Restricted Palivizumab Recommendations and the Impact on RSV Hospitalizations among Infants Born at > 29 Weeks of Gestational Age: An Italian Multicenter Study.

OBJECTIVE: Premature infants have the highest risk of being hospitalized with respiratory syncytial virus (RSV) infections. Palivizumab is the only licensed agent for RSVhospitalization (RSVH) prophylaxis in infants born at < 35 weeks of gestational age (wGA). In 2016, the Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]) has restricted the eligibility for reimbursement to infants at high risk of RSVH, ruling out palivizumab administration for infants born at > 29 wGA. The aim of the present study was to compare the incidence of RSVH in two consecutive epidemic seasons (2015-2016 vs. 2016-2017), that is, before and after the new AIFA recommendations on palivizumab eligibility. STUDY DESIGN: This was a noninterventional retrospective cohort study conducted at three neonatal intensive care units (NICUs) in northern Italy. Infants born at 29 and 35 wGA between March 15, 2015 and March 14, 2017 were enrolled for this study. Electronic medical charts were reviewed and parents were interviewed by telephone. Data were collected on neonatal course during NICU stay, palivizumab administration, and hospitalizations related to respiratory infections during the 1st year of life, comparing the infants born in season 1 with season 2. RESULTS: Of 632 eligible infants, data were available for 536 (262 in season 1 and 274 in season 2). Overall, RSVH occurred 1.9 and 5.1% in infants in seasons 1 and 2, respectively (odds ratio [OR] = 2.77; 95% confidence interval [CI]: 0.98-7.8, p = 0.045). When the analysis was limited to patients not exposed to palivizumab, RSVHs were recorded for 1.8 and 5.9% infants in seasons 1 and 2, respectively (OR = 3.42; 95% CI: 0.96-12.20, p = 0.045). It is noteworthy that the incidence of hospital admissions for respiratory viruses other than RSV did not differ between the two seasons. CONCLUSION: Restricting eligibility for palivizumab reimbursement led to a significant increase in RSVH but had no impact on hospitalizations for other respiratory viruses. Future decisions on palivizumab prescription and coverage rules should be driven by a careful assessment of the cost-benefit ratio.

Role of Lactoferrin in Neonates and Infants: An Update.

Lactoferrin is one of the most represented and important bioactive proteins in human and mammal milk. In humans, lactoferrin is responsible for several actions targeting anti-infective, immunological, and gastrointestinal domains in neonates, infants, and young children. Evidence-based data vouch for the ability of supplemented lactoferrin to prevent sepsis and necrotizing enterocolitis in preterm infants and to reduce the burden of morbidity related to gastrointestinal and respiratory pathogens in young children. However, several issues remain pending regarding answers and clarification related to quality control, correct intakes, optimal schedules and schemes of supplementations, interactions with probiotics, and different types of milk and formulas. This review summarizes the current evidence regarding lactoferrin and discusses the areas in need of further guidance prior to the adoption of strategies that include a routine use of lactoferrin in neonates and young children.

Interaction between healthcare professionals and parents is a key determinant of parental distress during childhood hospitalisation for respiratory syncytial virus infection (European RSV Outcomes Study [EROS]).

AIM: We characterised the distress that parents experienced when their child was hospitalised for respiratory syncytial virus (RSV) infection. METHODS: This survey-based, observational study was conducted during 2014-2015. Meetings were held in Spain and Italy, with 24 parents of RSV hospitalised infants and 11 healthcare professionals experienced in RSV, which identified 110 factors related to parental distress. The resulting questionnaire was completed by another 105 Spanish and Italian parents and 56 healthcare professionals, to assess the impact these factors had on parental distress, using a scale from 0 to 10 (very unimportant to very important). RESULTS: The five most important factors for parents were: healthcare professionals' awareness of the latest developments, readmission, reinfections, painful procedures and positive experiences with healthcare professionals. Healthcare professionals associated only medical factors with a meaningful impact on parents. Half of the six medical factors were given similar importance by both groups and the overall scoring for the 110 factors was comparable, with a correlation coefficient of 0.80. A primary concern on discharge was ongoing support. CONCLUSION: The relationship between parents and healthcare professionals was a significant factor in determining parental distress. Healthcare professionals appeared to have a good understanding of the overall impact on parents, particularly the key medical factors.

Outcomes of Infants Receiving Palivizumab Prophylaxis for Respiratory Syncytial Virus in Canada and Italy: An International, Prospective Cohort Study.

BACKGROUND: Respiratory syncytial virus (RSV) infection frequently results in RSV-related hospitalization (RSVH) in young infants. We examined the outcomes of palivizumab recipients within the Canadian Registry (CARESS) and the Torino-Verona Italian Registry over the 2002-2014 RSV seasons. METHODS: RSVHs were captured during the study seasons. Premature infants who received palivizumab (≤35 completed weeks' gestational age; group1) were compared with infants given palivizumab for underlying disorders regardless of gestational age (group 2). Variables and between-group incidences were analyzed. Risk factors associated with RSVH were assessed by logistic regression. RESULTS: A total of 14,468 palivizumab-exposed infants were enrolled (group 1, n = 9093; group 2, n = 4856; miscellaneous, n = 519). RSVH was significantly more frequent in group 2 (211/4856, 4.34%) versus group 1 infants (216/9093, 2.37% [relative risk 1.93; 95% confidence interval (CI): 1.60-2.33; P < 0.0001]). Infants with neuromuscular disorders (7.88%), airway anomalies (5.95%), bronchopulmonary dysplasia (4.75%) and hemodynamically significant congenital heart disease (4.10%) had the highest RSVH incidences. After multivariable logistic regression, only neuromuscular disease [odds ratio [OR] 4.29; 95% CI: 2.30-8.00; P < 0.01], airway anomalies (OR 3.23; 95% CI: 1.92-5.43; P < 0.01), Down syndrome (OR 2.25; 95% CI: 1.31-3.89; P < 0.01), hemodynamically significant congenital heart disease (OR 2.24; 95% CI: 1.52-3.31; P < 0.001), prematurity ≤28 completed weeks' gestational age (OR 1.82; 95% CI: 1.29-2.58; P < 0.001) and bronchopulmonary dysplasia (OR 1.81; 95% CI: 1.31-2.50; P < 0.001) significantly predicted RSVH. No significant association was detected with the number of doses administered or the time elapsed after the previous dose. CONCLUSIONS: RSVH rates are higher in infants given palivizumab for reasons other than prematurity. It is uncertain whether these findings relate to inadequate current palivizumab dosing protocols or to a specific increased RSVH risk inherent in infants with severe underlying comorbidities.

Candida pneumonia in a term infant after prolonged use of inhaled corticosteroids for bronchopulmonary dysplasia (BPD).

Candida spp. frequently cause invasive fungal disease in neonates, and many organs or apparatus can be involved through bloodstream dissemination. Though Candida spp. can heavily colonize the upper and lower respiratory tract, an end-organ localization to the lung is not frequent and acquisition via descending/respiratory route is a questioned entity. Here we report the case of a young infant affected by bronchopulmonary dysplasia (BPD) and treated with inhaled steroids who developed Candida pneumonia likely acquired through descending route.

Subclinical varicocele and sports: a longitudinal study.

OBJECTIVES: To evaluate the influence of physical activity on the evolution of subclinical varicocele because subclinical and clinical varicoceles are common in adolescents. METHODS: The study enrolled healthy male volunteers (athletes and nonathletes) and athletes with subclinical varicocele from October 2006 to March 2007. A fourth group of nonathletes with subclinical varicocele was created. Subclinical varicocele was defined as spermatic vein reflux detected with Doppler velocimetry only with the Valsalva maneuver. All patients were pubertal boys of 14-16 years old. Those practicing sports on a regular basis ≥3 times weekly for ≥2 consecutive hours were considered athletes. The boys were examined every year for 3 years from October 2006 to March 2010. At each examination, each patient underwent Doppler velocimetry and testicular volume measurements with a standard orchidometer. The rate of progression to a clinically palpable varicocele and its relationship to sport practice was also assessed. RESULTS: The follow-up compliance rate was 80%. The rate of progression to a clinically palpable varicocele was significantly greater in the athletes with a subclinical varicocele than in the healthy group (athletes and nonathletes) without a subclinical varicocele (36% vs 5%, respectively; P < .05). The probability of developing a subclinical varicocele for healthy athletes and healthy nonathletes was similar (23% vs 20%, respectively). CONCLUSIONS: Subclinical varicocele should be considered as the first stage of varicocele development. Although sports practice seemed to cause progression to a clinical varicocele, this finding was confirmed only in patients already affected by spermatic vein reflux (subclinical varicocele).

Post-discharge supplementation of vitamins and minerals for preterm neonates.

Ninety percent of premature babies has nutritional deficiency at discharge. It is very important that not only carbohydrates, proteins, fats, but also mineral salts, and vitamins are in quantities and adequate quality according to the needs of the various scientific neonatal and nutrition programs so as to avoid any shortcomings or excess. The growth, neurodevelopmental outcome and quality of life depend on, among other factors, an adequate nutritional supply with essential nutrients including minerals. It is now recommended that all infants and children, including adolescents, have a minimum daily intake of 400 IU of vitamin D beginning soon after birth. The standard initial dose of vitamin K1 for full term infants (1.0 mg) may be too high for premature infants. The addition of folate and especially vitamin B-12 with formula feedings, provided an effective and nontoxic means of reducing anemia of prematurity. Several investigators have reported higher plasma concentrations of selenium and glutathione peroxidase in preterm infants fed with selenium-supplemented formula than in infants fed with unsupplemented formula.

Graves' ophthalmopathy evolution studied by MRI during childhood and adolescence.

Pediatric patients with Graves' disease (n=26) were studied longitudinally by magnetic resonance imaging of the orbits, allowing an assessment of the enlargement of the extraocular muscles and orbital volume variations. The positive outcome of Graves' ophthalmopathy correlated with low TRAb (autoantibodies to thyroid-stimulating hormone receptor) titers at diagnosis and during follow-up and with prepubertal condition at diagnosis.