Marcello Orzalesi

Parental visiting, communication, and participation in ethical decisions: a comparison of neonatal unit policies in Europe.

AIM To compare neonatal intensive care unit policies towards parents’ visiting, information, and participation in ethical decisions across eight European countries. METHODS One hundred and twenty three units, selected by random or exhaustive sampling, were recruited, with an overall response rate of 87%. RESULTS Proportions of units allowing unrestricted parental visiting ranged from 11% in Spain to 100% in Great Britain, Luxembourg and Sweden, and those explicitly involving parents in decisions from 19% in Italy to 89% in Great Britain. Policies concerning information also varied. CONCLUSIONS These variations cannot be explained by differences in unit characteristics, such as level, size, and availability of resources. As the importance of parental participation in the care of their babies is increasingly being recognised, these findings have implications for neonatal intensive care organisation and policy.

Prophylactic nasal continuous positive airways pressure in newborns of 28–31 weeks gestation: multicentre randomised controlled clinical trial

Background: The role of nasal continuous positive airways pressure (nCPAP) in the management of respiratory distress syndrome in preterm infants is not completely defined. Objective: To evaluate the benefits and risks of prophylactic nCPAP in infants of 28–31 weeks gestation. Design: Multicentre randomised controlled clinical trial. Setting: Seventeen Italian neonatal intensive care units. Patients: A total of 230 newborns of 28–31 weeks gestation, not intubated in the delivery room and without major malformations, were randomly assigned to prophylactic or rescue nCPAP. Interventions: Prophylactic nCPAP was started within 30 minutes of birth, irrespective of oxygen requirement and clinical status. Rescue nCPAP was started when Fio2 requirement was > 0.4, for more than 30 minutes, to maintain transcutaneous oxygen saturation between 93% and 96%. Exogenous surfactant was given when Fio2 requirement was > 0.4 in nCPAP in the presence of radiological signs of respiratory distress syndrome. Main outcome measures: Primary end point: need for exogenous surfactant. Secondary end points: need for mechanical ventilation and incidence of air leaks. Results: Surfactant was needed by 22.6% in the prophylaxis group and 21.7% in the rescue group. Mechanical ventilation was required by 12.2% in both the prophylaxis and rescue group. The incidence of air leaks was 2.6% in both groups. More than 80% of both groups had received prenatal steroids. Conclusions: In newborns of 28–31 weeks gestation, there is no greater benefit in giving prophylactic nCPAP than in starting nCPAP when the oxygen requirement increases to a Fio2 > 0.4.

Neonatal seizures: characteristics of EEG ictal activity in preterm and fullterm infants

The neonatal EEG remains one of oldest, yet most valuable, diagnostic and prognostic tests in neonates. The goals of this study were to determine the relationships between the morphology, frequency, and distribution of ictal discharges in the neonatal EEG with age, EEG background activity, and etiology. A total of 156 ictal events were evaluated in 11 preterm (PT) and 25 fullterm (FT) infants. Most of the infants had severe abnormalities of background activity although ictal discharges occurred on both normal and abnormal backgrounds. There was a trend for a closer relationship between behavioral changes during the electroencephalographic seizure when the background activity was normal or moderately abnormal than when background activity was severely abnormal. In both PT and FT infants, the most common site of seizure origin was the temporal lobe. FT infants commonly had sharp waves, spikes, sharp and slow waves, and spike and slow waves at the onset of the ictus while rhythmic delta activity was most common in the PT infants. PT infants typically had a regional onset to the ictus whereas FT infants most frequently had a focal onset. Duration of the ictal events was similar in PT and FT infants and a change in morphology or frequency of the discharges was common during propagation of the ictal discharges in both age groups. There was not a clear relationship between onset, morphology, frequency, or propagation patterns and etiology in either the PT or FT infants. Our results demonstrate that while the type of ictal discharge is related to gestational age, there is a rich variety in the onset, morphology, and frequency of the ictal discharges in both PT and FT infants and that neonatal ictal patterns lack a close correlation with underlying pathology.

Low Serum Levels of Mannose Binding Lectin Are a Risk Factor for Neonatal Sepsis

Mannose binding lectin (MBL) is a soluble pattern recognition receptor of innate immunity that binds a wide range of pathogens and exerts opsonic effects. We investigated the association between serum MBL levels and development of sepsis in infants admitted to neonatal intensive care units (NICUs). Serum MBL levels on admission were measured by enzyme-linked immunosorbent assay (ELISA) in 206 neonates consecutively admitted to an NICU of whom 138 did not develop hospital-acquired sepsis and 68 did. Of these 68, 40 had confirmed sepsis with positive blood cultures, 19 clinically suspected sepsis, with negative blood cultures, and nine had clinically suspected sepsis with blood culture yielding coagulase-negative staphylococci (CoNS). Serum MBL levels on admission were significantly lower in infants with sepsis [0.45 μg/mL; interquartile range (IQR) 0.09–1.68], particularly in those with confirmed sepsis (0.17 μg/mL; IQR 0.05–0.96), compared with infants without sepsis (1.45 μg/mL; IQR 0.43–3.52), and infants with CoNS-positive blood culture (1.70 μg/mL: IQR 0.85–3.60). After adjusting for duration of exposure gestational age (GA) and birth weight (BW), the association of low MBL levels with development of sepsis was maintained [odds ratio (OR) = 0.52; 95% confidence interval (CI): 0.36–0.75]. The measurement of serum MBL levels on admission in NICU may help to identify neonates at higher risk of developing sepsis.

Determinants of Nosocomial Infection in 6 Neonatal Intensive Care Units: An Italian Multicenter Prospective Cohort Study

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.

Role of mannose-binding lectin in nosocomial sepsis in critically ill neonates.

We investigated the association of mannose-binding lectin (MBL) serum levels with nosocomial sepsis (NS), their changes overtime during infection, their relation with pathogens, with the MBL2 genotype and their relationship with mortality. In a prospective observational study, we included 365 critically ill neonates: 261 had no infection and 104 had at least 1 septic event. The median MBL serum concentration was significantly lower in infected than in noninfected neonates (p < 0.001). Low MBL levels on admission increased the risk of infection, independently from gestational age and invasive procedures. The median peak MBL level during infection was higher than the median level on admission (p < 0.001) and was correlated with it (r(2) = 0.83, p < 0.001). Moreover, MBL levels on admission were not associated with death (OR = 0.80, 95% CI = 0.56-1.14, p = 0.21). Similarly, no association was found between MBL peak levels during infection and death among infected neonates (OR = 1.10, 95% CI = 0.78-1.57, p = 0.57). In 127 neonates (42 infected) genotyped for exon-1 and -221 promoter MBL2 variants, we did not find significant difference in the frequencies of MBL2 genotypes between infected and noninfected neonates. Moreover, no association was found between MBL2 genotypes and death.

Pulmonary function in children withpectus excavatum

Lung volumes, maximal breathing capacity, and timed vital capacity were measured in 12 children with severe pectus excavatum. The mean values for vital capacity, total lung capacity, and maximal breathing capacity for this group of patients were significantly lower than predicted, while the residual volumes, functional residual capacities, and timed vital capacities were within normal limits. The values obtained indicated that only 3 patients had an abnormally low vital capacity and only one a low maximal breathing capacity. In the 5 patients studied before and after surgical treatment of their deformity, no significant improvement in pulmonary function was noted.

A polymorphism in the macrophage migration inhibitory factor promoter is associated with bronchopulmonary dysplasia.

Bronchopulmonary dysplasia (BPD) is a common adverse outcome of prematurity, causing severe morbidity and mortality. The cytokine macrophage migration inhibitory factor (MIF) has been recently shown to favor murine fetal lung development. In this prospective study, we evaluate the expression of MIF in the lung and in the serum of preterm infants (n = 50) and investigate whether the −173 G/C MIF promoter polymorphism is associated with the risk of BPD (n = 103). MIF was highly expressed in lung tissue from preterm infants. Serum MIF levels were measured by ELISA at d 1 after birth. MIF levels were increased [median (interquartile range), 71.01 (44.9–162.3) ng/mL], particularly in those infants with RDS [110.4 (59.4–239.2) ng/mL] compared with healthy adults [2.4 (1.2–5.0) ng/mL], (p < 0.001). The MIF −173*C allele, which predisposes to higher MIF production, was associated with a lower incidence of BPD (OR, 0.2; 95% CI, 0.04–0.93), independently from mechanical ventilation and oxygen exposure (p = 0.03). In conclusion, these data show that MIF expression is increased in lung and serum of preterm infants and suggest that the high producing MIF −173*C allele may be a protective factor for BPD.

Geographic variations in outcome of very low birth weight infants in Italy

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).

Intravenous correction of neonatal hypomagnesemia: effect on ionized magnesium.

OBJECTIVES Neonatal hypomagnesemia is defined as total magnesium (TMg) < or = 0.65 mmol/L (1.6 mg/dl). However, magnesium (Mg) deficiency and sufficiency overlap at serum values of 0.57 to 0.74 mmol/L (1.4 to 1.8 mg/dl). We hypothesized that (1) some infants with TMg < or = 0.65 mmol/L (1.6 mg/dl) have normal ionized Mg values (normal neonatal range 0.40 to 0.56 mmol/L (0.97 to 1.36 mg/dl)); (2) the dose (6.0 mg of elemental Mg/kg) used to correct hypomagnesemia does not lead to elevation of ionized Mg; (3) after intravenous magnesium sulfate infusion, ionized calcium increases in patients with low baseline ionized Mg and decreases in patients with normal baseline ionized Mg. STUDY DESIGN We recruited 22 neonates with TMg < or = 1.6 mg/dl. They received intravenous sulfate (6 mg elemental Mg/kg) over a 1-hour period. Serum TMg, ionized Mg, and ionized Ca were measured before and after magnesium sulfate infusion. An ion-selective electrode was used to allow direct measurement of ionized Mg and ionized Ca. RESULTS Thirteen (59%) of 22 neonates with TMg < or = 0.65 mmol/L (1.6 mg/dl) had normal IMg. In 7 (31%) of 22 cases ionized Mg increased slightly above 0.56 mmol/L (1.36 mg/dl); the maximum value was 0.61 mmol/L (1.48 mg/dl). The change in ionized Ca concentrations and the baseline ionized Mg value were inversely correlated (r = -0.79; p < 0.0001). CONCLUSIONS (1) Measurement of ionized Mg should prevent overdiagnosis and treatment of hypomagnesemia. (2) The dose used in this study is safe. (3) Ionized Mg concentrations are inversely correlated to the response of ionized Ca concentrations to an Mg load.