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Objective: To investigate differences by gestational age in emergency department visits and re-hospitalizations during the three years following childbirth discharge., Methods: We performed a historical cohort study in Lazio Region, Italy, for infants born in 2007-2008 to resident mothers. Health administrative data were used. Analysis was performed by multinomial logistic regression., Results: Of 90 545 infants, more than 50% had at least one emergency department visit, and 18.8% at least one re-hospitalization. After the exclusion of infants with congenital anomalies, relative risk ratios of re-hospitalization and, to a lesser extent, of emergency department visits increased by decreasing gestational age; the two events were also higher for mothers ≤35 years of age, with low education and of Italian nationality. Residency outside the metropolitan area was associated with an increased risk of re-hospitalization and a decreased risk of emergency department visits., Conclusion: During the three years following childbirth discharge, re-hospitalizations and, to a lesser extent, emergency department use are inversely related to gestational age at birth; socio-demographic factors have an effect on the risk of infant use of hospital resources independent of gestational age.

Objective: Organizational features of neonatal intensive care influence the care of sick neonates. We estimated the acuity-adjusted nurse-to-patient ratio (NPR) in a national sample of Italian NICUs and factors influencing it., Methods: Twelve monthly cross-sectional surveys were prospectively carried out in 63 NICUs. Number and acuity of infants, and number of nurses were recorded. Infants' acuity was assessed by Rogowki's 2013 and British Association for Perinatal Medicine 2001 classifications., Results: We collected 702 reports regarding 11 082 infants. Non-intensive infants represented about 75% of NICU residents. Very preterm infants (<1501 g birth weight or <30 weeks gestation) represented 10.8% of admissions, but 44% of all infants surveyed. Average acuity-adjusted NPR was 0.31 (interquartile range 0.28-0.38); NPR depended on case-mix (proportion of intensive infants), size of the unit (larger units had a lower NPR) and was higher during morning shifts (+18%). Clustering on hospitals, reflecting shared components within each hospital, explained 47% of the variability of NPR., Conclusions: The majority of infants cared for in NICUs are not intensive. NPR is influenced by acuity of infants, size of units, shifts, but is largely due to other unobserved hospital-related organizational features.

Background: Neonatal units' volume of activity, and other quantitative and qualitative variables, such as staffing, workload, work environment, care organization and geographical location, may influence the outcome of high risk newborns. Data about the distribution of these variables and their relationships among Italian neonatal units are lacking., Methods: Between March 2010-April 2011, 63 neonatal intensive care units adhering to the Italian Neonatal Network participated in the SONAR Nurse study. Their main features and work environment were investigated by questionnaires compiled by the chief and by physicians and nurses of each unit. Twelve cross-sectional monthly-repeated surveys on different shifts were performed, collecting data on number of nurses on duty and number and acuity of hospitalized infants., Results: Six hundred forty five physicians and 1601 nurses compiled the questionnaires. In the cross-sectional surveys 702 reports were collected, with 11082 infant and 3226 nurse data points. A high variability was found for units' size (4-50 total beds), daily number of patients (median 14.5, range 3.4-48.7), number of nurses per shift (median 4.2, range 0.7-10.8) and number of team meetings per month. Northern regions performed better than Central and Southern regions for frequency of training meetings, qualitative assessment of performance, motivation within the unit and nursing work environment; mean physicians' and nurses' age increased moving from North to South. After stratification by terciles of the mean daily number of patients, the median number of nurses per shift increased at increasing volume of activity, while the opposite was found for the nurse-to-patient ratio adjusted by patients' acuity. On average, in units belonging to the lower tercile there was 1 nurse every 2.5 patients, while in those belonging to the higher tercile the ratio was 1 nurse every 5 patients., Conclusions: In Italy, there is a high variability in organizational characteristics and work environment among neonatal units and an uneven distribution of human resources in relation to volume of activity, suggesting that the larger the unit the greater the workload for each nurse. Urgent modifications in planning and organization of services are needed in order to pursue more efficient, homogeneous and integrated regionalized neonatal care systems.

Background: The use of assisted conception (AC) has been associated with higher risk of adverse perinatal outcome. Few data are available on the outcome of AC-neonates when pregnancy ends before 32 weeks of gestational age.The aim of this study was to compare the short-term outcome of AC- and naturally conceived preterm infants <32 weeks gestation., Methods: The area-based cohort study ACTION collected data on births 22-31 weeks gestation occurred in 2003-05 in 6 Italian regions. Infants born to 2529 mothers with known mode of conception were studied. The main outcomes were hospital mortality and survival free from major morbidities (IVH grade 3-4, cPVL, ROP stage ≥3, BPD), and were assessed separately for single and multiple infants. Other outcomes were also investigated. Multivariable logistic analyses were used to adjust for maternal and infants' characteristics. To account for the correlation of observations within intensive care units, robust variance and standard error estimates of regression parameters were computed., Results: AC was used in 6.4% of mothers. Infants were 2934; 314 (10.7%) were born after AC. Multiples were 86.0% among AC and 21.7% among non-AC babies. In multivariable analysis no statistically significant difference in hospital mortality and survival without major morbidities was found between AC and non-AC infants. The risk of BPD was lower in AC than in non-AC multiples (aOR 0.41, CI 0.20-0.87), and this finding did not change after controlling for mechanical ventilation (aOR 0.42, CI 0.20-0.85) or presence of a patent ductus arteriosus (aOR 0.39, CI 0.18-0.84)., Conclusion: When the analysis is restricted to very preterm infants and stratified by multiplicity, no significant associations between AC and increased risk of short-term mortality and survival without major morbidities emerge. This result is consistent with previous studies, and may confirm the hypothesis that the adverse effects of AC are mediated by preterm birth. However, larger appropriately powered studies are needed before definitely excluding the possibility of adverse events linked to AC in infants born before 32 weeks gestation.

Background: Although very preterm infants are recommended to receive immunizations, according to their chronological age, immunization start in these infants is often delayed. Aim To measure coverage and timeliness of routine immunizations in Italian very preterm infants and to assess determinants of delay., Methods: We followed up infants 22-31 completed weeks of gestational age discharged from intensive care. We measured the proportion of children with one dose of diphtheria-tetanus-pertussis-poliohepatitis, B-Hib vaccine (DTP-Pol-HBV-Hib), measles-mumps-rubella vaccine (MMR), conjugate pneumococcal vaccine (Pnc), conjugate meningococcal C vaccine (MenC), and varicella vaccine (Var) by 24 months. We used the Kaplan Meier method and Cox proportional hazard models to estimate the age, at immunization start and determinants of timeliness for each vaccine., Results: Data on 1102 (92.1%) children out of 1196 included in the cohort were analyzed. Immunization start by 24 months of age occurred in 95.9% of children for DTP-Pol-HBV-Hib; 84.0% for MMR; 49.7% for Pnc; 38.5% for MenC; and 4.1% for Var. Eighty-seven percent of participants received the first dose of DTP-Pol-HBV-Hib by 6 months of age, and 66.7% had their first MMR administered by 18 months. Hospitalization was associated with delay for all vaccines with the exception of MenC and Var. Maternal employment was associated with earlier immunization for MMR, Pnc, and MenC. DTP-Pol-HBV-Hib timeliness improved with increasing birthweight and paternal employment and decreased with a larger number of siblings in the household. MMR was delayed in children with cerebral palsy, and in those with a larger number of children in the household. Immunization for Pnc was delayed in children with larger number of siblings., Conclusions: Immunization start for all vaccines was considerably delayed in many very preterm infants. Public health strategies taking into account determinants of delay should be implemented to improve coverage and timeliness of vaccination in this group of infants., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

This study aimed at exploring the relationship between severe neuromotor and/or sensory disability in very preterm infants assessed at 2 years corrected age and their mothers' psychological health. Data on 581 Italian singletons born at 22-31 weeks of gestation in five Italian regions and their mothers were analyzed. Maternal psychological distress was measured through the General Health Questionnaire short version (GHQ-12). The prevalence of any maternal distress (GHQ scores ≥ 2) and of clinical distress (scores ≥ 5) were 31.3% and 8.1% respectively. At multivariable analysis, we found a statistically significant association between child's disability and mothers' GHQ scoring ≥ 5 (OR 3.45, 95% CI 1.07-11.15). Also lower maternal education appeared to increase the likelihood of psychological distress (OR 1.38, 95% CI 1.14-1.66). The impact of child disability was weaker in women who had experienced additional stressful life events since delivery, pointing to the existence of a "ceiling" effect. Maternal psychological assessment and support should be included in follow-up programs targeting very preterm infants., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Background: We examined the relationships between -pregnancy disorders leading to very preterm birth -(spontaneous preterm labor, prelabor premature rupture of -membranes (PPROM), hypertension/preeclampsia, -intrauterine growth restriction (IUGR), antenatal hemorrhage, and maternal -infection), both in isolation and grouped together as -"disorders of placentation" (hypertensive disorders and IUGR) vs. -"presumed infection/inflammation" (all the others), and several unfavorable neonatal outcomes., Methods: We examined a population-based prospective cohort of 2,085 singleton infants of 23-31 wk gestational age (GA) born in six Italian regions (the Accesso alle Cure e Terapie Intensive Ostetriche e Neonatali (ACTION) study)., Results: Neonates born following disorders of placentation had a higher GA and better overall outcomes than those born following infection/inflammation. After adjustment for GA, however, they showed higher risk of mortality (odds ratio, OR: 1.4; 95% confidence interval, CI: 1.0-2.0), bronchopulmonary dysplasia (BPD) (OR: 2.5; CI: 1.8-3.6), and retinopathy of prematurity (ROP) (OR: 2.0; CI: 1.1-3.5), especially in growth-restricted infants, and a lower risk of intraventricular hemorrhage (IVH) (OR: 0.5; CI: 0.3-0.8) and periventricular leukomalacia (PVL) (OR: 0.6; CI: 0.4-1.1) as compared with infants born following -infection/inflammation disorders., Conclusion: Our data confirm the hypothesis that, in very preterm infants, adverse outcomes are both a function of immaturity (low GA) and of complications leading to preterm birth. The profile of risk is different in different pregnancy disorders.

Objective: To assess the relationship between antenatal factors and cause-specific risk of death in a large area-based cohort of very preterm infants., Study Design: The ACTION (Accesso alle Cure e Terapie Intensive Ostetriche e Neonatali) study recruited during an 18-month period all infants 22-31 weeks' gestational age admitted to neonatal care in 6 Italian regions (n=3040). We analyzed the data of 2974 babies without lethal or acutely life-threatening malformations. Cause-specific risks of death adjusted for competing causes were calculated, and region-stratified multiple Cox regression analyses were used to study the association between cause-specific mortality and infants' characteristics, pregnancy complications, antenatal steroids, and place of birth., Results: Deaths attributable to respiratory problems and intraventricular hemorrhage prevailed in the first 2 weeks of life, and those attributable to infections and gastrointestinal diseases afterwards. Antepartum hemorrhage was associated with respiratory deaths (hazard ratio [HR] 1.6, 95% CI 1.1-2.4), and maternal infection with deaths attributable to asphyxia (HR 32.5, 95% CI 4.1-259.4) and to respiratory problems (HR 2.8, 95% CI 1.6-5.2). Preterm premature rupture of membranes increased the likelihood of deaths due to neonatal infection (HR 1.8, 95% CI 1.0-3.1), and preterm labor/contractions of those due to respiratory (HR 1.5, 95% CI 1.1-2.0) and gastrointestinal diseases (HR 5.8, 95% CI 2.1-16.3). In addition, a birth weight z-score<-1 was associated with increasing hazards of death resulting from asphyxia, late infections, respiratory, and gastrointestinal diseases., Conclusions: Different complications of pregnancy lead to different cause-specific mortality patterns in very preterm infants., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Purpose: To study the association between congenital heart diseases (CHD) and in-hospital mortality and morbidity of very preterm/very low birth weight (VLBW) infants., Methods: The area-based prospective cohort study ACTION included all infants with gestational age (GA) 22-31 weeks or birth weight <1,500 g admitted to neonatal care between July 2003 and June 2005 in six Italian regions (n = 3,684). CHD were coded according to ICD9-CM. Cluster multivariable logistic regression analyses were used to assess the relationship between CHD and mortality and selected morbidities [neonatal infection, ultrasound brain abnormalities, retinopathy of prematurity (ROP), and bronchopulmonary dysplasia (BPD)] adjusting for potential confounders., Results: Seventy-one patients had CHD [19.3 ‰, 95 % confidence interval (CI) 15.1-24.2 ‰]. The most common lesions were isolated atrial and ventricular septal defects (31.1 and 26.8 %, respectively), pulmonary valvar stenosis (12.7 %), and tetralogy of Fallot (5.6 %). Compared with other infants, CHD patients showed significantly higher GA and frequency of small for gestational age (SGA, i.e., birth weight ≤3rd centile). After adjustment for GA, sex, SGA, presence of extracardiac malformations or chromosomal anomalies, and region of birth, CHD patients had a significantly higher likelihood of infection, BPD, ROP, and, after 27 weeks gestation only, hospital mortality. The increased risk of ROP appeared to be partly due to infection., Conclusions: In very preterm/VLBW infants CHD are more prevalent than in the general liveborn population, and confer an increased risk of death and serious morbidities independently of other risk factors. These results may be useful to better tailor prognostic assessment and diagnostic and therapeutic interventions for these children.

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.

Objectives: To investigate the relationships between mortality of infants <32 weeks gestation and neonatal intensive care units' (NICUs) volume of activity, daily number of high-dependent infants (HDIs) and geographical area in Italy., Methods: The study involved 105 neonatal units in 2005. Data were collected prospectically and through monthly cross-sectional investigations. Patients receiving respiratory care were defined as HDIs. Univariate and multivariable methods were used for analysis., Results: Babies enrolled were 4014. The overall mortality was 18.8%. An adjusted nearly two-fold increase in mortality was found in Southern compared to Northern regions. Volume of activity was not associated with mortality. When compared to infants admitted to NICUs in the highest tertile of the median number of HDIs/day (>2.5 patients/day), the adjusted odds ratios were 1.52 (95% CI = 1.14-2.02) for those in the 2nd tertile (1.1-2.5 patients/day) and 1.47 (95% CI = 1.02-2.13) for those in the lowest tertile (≤1 patient/day). After stratification by geographical area, this relationship was present in Southern, to a lesser extent in Central, but not in Northern regions., Conclusions: In Italy, striking geographical differences in mortality of very preterm infants are present. NICUs' average daily number of HDIs is a better predictor of mortality than the volume of activity.

Objective: To investigate the accuracy of procalcitonin (PCT) as a diagnostic marker of nosocomial sepsis (NS) and define the most accurate cut-off to distinguish infected from uninfected neonates., Setting: Six neonatal intensive care units (NICUs)., Patients: 762 neonates admitted to six NICUs during a 28-month observational study for whom at least one serum sample was taken on admission., Main Outcome Measures: Positive and negative predictive values at different PCT cut-off levels., Results: The overall probability of an NS was doubled or more if PCT was >0.5 ng/ml. In very-low-birth-weight (VLBW) infants, a cut-off of >2.4 ng/ml gave a positive predictive value of NS near to 50% with a probability of a false-positive diagnosis of NS in about 10% of the patients., Conclusions: In VLBW neonates, a serum PCT value >2.4 ng/ml prompts early empirical antibiotic therapy, while in normal-birth-weight infants, a PCT value ≤2.4 ng/ml carries a low risk of missing an NS.

Background/purpose: The increased survival rate reached in infants with congenital diaphragmatic hernia (CDH) has shown a concomitant increase in late morbidity. A recent report from CDH Study Group showed that dimension of diaphragmatic defect is the only independent risk factor of mortality. However, the influence of defect size on late morbidity is still controversial. The aim of the study was to evaluate the influence of patch repair (proxy of diaphragmatic defects size) on midterm morbidity., Methods: All high-risk (prenatal diagnosis and/or respiratory symptoms within 6 hours of life) CDH survivors treated at our institution from 2004 to 2008 were followed up in a multidisciplinary outpatient clinic as part of a longitudinal prospective study. Auxological, gastroesophageal, pulmonary, and orthopedic evaluations were performed at 6, 12, and 24 months of age. Patient outcomes were compared with respect to +/- patch repair., Results: Of 70 survivors, 61 (87%) were enrolled and prospectively evaluated in follow-up. Poorer auxological outcome, increased rate of gastroesophageal reflux, and altered pulmonary function test were observed during follow-up., Conclusions: Patch repair correlates with higher pulmonary, auxological, and gastroesophageal morbidity without increasing chest wall deformities at long-term follow-up., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: Nosocomial infections are still a major cause of morbidity and mortality among neonates admitted to neonatal intensive care units (NICUs)., Objective: To describe the epidemiology of nosocomial infections in NICUs and to assess the risk of nosocomial infection related to the therapeutic procedures performed and to the clinical characteristics of the neonates at birth and at admission to the NICU, taking into account the time between the exposure and the onset of infection., Design: A multicenter, prospective cohort study., Patients and Setting: A total of 1,692 neonates admitted to 6 NICUs in Italy were observed and monitored for the development of nosocomial infection during their hospital stay., Methods: Data were collected on the clinical characteristics of the neonates admitted to the NICUs, their therapeutic interventions and treatments, their infections, and their mortality rate. The cumulative probability of having at least 1 infection and the cumulative probability of having at least 1 infection or dying were estimated. The hazard ratio (HR) for the first infection and the HR for the first infection or death were also estimated., Results: A total of 255 episodes of nosocomial infection were diagnosed in 217 neonates, yielding an incidence density of 6.9 episodes per 1,000 patient-days. The risk factors related to nosocomial infection in very-low-birth-weight neonates were receipt of continuous positive airway pressure (HR, 3.8 [95% confidence interval {CI}, 1.7-8.1]), a Clinical Risk Index for Babies score of 4 or greater (HR, 2.2 [95% CI, 1.4-3.4]), and a gestational age of less than 28 weeks (HR, 2.1 [95% CI, 1.2-3.8]). Among heavier neonates, the risk factors for nosocomial infection were receipt of parenteral nutrition (HR, 8.1 [95% CI, 3.2-20.5]) and presence of malformations (HR, 2.3 [95% CI, 1.5-3.5])., Conclusions: Patterns of risk factors for nosocomial infection differ between very-low-birth-weight neonates and heavier neonates. Therapeutic procedures appear to be strong determinants of nosocomial infection in both groups of neonates, after controlling for clinical characteristics.

In infants with necrotizing enterocolitis (NEC), intestinal gangrene defines advanced disease. Since intestinal ischemia is considered a pathogenetic factor for intestinal gangrene, serum activity of mucosal and seromuscular enzymes may be elevated in these patients. Our aim was to evaluate if serum enzymes activity is increased in infants with NEC associated with intestinal gangrene. We performed a retrospective review of the case notes of infants operated on for NEC between 1998 and 2006. Patients with preoperative determination of serum enzymes were included in the study, and were divided into Group A and Group B based on the presence or absence of intestinal gangrene, respectively. Serum activities of alkaline phosphatase (ALP), glutamic oxaloacetic transaminase (GOT), creatine kinase (CK), and lactate dehydrogenase (LDH) were compared in the two Groups. Values are medians (interquartile range). Thirty-five infants were operated on for NEC in the study period. Eighteen patients fulfilled the inclusion criteria: 12 in Group A and six in Group B. Group A patients had significantly higher LDH activity [1131.0 (1092.0-1300.0) vs. 482.0 (440.0-624.5) IU/L; P < 0.005]. Our findings suggest that LDH activity may be increased in infants with NEC and intestinal gangrene. Its evaluation could be a further tool in the surgical decision making process in infants with NEC.

Aim of the Study: Infants with congenital diaphragmatic hernia (CDH) are at high risk of sensorineural hearing loss (SNHL). Extracorporeal membrane oxygenation is known to increase this risk, but little is known about other potential causes. We evaluated the impact of several risk factors on SNHL development in CDH survivors not treated with extracorporeal membrane oxygenation., Methods: All high-risk CDH survivors consecutively treated between 1999 and 2005 were included. SNHL was diagnosed based on formal assessment with standard audiologic tests. Patients with and without SNHL were compared for patient-related and treatment-related risk factors. Subsequently, a logistic regression analysis was performed to identify independent risk factors associated with SNHL development., Main Results: Out of 87 CDH survivors, 82 had a formal audiologic evaluation and 40 (49%) had SNHL. Patients with SNHL had significantly lower gestational age (P = .045); higher prevalence of sepsis (P < .001); older age at audiologic examination (P < .001); more episodes of hypocapnia (P = .045); higher prevalence of inhaled nitric oxide use (P = .005); longer mechanical ventilation (P = .009); and longer aminoglycosides (P = .006), furosemide (P = .004), and pancuronium bromide (P = .001) treatments. On logistic regression analysis, the only variable independently associated with the development of SNHL was patient's age at audiologic follow-up (P = .012)., Conclusions: Several risk factors were associated with SNHL development at univariate analysis. After logistic regression, only age at evaluation remained independently associated with SNHL. Routine audiologic follow-up is advocated in all CDH patients. Further studies are needed to define if other (genetic) factors may be involved in the pathogenesis of SNHL in patients with CDH.

In a newborn with severe respiratory failure and abnormal elevation of the right diaphragm, congenital diaphragmatic hernia with sac was diagnosed during surgery. However, microscopic examination of the sac showed atrophic striated muscle cells, indicating eventration instead of hernia. After several extubation failures, the final diagnosis of nemaline myopathy was made by skeletal muscle biopsy. In diaphragmatic defects with sac, diaphragm microscopic analysis should be recommended in order to discriminate between hernia and eventration. Congenital myopathies may underlie such diaphragmatic defects and should be promptly recognized, given their prognostic implications.

Unlabelled: The assessment of lung volumes, particularly functional residual capacity (FRC), is crucial for understanding lung development during infancy in CDH patients., Aim: To evaluate changes in lung function during infancy in subjects with CDH treated with a "gentle ventilation" technique and delayed surgery strategy in the neonatal period., Methods: 13 CDH infants were studied twice and compared with a population of 28 healthy infants (HI). Tidal-Volume (Vt), respiratory rate (RR) and time to peak expiratory flow/expiratory time ratio (tPTEF/Te) were measured with an ultrasonic flow meter; Compliance (Crs) and Resistance (Rrs) of the respiratory system were studied with the single occlusion technique; FRC and Lung Clearance Index (LCI), were assessed with the sulfur hexafluoride (SF6) wash-in/wash-out technique. The differences between the first (T1) and second (T2) measurement in the CDH group were assessed by the Student's t-test for paired values. For each set of measurement (T1 and T2) the values were compared with HI by Student's t-test., Results: Mean age at test was 7.5 +/- 5.2 months for HI, 4.5 +/- 2.5 at T1 and 11.9 +/- 4.5 months at T2 for CDH infants. At T1 there were no significant differences between CDH infants and HI in Vt, Crs, and FRC, while tPTEF/te ratio was lower and RR, Rrs, and LCI were higher in CDH patients than in HI. At T2 Vt, Crs, and FRC remained normal in CDH patients as well as RR that, at this time was not different between CDH and healthy infants; tPTEF/te remained below and Rrs and LCI remained above normal ranges, indicating a persistent impairment in lower airways patency., Conclusions: Lung function in infants with severe CDH is characterized by a persistent impairment in airways patency and significant inhomogeneity of ventilation, suggesting a peripheral bronchial obstruction even if the other lung function tests are within normal ranges.

Aim: A number of social and health aspects in Italy show remarkable geographic dishomogeneity. We investigated if this phenomenon involves the outcome of very low birth-weight infants (VLBWI)., Methods: This is a multi-centre nation-based survey among all Italian NICUs. The number of VLBWI admitted to each NICU in 2001 by birth-weight classes of 250 g, their inborn/outborn status and survival at discharge were registered through ad hoc questionnaires. The data were analysed for the whole country and for three geographic areas (North, Centre and South)., Results: A total of 4679 VLBWI in 125 units were surveyed (0.88% of live births in Italy in 2001). The median number of infants admitted was 34 per NICU (interquartile range 16,52), without significant differences among the three geographic areas. The inborn rate was 80.7% (86.5% in the North, 83.7% in the Centre and 74.6% in the South). The mortality rate was 19.6% (15.6% in the North, 19.3% in the Centre and 23.4% in the South). Adjusted relative risk of death between Southern and Northern regions was 1.48 (95% CI 1.30-1.68), and that between outborn and inborn infants was 1.20 (95% CI 1.04-1.37)., Conclusions: The differences in mortality among geographic areas suggest a state of socio-sanitary deprivation in the Southern regions, as well as different models of organisation and quality of perinatal care.

Background: Despite improvements in clinical management, mortality of congenital diaphragmatic hernia (CDH) remains high. Early prediction of mortality risk helps in comparing strategies and/or performances of different centers. Birth weight (BW), Apgar Score at 5 minutes, and modified McGoon Index (MGI) calculated by the ratio between the diameters of pulmonary arteries and the descending aorta have been used to determine mortality of CDH., Aim: The purpose of this study is to evaluate the relationship between early detectable variables and survival in newborns with CDH intubated at birth, managed with "gentle" ventilation and delayed surgery., Methods: All medical records of patients affected by high-risk CDH and treated with a standardized protocol at Bambino Gesù Children's Hospital, Rome, Italy, between January 2002 and September 2004 were reviewed. Prenatal diagnosis, gestational age, BW, sex, side of hernia, and MGI were recorded on admission. The relationship with mortality of each variable was evaluated by univariate analysis. Subsequently, a predictive model of mortality was developed using a logistic regression: the explanatory variables, BW, and MGI were dichotomized in high (HBW and HMGI) and low (LBW and LMGI) according to the best cutoff found with receiver-operating characteristic curves., Results: Thirty-four newborns with CDH, treated with a standardized protocol, were studied. The main characteristics of the 34 patients were BW, 2886 g (1500-3620 g); gestational age, 37.7 weeks (32-42 weeks); male/female, 22/12; right/left, 8/26; prenatal diagnosis, 29; MGI, 1.31 (0.9-1.85). Only BW and MGI were significantly (P < .05) associated with mortality at the univariate analysis. The best cutoff values were 2755 g for BW (sensitivity, 70%; specificity, 74%) and 1.25 for MGI (sensitivity, 73%; specificity, 78%). Using these limits, BW and MGI resulted independently associated with mortality in the multivariate analysis. Using the 4 possible combinations, the LBW associated with the LMGI presented the highest prediction of mortality (80%)., Conclusions: Birth weight and MGI, variously combined, were predictive of mortality. Because they are not influenced by subsequent modalities of care, they can be considered as valid early severity scores in CDH and used for comparing strategies and/or performances of different centers.

Background: Cardiorespiratory stabilization is recommended before surgical repair of congenital diaphragmatic hernia (CDH) because surgery may induce a transitory deterioration of chest compliance and gas exchange. It is not known if surgical intervention can affect cerebral circulation and oxygenation., Aim: The aim of the study was to assess noninvasively, by near-infrared spectroscopy, the possible changes in cerebral hemodynamics and oxygenation associated with surgical repair of CDH., Subjects: Twenty-five newborns with severe CDH (birth weight, 3057 +/- 354 g; gestational age, 37.8 +/- 1.8 weeks; male/female newborns, 15/10; left/right CDH, 19/6) were sedated, paralyzed, and mechanically ventilated by conventional gentle ventilation and surgically corrected at a median age of 2.7 days (min-max, 2-14 days) after cardiorespiratory stabilization., Methods: Heart rate (HR [beats per minute]), preductal transcutaneous oxygen saturation (tcSaO2 [%]), carbon dioxide tension (tcPCO2 [Torr]), and mean arterial blood pressure (mm Hg) were continuously monitored. Inspired fractional oxygen concentration (FIO2) was adjusted to maintain and preductal tcSaO2 of greater than 80%, whereas the ventilator's settings were kept unchanged throughout the surgical procedure. Cerebral hemodynamics was assessed by near-infrared spectroscopy (NIRO 300, Hamamatsu Photonics, Japan), recording continuously and noninvasively the relative changes in concentration of oxygenated (DeltaO2Hb [micromol/L]), deoxygenated (DeltaHHb [micromol/L]), and total (DeltatHb [micromol/L]) hemoglobin; the tissue oxygenation index (TOI [%]) was also calculated (TOI = O2Hb/O2Hb + HHb). Total hemoglobin concentration is considered to be representative of cerebral blood volume. Arterial blood gases were also measured at the beginning (T1) and at the end of surgery (T2). For all measurements, results at T1 and at T2, as well as the differences between T1 and T2, have been expressed as means or medians and SDs or 95% confidence intervals or ranges. The differences between T1 and T2 were considered statistically significant for a P value of less than .05 by the Student t test for paired values., Results: At T1, mean tcSaO2% was 94.1 % (SD, 4.6) with a FIO2 of 0.25 (SD, 0.1); at T2, to obtain similar values of tcSaO2 (93.4%; SD, 4.4), it was necessary to increase the FIO2 to 0.37 (SD, 0.14; P < .001). Mean HR at T1 was 149.5 beats per minute (SD, 9.1) and increased significantly (P < .05) at T2 (165.2 beats per minute; SD, 14.2). Mean arterial blood pressure was 54.7 mm Hg (SD, 7.7) at T1 and did not change appreciably at T2 (55.6 mm Hg; SD, 8.1). Moreover, tcPCO2 did not change significantly during the procedure (mean tcPCO2 = 49.9 Torr [SD, 12.8] at T1 and 57.3 mm Hg [SD, 17.9] at T2). O2Hb and tHb decreased (P < .001 and <.005) and HHb increased (P < .05) significantly during the surgical procedure (mean Delta [SD]: DeltaO2Hb= -10.9 micromol/L [9.7], DeltatHb = -7.5 micromol/L [11.7], and DeltaHHb = -3.5 micromol/L [6.8]). Mean TOI was 70% at T1 (normal values >60%) and decreased significantly at T2 (mean DeltaTOI = -6.1% [SD, 10.6]). In all infants, the greatest changes occurred when the viscera were positioned into the abdomen., Conclusions: Notwithstanding the initial cardiorespiratory stabilization, surgical repair of CDH was associated with a rise in HR and oxygen requirement and a drop in cerebral tHb and O2Hb, suggesting a reduction in cerebral blood volume and oxygenation. These events were probably due to the combined effects of an increase in right to left shunting (as indicated by the increased oxygen requirement) and a decrease in venous return (possibly due to compression of the inferior vena cava by the viscera positioned into the abdomen). These preliminary results reinforce the importance of achieving a good cardiorespiratory stability before undertaking surgical correction of CDH to minimize the possible interference of the procedure with cerebral circulation and oxygenation.

Objective: The aim of this study was to improve the definition of birth weight discordancy based on its distribution in the population after a correction in the unlike sex pairs., Study Design: The analysis was conducted on 849 Italian twin pairs. Male's birth weight in the unlike sex pairs was corrected by the physiological birth weight difference estimated on 21.595 Italian twins data. Birth weight discordancy was computed as a percentage of the larger twin's birth weight and it was compared by sex pairs and by gestational ages (Kruskal-Wallis test). Kolmogorov-Smirnov test was used to fit a normal distribution to the square-root transformed birth weight discordancy., Results: The estimated physiological birth weight difference between males and females was 4.39%, without any difference among gestational ages. The 90th centile of birth weight discordancy was 23.9% and the 95th centile was 29.2%., Conclusions: Ninetieth and 95th centiles of the fitted distribution are proposed as cut-off values for the definition of mild and severe birth weight discordancy.

The association between history of asthma in the mother and low birth weight (< 2,500 g) was studied in 2,929 primary schoolchildren, randomly selected from three areas of the Lazio Region, Italy, and enrolled in a cross-sectional survey to assess their health status in relation to environmental factors. A history of asthma in the mother was associated with a higher prevalence of low birth weight, with a crude OR of 2.95 (95% CI 1.10-6.72). After stratification for other variables, an association was still present only for males (OR 4.13; 95% CI 1.01-12.53), when mothers had smoked in pregnancy (OR 8.02; 95% CI 1.63-32.28) and were resident in an industrial town (OR 10.21; 95% CI 2.69-32.27). An OR of 6.43 was also found when mothers belonged to low social class, but the 95% CI included the unity. These results suggest that a history of asthma in the mother is a risk factor for low birth weight, but only when other adverse factors are concurrently present.

The purpose of this study was to find out possible differences in prenatal diagnosis (PD) by amniocentesis or chorionic villus sampling and ultrasound examination before 16 weeks' gestation (early ultrasound examination, EUE), according to area of residence and level of education of the mothers. Data come from a multicentre study in Italy involving 43 maternity hospitals (Mercurio project) and were collected through structured interviews a few days after delivery. Study subjects were 1541 mothers of single non-malformed infants born between April 1992 and March 1994. Overall, the incidence of PD and EUE was 5.8 and 80 per cent, respectively. After adjustment for maternal age and other possible confounders, the odds ratios for PD were 2.19 (95 per cent confidence interval (CI) = 1.26-3.81) when women residing in the northern regions were compared with those residing in the southern regions, and 2.06 (95 per cent CI = 1.12-3.79) and 4.08 (95 per cent CI = 1.97-8.42) when women with medium and high levels of education were compared with those with low level. For EUE, the odds ratios were 1.77 (95 per cent CI = 1.32-2.36) and 2.88 (95 per cent CI = 1.56-5.29) when comparing women with medium and high levels of education with those with low level. No relationship was found between area of residence and EUE. These geographical and social inequalities in prenatal care in Italy should be taken into account for the organization, delivery, and evaluation of pregnancy services in the coming years.

A cohort of 917 Down syndrome (DS) children born in Italy between 1978 and 1984 was studied for survival through the age of 8 years. The highest mortality occurred in the first month of life (7.9%); survival was about 80% at 1 year, 78% at 2 years, and 76% at 5 years, with small decreases thereafter. At the univariate analysis, survival was lower for subjects with congenital heart disease (CHD), birth weight less than 2,500 g, parity of 3 or plus, maternal age greater than or equal to 35 years, and for those born in Southern Italy compared with Northern Italy. No differences in survival were observed by sex and by socioeconomic status. The Cox proportional hazard model was used to evaluate the effect of each variable adjusted for all the others present in the model. Presence of CHD (odds ratio = 3.27; 95% confidence interval (C.I.) 2.31-4.63), birth in the South (odds ratio = 2.69; 95% C.I. 1.91-3.79), and low birth weight (odds ratio = 1.87; 95% C.I. 1.29-2.72) were independently associated with survival. None of the other variables emerged as a statistically significant prognostic factor. Various hypotheses were considered to interpret the unexpected effect of place of birth on survival. Quality of medical care provided in the South of Italy is the most likely determinant of the high mortality observed among children with DS born in that area of Italy. Such differences in survival within the same country could occur in other developed nations as well.

The Italian Multicenter Study on Very Low Birth Weight babies (IMS-VLBW) is the first collaborative investigation performed in Italy on the health status of newborns weighing less than 1500 g at birth. Eight Neonatal Intensive Care Units (NICUs) participated in the study: Cagliari, Napoli, Padova, Palermo, Roma, Sassari, Trieste, Udine. Data were analyzed in the Laboratorio di Epidemiologia e Biostatistica of the Istituto Superiore di Sanità. The objectives of the study were established in the following: a) to collect accurate descriptive data on neonatal morbidity, mortality and long term outcome of VLBW babies admitted to NICUs; b) to analyze the risk factors of unfavourable outcome (death or handicap) and to analyze, with respect to outcome, the relationships between risk factors, neonatal diseases and therapeutical procedures; c) to test the feasibility of a multicenter follow-up programme based on the use in all participating Centers of the same diagnostic criteria (the results of follow-up will be presented in a forthcoming paper). In the years 1987 and 1988, 634 newborns weighing 500-1499 g at birth were enrolled in the study. In-hospital mortality for the whole group was 33.1% (65.1% in the 500-999 g birth weight class and 19.2% in the 1000-1499 g class). Mortality was not different for inborn vs outborn babies. A high incidence of unfavourable perinatal conditions was observed in these babies, namely birth asphyxia, sub-optimal care during transport, poor clinical conditions on arrival to the NICU. Neonatal diseases, like respiratory distress syndrome and peri-intra ventricular hemorrhage were also frequent and severe. A logistic regression analysis of pre-admission risk factors of in-hospital death identified eight statistically significant variables: birth weight; gestational age; sex; antenatal steroid stimulation of lung maturity; first minute Apgar score; absence of spontaneous respiration, body temperature and pH on arrival to the NICU. Using the equation derived from the logistic regression analysis a theoretical mortality rate, predicted on the basis of the local incidence of pre-admission risk factors, was calculated for each Center. In no case the predicted mortality was statistically different from the observed one, suggesting that in our study differences in observed mortality rates from one Center to another are largely influenced by pre-admission risk factors.