LV remodelling. In the current review we summarized currently available data on the LBBB epidemiology, diagnosis, its impact on clinical management and prognosis, and the role and place of various imaging modalities in assessing cardiac mechanics and perfusion abnormalities, as well as their potential implications for diagnostic and treatment strategies.

Does quality of developmental care in NICUs affect health-related quality of life in 5-y-old children born preterm?

BACKGROUND: Preterm birth and Neonatal Intensive Care Unit (NICU) stay are early adverse experiences, which may affect health-related quality of life (HRQoL) even in the absence of prematurity-related morbidities. The aim of this multicenter longitudinal study was to examine the relation between quality levels of NICU Developmental Care (DC) and HRQoL at 60 mo in children who were born preterm. METHODS: HRQoL of 102 very preterm (VPT) children from 20 NICUs and 110 full-term controls was assessed using TNO-AZL Preschool Children's Quality of Life Questionnaire (TAPQOL). In VPT children, we compared HRQoL by splitting NICUs into units with high- and low-quality of DC according to the following two factors: (i) the infant centered care (ICC), and (ii) the infant pain management (IPM). RESULTS: Compared to VPT children from NICUs with high-quality of ICC, VPT children from NICUs with low-quality in ICC scored lower in HRQoL component which resulted from the aggregation of lively, positive emotionality, social and motor functioning. No differences were found between VPT children from high-quality ICC NICUs and full-term children and for the IPM index. CONCLUSION: Findings suggest that higher quality of DC in NICU related to ICC might mitigate long-term negative quality of life outcomes.

Coronary microvascular dysfunction induced by primary hyperparathyroidism is restored after parathyroidectomy.

BACKGROUND: Symptomatic primary hyperparathyroidism (PHPT) is associated with increased cardiovascular mortality. However, data on the association between asymptomatic PHPT and cardiovascular risk are lacking. We assessed coronary flow reserve (CFR) as a marker of coronary microvascular function in asymptomatic PHPT of recent onset. METHODS AND RESULTS: We studied 100 PHPT patients (80 women; age, 58±12 years) without cardiovascular disease and 50 control subjects matched for age and sex. CFR in the left anterior descending coronary artery was detected by transthoracic Doppler echocardiography, at rest, and during adenosine infusion. CFR was the ratio of hyperemic to resting diastolic flow velocity. CFR was lower in PHPT patients than in control subjects (3.0±0.8 versus 3.8±0.7; P<0.0001) and was abnormal (≤2.5) in 27 patients (27%) compared with control subjects (4%; P=0.0008). CFR was inversely related to parathyroid hormone (PTH) levels (r=-0.3, P<0.004). In patients with CFR ≤2.5, PTH was higher (26.4 pmol/L [quartiles 1 and 3, 16 and 37 pmol/L] versus 18 [13-25] pmol/L; P<0.007), whereas calcium levels were similar (2.9±0.1 versus 2.8±0.3 mmol/L; P=0.2). In multivariable linear regression analysis, PTH, age, and heart rate were the only factors associated with CFR (P=0.04, P=0.01, and P=0.006, respectively). In multiple logistic regression analysis, only PTH increased the probability of CFR ≤2.5 (P=0.03). In all PHPT patients with CFR ≤2.5, parathyroidectomy normalized CFR (3.3±0.7 versus 2.1±0.5; P<0.0001). CONCLUSIONS: PHPT patients have coronary microvascular dysfunction that is completely restored after parathyroidectomy. PTH independently correlates with the coronary microvascular impairment, suggesting a crucial role of the hormone in explaining the increased cardiovascular risk in PHPT.

Presence of human milk bank is associated with elevated rate of exclusive breastfeeding in VLBW infants.

Human milk confers health benefits of vital importance for the sick and preterm infants in neonatal intensive care units (NICUs). Mother's own milk is the first choice in preterm infant feeding, and every effort should be made to promote lactation. When mother's milk is not available or is insufficient, donor human milk (DHM) is recommended. Yet, occasionally, the concern that the use of DHM might decrease breastfeeding is being raised. The present data collection planned by the Italian Association of Human Milk Banks (AIBLUD) in collaboration with the Italian Neonatal Network (INN) attempted to address this concern. A total of 4277 very low birth weight (VLBW) infants from 83 Italian NICUs were evaluated for this comparative analysis. The 83 Italian NICUs were divided into two groups: centers with a human milk bank (HMB) and centers without a HMB; the available parameters in the network--"any and exclusive breastfeeding rates" and "exclusive formula rate" at discharge--were compared. Exclusive breastfeeding rate at discharge was significantly higher in NICUs with a HMB than in NICUs without (29.6% vs. 16.0%, respectively). Any breastfeeding rate at discharge tended to be higher in the NICUs with HMB (60.4% vs. 52.8%, P = 0.09), and exclusive formula rate was lower in the NICUs with HMB (26.5% vs. 31.3%), but this difference was not significant. This report shows that the presence of a HMB and the use of DHM in NICU are associated with increased breastfeeding rate at discharge from the hospital for VLBW infants.

Survey of neonatal respiratory care and surfactant administration in very preterm infants in the Italian Neonatal Network.

INTRODUCTION: Variation of respiratory care is described between centers around the world. The Italian Neonatal Network (INN), as a national group of the Vermont-Oxford Network (VON) allows to perform a wide analysis of respiratory care in very low birth weight infants. METHODS: We analyzed the dataset of infants enrolled in the INN in 2009 and 2010 and, for surfactant administration only, from 2006 to 2010 from 83 participating centers. All definitions are those of the (VON). A questionnaire analysis was also performed with a questionnaire on centers practices. RESULTS: We report data for 8297 infants. Data on ventilator practices and outcomes are outlined. Variation for both practices and outcome is found. Trend in surfactant administration is also analyzed. CONCLUSIONS. The great variation across hospitals in all the surveyed techniques points to the possibility of implementing potentially better practices with the aim of reducing unwanted variation. These data also show the power of large neonatal networks in identifying areas for potential improvement.

Wearable monitoring systems in pre-term newborns care.

In the last decade, the trends in the development and management of healthcare services are focused on the personalization of prevention, diagnosis and treatment. This paper presents an example of the development of wearable technology for biosignal monitoring in the field of pre-term newborns care. The system was validated by an in-hospital pre-clinical test demonstrating efficiency, reliability and quality.

Coronary computed tomography angiography in acute chest pain: A sustainable model with remote support.

PURPOSE: To propose a sustainable model of coronary computed tomography angiography (CCTA) use in acute coronary syndrome (ACS) in emergency department (ED) using a partially based teleradiology reporting model. We also analyzed impact of the protocol on short- and long-term patient's outcome. METHODS: During a 12-month period, 104 consecutive patients admitted to the ED for acute chest pain (ACP) with low-to-intermediate risk of ACS were selected and underwent CCTA. Medical reporting was based on a model combining on-site physician and a remote radiologist supported by a web client-based teleradiology system, covering a 24/7 service. CCTA findings were correlated with the incidence of major adverse cardiovascular events (MACEs) over a 5-year follow-up. RESULTS: CCTA ruled-out CAD in 76 patients (73.1%). Moderate (7.7%) to severe (19.2%) CAD was identified in 28 patients who were directly referred to functional tests or invasive angiography. The mean discharge time was 10.8 ± 5.8 h; patients with absent to mild disease were safely and quickly discharged. Remote reporting using a teleradiology platform was performed in 82/104 cases (78.9%), with slight impact on patient's discharge time (10.4 ± 5.6 vs. 12.1 ± 6.1 h, p: 0.24). MACEs at 6-month and at 5-year follow-up were 0.96% (n = 1/104) and 15.5% (n = 14/90). CONCLUSION: CCTA assessment of patients with ACP enables to quickly rule-out ACS, avoiding waste of time and resources, to identify patients with obstructive CAD which should be referred to subsequent tests and to stratify the risk of MACEs at short and long time. A partial teleradiology based 24/7 CCTA service is feasible and sustainable, even in small ED.

OPHTHALMIA NEONATORUM in Italy: it is time for change.

Ophthalmia neonatorum (ON) refers to any conjunctivitis occurring in the first 28 days of life. In the past Neisseria gonorrhoeae was the most common cause of ON. It decreased with the introduction of prophylaxis at birth with the instillation of silver nitrate 2% (the Credè's method of prophylaxis). Today, the term ON is used to define any other bacterial infection, in particular due to Chlamydia Trachomatis. Currently, the WHO reccomends topical ocular prophylaxis for prevention of gonococcal and chlamydial conjunctivitis for all neonates. On the contrary, several European countries no longer require universal prophylaxis, opting for screening and treatment of pregnant women at high risk of infection. And what about Italy? Have a look on Italian history of prophylaxis, starting by the first decree issued in 1940, signed by Benito Mussolini. In the following decades the law has undergone many changes. At the moment, legislation is unclear, therefore careful consideration is required in order to draft the correct appoach.

Transapical off-pump echo-guided mitral valve repair with neochordae implantation mid-term outcomes.

BACKGROUND: The NeoChord echo-guided transapical beating heart repair is a promising early-stage minimally invasive surgical procedure for degenerative mitral valve (MV) regurgitation (DMR) correction. The technique has been improved since its inception following procedure standardization, patient selection optimization, and learning curve stabilization. We hereby present the mid-term clinical results through three years of our large single center experience. METHODS: All consecutive patients with severe symptomatic DMR due to prolapse or flail of one or both mitral leaflets that underwent the NeoChord procedure between November 2013 and June 2019 were included. Patients were categorized according to MV anatomy; Type A isolated central posterior leaflet prolapse and/or flail, Type B posterior multi-segment prolapse and/or flail, Type C anterior and/or bi-leaflet prolapse or flail, Type D paracommissural prolapse and/or flail and/or significant leaflet and/or annular calcifications. Patients underwent clinical and echocardiographic follow-up at one, three, six, twelve months and yearly thereafter. Clinical outcomes and the composite primary endpoint (patient success) were defined according to Mitral Valve Academic Research Consortium (MVARC) criteria. Mitral regurgitation (MR) severity was graded as absent, mild, moderate and severe according to American Society of Echocardiography (ASE) and European Society of Cardiology (ESC) guidelines. RESULTS: Two hundred and three patients were included; median follow-up was 24 months [interquartile range (IQR), 9-36]. Median age was 64 years (IQR, 54-74 years), median Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) was 0.60% (IQR, 0.32-1.44%). There were 106 Type A patients (52.2%), 68 Type B (33.5%), 16 Type C (7.9%), and 13 Type D (6.4%). Kaplan-Meier estimate of survival was 99.0%±0.7% at one and two years and 94.0%±2.9% at three years. At one-year follow-up patient success was 91.2%±2.0% and 111 patients (74%) presented a residual MR mild or less (1+). At three-year follow-up patient success was 81.2%±3.8% and 32 patients (64%) had a residual MR mild or less (1+). Patient success was significantly different according to anatomical type (P=0.001). Echocardiographic analysis showed a significant acute left ventricle and left atrial reverse remodeling that was maintained up to three years. CONCLUSIONS: The NeoChord echo-guided transapical beating heart repair procedure demonstrated good clinical outcomes and echocardiographic results up to three-year follow-up.

Acute Rheumatic Fever: Where Do We Stand? An Epidemiological Study in Northern Italy.

Acute rheumatic fever (ARF) is a non-septic complication of group A ß-hemolytic streptococcal (GAS) throat infection. Since 1944, ARF diagnosis relies on the Jones criteria, which were periodically revised. The 2015 revision of Jones criteria underlines the importance of knowing the epidemiological status of its own region with updated data. This study aims to describe ARF features in a retrospective cohort retrieved over a 10-year timespan (2009-2018) and to report the annual incidence of ARF among children in the Province of Monza-Brianza, Lombardy, Italy during the same period. This is a multicentric cross-sectional/retrospective study; 70 patients (39 boys) were diagnosed with ARF. The median age at diagnosis was 8.5 years (range, 4-14.2 years). Overall, carditis represented the most reported major Jones criteria followed by arthritis and chorea (40, 27, and 20 cases, respectively). In order to calculate the annual incidence of ARF, only children resident in the Province of Monza-Brianza were included in this part of the analysis. Therefore, 47 patients aged between 5 and 14 years were identified. The median incidence during the study time was 5.7/100,000 (range, 2.8-8.3/100,000). In the Province of Monza-Brianza, we found an incidence rate of ARF among children aged 5-14 years constantly above the threshold of low-risk area as defined in the 2015 revision of Jones criteria. Therefore, the diagnosis of ARF should be based on the moderate-high-risk set of Jones criteria. However, given the burden of secondary prophylaxis, expert opinion is advisable when the diagnosis of ARF is uncertain.

Neuroprem: the Neuro-developmental outcome of very low birth weight infants in an Italian region.

INTRODUCTION: The survival of preterm babies has increased worldwide, but the risk of neuro-developmental disabilities remains high, which is of concern to both the public and professionals. The early identification of children at risk of neuro-developmental disabilities may increase access to intervention, potentially influencing the outcome. AIMS: Neuroprem is an area-based prospective cohort study on the neuro-developmental outcome of very low birth weight (VLBW) infants that aims to define severe functional disability at 2 years of age. METHODS: Surviving VLBW infants from an Italian network of 7 neonatal intensive care units (NICUs) were assessed for 24 months through the Griffiths Mental Developmental Scales (GMDS-R) or the Bayley Scales of Infant and Toddler Development (BSDI III) and neuro-functional evaluation according to the International Classification of Disability and Health (ICF-CY). The primary outcome measure was severe functional disability at 2 years of age, defined as cerebral palsy, a BSDI III cognitive composite score < 2 standard deviation (SD) or a GMDS-R global quotients score < 2 SD, bilateral blindness or deafness. RESULTS: Among 211 surviving VLBW infants, 153 completed follow-up at 24 months (72.5%). Thirteen patients (8.5%) developed a severe functional disability, of whom 7 presented with cerebral palsy (overall rate of 4.5%). Patients with cerebral palsy were all classified with ICF-CY scores of 3 or 4. BSDI III composite scores and GMDS-R subscales were significantly correlated with ICF-CY scores (p < 0.01). CONCLUSION: Neuroprem represents an Italian network of NICUs aiming to work together to ensure preterm neuro-developmental assessment. This study updates information on VLBW outcomes in an Italian region, showing a rate of cerebral palsy and major developmental disabilities in line with or even lower than those of similar international studies. Therefore, Neuroprem provides encouraging data on VLBW neurological outcomes and supports the implementation of a preterm follow-up programme from a national network perspective.

Bronchopulmonary dysplasia and brain white matter damage in the preterm infant: a complex relationship.

We analysed the relationship between bronchopulmonary dysplasia (BPD) and brain white matter damage (WMD) in very preterm infants, adjusting for common risk factors and confounders. We studied a cohort of infants <32 weeks gestational age (GA) and <1500 g, admitted to 12 hospitals in Northern Italy in 1999-2002. The association between BPD and WMD was estimated by generalised estimating equations and conditional logistic models, adjusting for centre, GA, propensity score for prolonged ventilation and other potential confounders. Directed acyclic graphs (DAG) were used to depict the underlying causal structure and guide analysis. Of the 1209 infants reaching 36 weeks, 192 (15.8%) developed BPD (supplemental oxygen at 36 weeks) and 88 (7.3%) ultrasound-defined WMD (cystic periventricular leukomalacia). In crude analysis, BPD was a strong risk factor for WMD [odds ratio (OR) = 5.9]. With successive adjustments, the OR progressively decreased to 3.88 when adjusting for GA, to 2.72 adding perinatal risk factors, and further down to 2.16 [95% confidence interval 1.1, 3.9] when ventilation was also adjusted for. Postnatal factors did not change the OR. Significant risk factors for WMD, in addition to BPD, were a low GA, a lower Apgar score, a higher illness severity score, ventilation and early-onset sepsis, while antenatal steroids, being small for GA, and surfactant were associated with a reduced risk. In conclusion, our data suggest that BPD is associated with an increased risk of WMD; most of the effect is due to shared risk factors and causal pathways. DAGs helped clarify the complex confounding of this scenario.

Mechanisms of recurrent regurgitation after transapical off-pump mitral valve repair with neochord implantation†.

OBJECTIVES: The aim of this study was to describe possible mechanisms of recurrent mitral regurgitation (MR) in patients who have been treated with the NeoChord procedure. METHODS: Patients presenting with recurrent severe or moderate MR were categorized as Not Expected Surgical-Like Result (NESLR)-Redo and NESLR-MR2 [NESLR reintervention or moderate MR (2+), respectively]. NESLR patients were stratified by onset (intraoperative, perioperative 24 h-30 days, or early 30 days to follow-up), by MR jet direction (central or eccentric) and by jet orientation (anterior or posterior). Specific mechanisms of NESLR were analysed. RESULTS: Fifty-two patients were identified with 13 (25%) categorized as NESLR-Redo, and 39 (75%) as NESLR-MR2. NESLR-Redo patient stratification included: intraoperative = 2 patients (1.2%), both eccentric anteriorly directed jets; perioperative = 7 patients (4.2%), all eccentric with 3 anteriorly and 4 posteriorly directed jets; and early = 4 patients (2.4%), 1 central, 3 eccentric, 2 posteriorly and 1 anteriorly directed jets. NESLR-MR2 patient stratification included: perioperative = 2 patients (5.1%), both eccentric, 1 anteriorly and 1 posteriorly directed jets; and early = 37 patients (94.9%), 4 central, 33 eccentric, 22 anteriorly and 11 posteriorly directed jets. Possible mechanisms of recurrent MR were identified as: patient selection (17.3%), technical issues (28.8%), progression of baseline disease (15.4%), left ventricle reverse remodelling (1.9%), excessive over-tensioning (35.8%) and PML curling (30.8%). CONCLUSIONS: The mechanisms of recurrent MR after the NeoChord procedure can be determined. Understanding recurrent MR mechanisms has led to improvements in procedural standardization and ad hoc prevention strategies that have been widely adopted since our initial clinical experience.

Necrotising enterocolitis in very low birth weight infants in Italy: incidence and non-nutritional risk factors.

Incidence and non-nutritional risk factors were estimated for necrotising enterocolitis in 2035 very low birth weight infants, admitted to 14 tertiary-level neonatal intensive care units in Lombardy, northern Italy. There were 62 necrotising enterocolitis cases, with an overall incidence of 3.1%. After adjustment for gestational age and centre, the risk factors were mechanical ventilation, patent ductus arteriosus, and late-onset sepsis, whereas surfactant treatment was associated with decreased risk. Significant variations in necrotising enterocolitis incidence among hospitals were found.