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2.
Acta Paediatr ; 2020 Jun 22.
Artigo em Inglês | MEDLINE | ID: mdl-32573026

RESUMO

we read with great interest the article by Pata et al. published online on June 2nd in the Journal (1). Indeed, the current Covid-19 epidemic in Italy and the associated, two months (March-April) strict lockdown have impacted on the overall epidemiology and use of adult and pediatric medical resources -also due to dramatic changes in lifestyle.

4.
J Infect ; 2020 May 21.
Artigo em Inglês | MEDLINE | ID: mdl-32445726
5.
Lancet Child Adolesc Health ; 4(6): 444-454, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32407710

RESUMO

BACKGROUND: Very low birthweight or preterm infants are at increased risk of adverse outcomes including sepsis, necrotising enterocolitis, and death. We assessed whether supplementing the enteral diet of very low-birthweight infants with lactoferrin, an antimicrobial protein, reduces all-cause mortality or major morbidity. METHODS: We did a multicentre, double-blind, pragmatic, randomised superiority trial in 14 Australian and two New Zealand neonatal intensive care units. Infants born weighing less than 1500 g and aged less than 8 days, were eligible and randomly assigned (1:1) using minimising web-based randomisation to receive once daily 200 mg/kg pasteurised bovine lactoferrin supplements or no lactoferrin supplement added to breast or formula milk until 34 weeks' post-menstrual age (or for 2 weeks, if longer), or until discharge from the study hospital if that occurred first. Designated nurses preparing the daily feeds were not masked to group assignment, but other nurses, doctors, parents, caregivers, and investigators were unaware. The primary outcome was survival to hospital discharge or major morbidity (defined as brain injury, necrotising enterocolitis, late-onset sepsis at 36 weeks' post-menstrual age, or retinopathy treated before discharge) assessed in the intention-to-treat population. Safety analyses were by treatment received. We also did a prespecified, PRISMA-compliant meta-analysis, which included this study and other relevant randomised controlled trials, to estimate more precisely the effects of lactoferrin supplementation on late-onset sepsis, necrotising enterocolitis, and survival. This trial is registered with the Australian and New Zealand Clinical Trials Registry, ACTRN12611000247976. FINDINGS: Between June 27, 2014, and Sept 1, 2017, we recruited 1542 infants; 771 were assigned to the intervention group and 771 to the control group. One infant who had consent withdrawn before beginning lactoferrin treatment was excluded from analysis. In-hospital death or major morbidity occurred in 162 (21%) of 770 infants in the intervention group and in 170 (22%) of 771 infants in the control group (relative risk [RR] 0·95, 95% CI 0·79-1·14; p=0·60). Three suspected unexpected serious adverse reactions occurred; two in the lactoferrin group, namely unexplained late jaundice and inspissated milk syndrome, but were not attributed to the intervention and one in the control group had fatal inspissated milk syndrome. Our meta-analysis identified 13 trials completed before Feb 18, 2020, including this Article, in 5609 preterm infants. Lactoferrin supplements significantly reduced late-onset sepsis (RR 0·79, 95% CI 0·71-0·88; p<0·0001; I2=58%), but not necrotising enterocolitis or all-cause mortality. INTERPRETATION: Lactoferrin supplementation did not improve death or major morbidity in this trial, but might reduce late-onset sepsis, as found in our meta-analysis of over 5000 infants. Future collaborative studies should use products with demonstrated biological activity, be large enough to detect moderate and clinically important effects reliably, and assess greater doses of lactoferrin in infants at increased risk, such as those not exclusively receiving breastmilk or infants of extremely low birthweight. FUNDING: Australian National Health and Medical Research Council.

6.
Am J Perinatol ; 37(8): 780-791, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32359226

RESUMO

The novel coronavirus disease 2019 (COVID-19) pandemic has urged the development and implementation of guidelines and protocols on diagnosis, management, infection control strategies, and discharge planning. However, very little is currently known about neonatal COVID-19 and severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) infections. Thus, many questions arise with regard to respiratory care after birth, necessary protection to health care workers (HCW) in the delivery room and neonatal intensive care unit (NICU), and safety of bag and mask ventilation, noninvasive respiratory support, deep suctioning, endotracheal intubation, and mechanical ventilation. Indeed, these questions have created tremendous confusion amongst neonatal HCW. In this manuscript, we comprehensively reviewed the current evidence regarding COVID-19 perinatal transmission, respiratory outcomes of neonates born to mothers with COVID-19 and infants with documented SARS-CoV-2 infection, and the evidence for using different respiratory support modalities and aerosol-generating procedures in this specific population. The results demonstrated that to date, neonatal COVID-19 infection is uncommon, generally acquired postnatally, and associated with favorable respiratory outcomes. The reason why infants display a milder spectrum of disease remains unclear. Nonetheless, the risk of severe or critical illness in young patients exists. Currently, the recommended respiratory approach for infants with suspected or confirmed infection is not evidence based but should include all routinely used types of support, with the addition of viral filters, proper personal protective equipment, and placement of infants in isolation rooms, ideally with negative pressure. As information is changing rapidly, clinicians should frequently watch out for updates on the subject. KEY POINTS: · Novel coronavirus disease 2019 (COVID-19) pandemic urged development of guidelines.. · Neonatal COVID-19 disease is uncommon.. · Respiratory outcomes in neonates seems favorable.. · Current neonatal respiratory care should continue.. · Clinicians should watch frequently for updates..


Assuntos
Manuseio das Vias Aéreas , Infecções por Coronavirus , Doenças do Recém-Nascido , Controle de Infecções , Transmissão Vertical de Doença Infecciosa/prevenção & controle , Pandemias , Pneumonia Viral , Manuseio das Vias Aéreas/métodos , Manuseio das Vias Aéreas/tendências , Betacoronavirus/isolamento & purificação , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/terapia , Prática Clínica Baseada em Evidências , Feminino , Humanos , Recém-Nascido , Doenças do Recém-Nascido/epidemiologia , Doenças do Recém-Nascido/prevenção & controle , Doenças do Recém-Nascido/terapia , Doenças do Recém-Nascido/virologia , Controle de Infecções/métodos , Controle de Infecções/organização & administração , Controle de Infecções/normas , Pandemias/prevenção & controle , Pneumonia Viral/diagnóstico , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Pneumonia Viral/terapia , Gravidez
7.
Pediatr Infect Dis J ; 39(5): 438-443, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32301920

RESUMO

BACKGROUND: Suspected early-onset sepsis (EOS) results in antibiotic treatment of a substantial number of neonates who are uninfected. We evaluated if an approach using serial physical examinations (SPEs) can reduce antibiotic exposure for suspected EOS in term neonates during the first 3 days of life, without affecting safety. METHODS: Within a quality-improvement framework, SPEs for 24-48 hours for neonates with suspected EOS was implemented in the neonatal intensive care unit, Stavanger, Norway. The proportion of neonates ≥37 weeks gestation exposed to antibiotics, antibiotic therapy-days and the safety outcome time from birth to start antibiotics were compared between a baseline period (April 2014-February 2016), when a risk factor based approach was used, and a post-SPE-implementation period (January 2017-November 2018). RESULTS: We included all term live born neonates (n = 17,242) in the 2 periods. There was a 57% relative reduction in neonates exposed to antibiotics; 2.9% in the baseline and 1.3% in the post-implementation period, P < 0.001. There was a 60% relative reduction in mean antibiotic therapy-days/1000 patient-days; from 320 to 129, P < 0.001, and a 50% relative reduction in time to initiate antibiotics in suspected EOS-cases, from median (interquartile range) 14 (5-28) to 7 (3-17) hours, P = 0.003. The incidence of culture-positive EOS remained unchanged. There were no infection-attributable deaths. CONCLUSIONS: Implementing SPE to guide empiric antibiotic therapy in term neonates with suspected EOS more than halved the burden of antibiotic exposure, without delay of antibiotic treatment of infected neonates or increased sepsis-related mortality.

9.
Vaccine ; 38(8): 2105-2114, 2020 Feb 18.
Artigo em Inglês | MEDLINE | ID: mdl-31776027

RESUMO

BACKGROUND: Pertussis immunization during pregnancy results in high pertussis antibody concentrations in young infants but may interfere with infant immune responses to post-natal immunization. METHODS: This phase IV, multi-country, open-label study assessed the immunogenicity and safety of infant primary vaccination with DTaP-HepB-IPV/Hib and 13-valent pneumococcal conjugate vaccine (PCV13). Enrolled infants (6-14 weeks old) were born to mothers who were randomized to receive reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap group) or placebo (control group) during pregnancy (270/7-366/7 weeks' gestation) with crossover immunization postpartum. All infants received 2 or 3 DTaP-HepB-IPV/Hib and PCV13 doses according to national schedules. Immunogenicity was assessed in infants pre- and 1 month post-primary vaccination. The primary objective was to assess seroprotection/vaccine response rates for DTaP-HepB-IPV/Hib antigens 1 month post-primary vaccination. RESULTS: 601 infants (Tdap group: 296; control group: 305) were vaccinated. One month post-priming, seroprotection rates were 100% (diphtheria; tetanus), ≥98.5% (hepatitis B), ≥95.9% (polio) and ≥94.5% (Hib) in both groups. Vaccine response rates for pertussis antigens were significantly lower in infants whose mothers received pregnancy Tdap (37.5-77.1%) versus placebo (90.0-99.2%). Solicited and unsolicited adverse event rates were similar between groups. Serious adverse events occurred in 2.4% (Tdap group) and 5.6% (control group) of infants, none were vaccination-related. CONCLUSIONS: Pertussis antibodies transferred during pregnancy may decrease the risk of pertussis infection in the first months of life but interfere with the infant's ability to produce pertussis antibodies, the clinical significance of which remains unknown. Safety and reactogenicity results were consistent with previous experience. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT02422264.

10.
Vaccine ; 38(8): 2095-2104, 2020 Feb 18.
Artigo em Inglês | MEDLINE | ID: mdl-31776029

RESUMO

BACKGROUND: Pertussis immunization during pregnancy is recommended in many countries. Data from large randomized controlled trials are needed to assess the immunogenicity, reactogenicity and safety of this approach. METHODS: This phase IV, observer-blind, randomized, placebo-controlled, multicenter trial assessed immunogenicity, transplacental transfer of maternal pertussis antibodies, reactogenicity and safety of a reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap) during pregnancy. Women received Tdap or placebo at 27-36 weeks' gestation with crossover ≤ 72-hour-postpartum immunization. Immune responses were assessed before the pregnancy dose and 1 month after, and from the umbilical cord at delivery. Superiority (primary objective) was reached if the lower limits of the 95% confidence intervals (CIs) of the pertussis geometric mean concentration (GMC) ratios (Tdap/control) in cord blood were ≥ 1.5. Solicited and unsolicited adverse events (AEs) and pregnancy-/neonate-related AEs of interest were recorded. RESULTS: 687 pregnant women were vaccinated (Tdap: N = 341 control: N = 346). Superiority of the pertussis immune response (maternally transferred pertussis antibodies in cord blood) was demonstrated by the GMC ratios (Tdap/control): 16.1 (95% CI: 13.5-19.2) for anti-filamentous hemagglutinin, 20.7 (15.9-26.9) for anti-pertactin and 8.5 (7.0-10.2) for anti-pertussis toxoid. Rates of pregnancy-/neonate-related AEs of interest, solicited general and unsolicited AEs were similar between groups. None of the serious AEs reported throughout the study were considered related to maternal Tdap vaccination. CONCLUSIONS: Tdap vaccination during pregnancy resulted in high levels of pertussis antibodies in cord blood, was well tolerated and had an acceptable safety profile. This supports the recommendation of Tdap vaccination during pregnancy to prevent early-infant pertussis disease. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT02377349.

11.
Paediatr Respir Rev ; 33: 35-44, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31060948

RESUMO

Respiratory syncytial virus (RSV) infection is a leading cause of hospitalisation in early childhood and palivizumab is the only licensed intervention for prevention. Palivizumab guidelines should reflect the latest evidence, in addition to cost-effectiveness and healthcare budgetary considerations. RSV experts from Europe, Canada and Israel undertook a systematic review of the evidence over the last 5 years and developed recommendations regarding prophylaxis in industrialised countries. Almost 400 publications were reviewed. This group recommended palivizumab for: preterm infants (<29 and ≤31 weeks gestational age [wGA] and ≤9 and ≤6 months of age, respectively; high-risk 32-35wGA), former preterm children ≤24 months with chronic lung disease/bronchopulmonary dysplasia, children ≤24 months with significant congenital heart disease; and other high-risk populations, such as children ≤24 months with Down syndrome, pulmonary/neuromuscular disorders, immunocompromised, and cystic fibrosis. Up to 5 monthly doses should be administered over the RSV season. It is our impression that the adoption of these guidelines would help reduce the burden of RSV.

13.
Am J Perinatol ; 36(S 02): S74-S76, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31238364

RESUMO

OBJECTIVE: The Marfan syndrome (MFS) is an autosomal dominant disorder of connective tissue resulting from pathogenic variants of the fibrillin-1 gene (FBN1) with skeletal, cardiac, and ocular involvement. STUDY DESIGN: We report on a full-term male neonate, who showed at birth characteristics and dysmorphisms suggestive of nMFS, combined with the detection of severe cardiovascular disease. A multidisciplinary team made up of neonatologists and pediatricians, cardiologists, geneticists, ophtalmologists, physiatrists and physioterapists was formed to manage this patient. RESULTS AND CONCLUSION: Early diagnosis of this rare condition is critical for adequate treatment and specific follow-up, and impacts significantly on prognosis.


Assuntos
Doenças do Recém-Nascido , Síndrome de Marfan , Eletrocardiografia , Humanos , Recém-Nascido , Masculino , Síndrome de Marfan/genética , Síndrome de Marfan/cirurgia , Prolapso da Valva Mitral/cirurgia , Mutação , Prolapso da Valva Tricúspide/cirurgia
14.
Am J Perinatol ; 36(S 02): S77-S82, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31238365

RESUMO

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.


Assuntos
Antivirais/uso terapêutico , Acesso aos Serviços de Saúde , Hospitalização/estatística & dados numéricos , Doenças do Prematuro/tratamento farmacológico , Palivizumab/uso terapêutico , Infecções por Vírus Respiratório Sincicial/tratamento farmacológico , Definição da Elegibilidade , Idade Gestacional , Humanos , Incidência , Recém-Nascido , Recém-Nascido Prematuro , Doenças do Prematuro/epidemiologia , Seguro de Serviços Farmacêuticos , Itália/epidemiologia , Infecções por Vírus Respiratório Sincicial/epidemiologia , Estudos Retrospectivos , Estações do Ano
15.
Am J Perinatol ; 36(S 02): S83-S90, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31238366

RESUMO

OBJECTIVE: This study was aimed to investigate the effects of physical activity on perineal outcomes at delivery according to the different levels and types of maternal physical activity before and during pregnancy. STUDY DESIGN: We prospectively evaluated the obstetrical and perineal outcomes of all consecutive women who delivered at the Del Ponte Hospital, in the period between July 2014 and September 2014. Women were divided into three groups according to the features of physical activity performed before pregnancy: group 1: "very sporty women," group 2: "moderately sporty women," and group 3: "inactive women." A subanalysis of our data was performed based on the specific type of sport activity, on the degree of involvement of perineal muscles during physical activity, and on the continuation/discontinuation of this activity during pregnancy. RESULTS: A total of 135, 84, and 85 women were included in group 1, group 2, and group 3, respectively. The demographic characteristics were comparable among all the groups. Sport activity during pregnancy was more frequent in groups 1 and 2 (59.3 and 53.6%, respectively, vs. 29.4% in group 3; p = 0.003). No differences among groups were detected in terms of perineal outcomes. A lower rate of episiotomy/lacerations ≥ 2nd degree was found among women who practiced sports that specifically involved the perineal muscles and who continued this practice during pregnancy. CONCLUSION: Perineal outcomes are not influenced by the intensity of sport activity performed before/during pregnancy. Continuous sports during pregnancy that specifically train the perineal muscles are associated with a lower rate of episiotomy and perineal lacerations ≥ 2nd degree.


Assuntos
Atletas , Episiotomia/estatística & dados numéricos , Exercício Físico , Complicações do Trabalho de Parto/epidemiologia , Períneo/lesões , Adulto , Feminino , Humanos , Lacerações/epidemiologia , Gravidez , Estudos Prospectivos
16.
Am J Perinatol ; 36(S 02): S91-S98, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31238367

RESUMO

OBJECTIVE: To systematically evaluate pregnancy and labor course, obstetrical complications, and maternal and neonatal outcomes in women with endometriosis, stratifying according to the specific location of the disease. STUDY DESIGN: We retrospectively analyzed our prospectively maintained obstetrical database from January 2011 to August 2014 to identify all women with a previous histological diagnosis of endometriosis who delivered at our institution (cases). We divided the cases according to the specific location of the disease (deep infiltrating endometriosis, ovarian endometriosis, and peritoneal endometriosis). As controls, we identified all unaffected women who delivered in the year 2013. To avoid the confounding effect of parity, we limited our analysis to nulliparous women. RESULTS: A total of 118 nulliparous women with endometriosis and 1,690 nulliparous controls were identified. Women with endometriosis were significantly older, had a lower body mass index, and had a higher incidence of assisted reproductive technology. The duration of pregnancy was significantly shorter among women with endometriosis. A higher incidence of placenta previa (3.4 vs. 0.5%; p = 0.006), hypertension (11 vs. 5.9%; p = 0.04), cesarean section (41.5 vs. 24.2%; p < 0.0001), and vacuum delivery (10.1 vs. 2.9%; p = 0.006) was found in women with endometriosis. Neonatal outcomes were similar between groups. The incidence of placenta previa in patients with deep endometriosis was 11.7 versus 0.5% among controls (p < 0.0001), whereas in women with ovarian and peritoneal endometriosis, it was similar to the controls. CONCLUSION: Women with endometriosis have a higher incidence of vacuum delivery, cesarean section, and placenta previa compared with unaffected women. The higher risk of placenta previa is attributable exclusively to women with deep endometriosis. Neonatal outcomes are unaffected by the presence of the disease.


Assuntos
Cesárea/estatística & dados numéricos , Endometriose , Placenta Prévia/epidemiologia , Resultado da Gravidez , Adolescente , Adulto , Índice de Massa Corporal , Estudos de Casos e Controles , Endometriose/cirurgia , Feminino , Humanos , Incidência , Pessoa de Meia-Idade , Paridade , Gravidez , Complicações na Gravidez/epidemiologia , Técnicas de Reprodução Assistida , Estudos Retrospectivos , Vácuo-Extração/estatística & dados numéricos , Adulto Jovem
17.
Am J Perinatol ; 36(S 02): S115-S119, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31238371

RESUMO

BACKGROUND: The application of noninvasive ventilation (NIV) modalities from birth in the delivery room (DR) during fetal-neonatal transition reduces the need for invasive mechanical ventilation, mortality, and bronchopulmonary dysplasia (BPD). The use of a RAM nasal cannula (RAM NC) in the DR for resuscitation results in less need for intubation, chest compressions, and epinephrine administration when compared with using a face mask for PPV in the DR. OBJECTIVE: To evaluate the need for endotracheal intubation in the DR among extremely low gestational age neonates treated at birth with sustained inflation (SI) followed by a nasal continuous positive airway pressure (NCPAP) (range: 6-8 cm of H2O) delivered through the RAM NC. STUDY DESIGN: A retrospective study was conducted to compare the use of NIV techniques in the DR and the need for intubation in the DR in premature infants 23 to 28 weeks' gestational age from December 2016 to July 2018 (group A). These data were compared with those of premature inborn infants with similar GA born between April 2015 and November 2016 (group B). In the DR, immediately after birth, neonates in group A received SI through RAM NC followed by CPAP ranging from 6 to 8 cm H2O, whereas the neonates in group B were treated in the DR with SI administered through a face mask followed by the application of CPAP of 5 cm H2O delivered through a nasopharyngeal tube. RESULTS: A total of 65 preterm infants 23 to 28 weeks of gestational age, 31 in group A and 34 in group B, were included in the study. The percentage of neonates intubated in the DR was significantly lower in group A (p < 0.008). In both groups, no neonates died in the DR, and no one required epinephrine and/or chest compressions. For those neonates who did not require intubation in the DR, there was no significant difference in the average FiO2 on arrival in the neonatal intensive care unit, rate of intubation within 24 hours, and use of surfactant. The incidence of BPD was similar in the two groups. Only one infant in group A developed moderate BPD, and no one needed oxygen and/or ventilatory assistance at discharge. Mortality was similar in the two groups, with a slight prevalence in group B (27.7 vs. 19.2%). CONCLUSION: SI with RAM NC followed by NCPAP ranging from 6 to 8 cm H2O, administered with RAM NC resulted in a significant reduction of intubation in the DR.


Assuntos
Cânula , Pressão Positiva Contínua nas Vias Aéreas , Lactente Extremamente Prematuro , Ventilação não Invasiva/métodos , Ressuscitação/métodos , Salas de Parto , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Doenças do Prematuro , Intubação Intratraqueal , Masculino , Máscaras , Estudos Retrospectivos
18.
Am J Perinatol ; 36(S 02): S120-S125, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31238372

RESUMO

BACKGROUND: Lactoferrin is the major antimicrobial protein in human milk. In our randomized controlled trial (RCT) of bovine lactoferrin (BLF) supplementation in preterm neonates, BLF reduced late-onset sepsis (LOS). Mother's own milk (MM) contains higher concentrations of lactoferrin than donor milk or formula, but whether BLF is more effective in infants who receive formula or donor milk is uncertain. AIM: To evaluate the incidence of LOS in preterm infants fed MM and in those fed formula and/or donor milk. STUDY DESIGN: This is a (A) post hoc subgroup analysis, in our RCT of BLF, of its effects in preterm infants fed MM, with or without formula, versus those fed formula and/or donor milk (no-MM) and (B) post hoc meta-analysis, in our RCT of BLF and in the ELFIN (Enteral Lactoferrin in Neonates) RCT, of the effect of BLF in subgroups not exclusively fed MM. RESULTS: (A) Of 472 infants in our RCT, 168 were randomized to placebo and 304 were randomized to BLF. Among MM infants, LOS occurred in 22/133 (16.5%) infants randomized to placebo and in 14/250 (5.6%) randomized to BLF (relative risk or risk ratio (RR): 0.34; relative risk reduction (RRR): 0.66; 95% confidence interval (95% CI) for RR: 0.18-0.64; p < 0.0008). Among no-MM infants, LOS occurred in 7/35 (20.0%) randomized to placebo and in 2/54 (3.7%) randomized to BLF (RR: 0.19; RRR: 0.81; 95% CI for RR: 0.16-0.96; p = 0.026). In multivariable logistic regression analysis, there was no interaction between BLF treatment effect and type of feeding (p = 0.628). (B) In 1,891 infants not exclusively fed MM in our RCT of BLF and in the ELFIN RCT, BLF reduced the RR of LOS by 18% (RR: 0.82; 95% CI: 0.71-0.96; p = 0.01). CONCLUSION: Adequately powered studies should address the hypothesis that BLF is more effective in infants fed formula or donor milk than those fed MM. Such studies should evaluate whether a specific threshold of total lactoferrin intake can be identified to protect such patients from LOS.


Assuntos
Anti-Infecciosos/uso terapêutico , Fórmulas Infantis/química , Doenças do Prematuro/prevenção & controle , Recém-Nascido Prematuro , Lactoferrina/uso terapêutico , Leite Humano/química , Sepse/prevenção & controle , Animais , Bovinos , Humanos , Recém-Nascido , Modelos Logísticos , Ensaios Clínicos Controlados Aleatórios como Assunto
19.
Am J Perinatol ; 36(S 02): S126-S133, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31238373

RESUMO

OBJECTIVE: We analyzed the fungal ecology of a neonatal intensive care unit (NICU) over a period of 20 consecutive years following the introduction of routine fluconazole prophylaxis for all very low birth weight (VLBW; <1,500 g at birth) preterm babies. The aim was to detect the possible appearance of any ecological shifts toward the emergence of native fluconazole-resistant (NFR) fungal species. STUDY DESIGN: This was a retrospective analysis of clinical and microbiological data of VLBW preterm neonates admitted to a large tertiary NICU in Italy from 1997 to 2016 and surviving more than 3 days. Colonization and infection incidence rates, both for fluconazole-sensitive Candida spp and NFR Candida spp, were calculated for each year. We compared the first 4-year period without prophylaxis (1997-2000) with the last 16-year period with use of routine fluconazole prophylaxis (2000-2016). RESULTS: Overall, the incidence of fungal colonization significantly decreased after the introduction of prophylaxis (from 43.4% to 16.5%) as well as the systemic fungal infection incidence (from 16% to 3.7%). The proportion of colonization and infection by NFR Candida spp, on the other hand, did not increase, remaining stable throughout the 16 years of exposure to fluconazole. During the prophylaxis period, 42 of 1,172 VLBW neonates were colonized by NFR species (3.6%), and of them 11 developed a systemic infection (0.9%). During the preprophylaxis period, colonization by these particular species affected 11 of 285 VLBW neonates (3.8%), and a systemic infection involved 4 neonates (1.4%). CONCLUSION: Fluconazole prophylaxis is effective in decreasing Candida colonization and systemic infections in preterm neonates in NICU and did not cause emergence or shifts toward NFR Candida spp over a 16-year surveillance period.


Assuntos
Antifúngicos/uso terapêutico , Candida/isolamento & purificação , Candidíase/prevenção & controle , Farmacorresistência Fúngica , Fluconazol/uso terapêutico , Doenças do Prematuro/prevenção & controle , Recém-Nascido de muito Baixo Peso , Unidades de Terapia Intensiva Neonatal , Candida/efeitos dos fármacos , Candidíase/diagnóstico , Candidíase/epidemiologia , Contagem de Colônia Microbiana , Feminino , Idade Gestacional , Humanos , Incidência , Recém-Nascido , Recém-Nascido Prematuro , Doenças do Prematuro/epidemiologia , Itália , Masculino , Testes de Sensibilidade Microbiana , Estudos Retrospectivos
20.
Am J Perinatol ; 36(S 02): S134-S138, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31238374

RESUMO

OBJECTIVE: Subcutaneous fat necrosis (SCFN) is a rare condition that may occur in the neonatal period. SCFN is an inflammatory disorder of the adipose tissue, usually found in full-term healthy infants who have a history of intrauterine or perinatal distress. It is usually a self-limited condition; however, in some cases, it can get complicated, leading to severe hypercalcemia that may be life-threatening. STUDY DESIGN: We report and describe a classic presentation of SCFN that led to severe hypercalcemia refractory to standard treatment. The diagnosis of SCFN was made based on the finding of subcutaneous nodules and of hypercalcemia. The serum calcium level reached 16.6 mg/dL. Hypercalcemia was treated first with intravenous infusions of fluids and furosemide and then of methylprednisolone. This standard treatment was not effective; therefore, we administered a single low dose of zoledronic acid, which, in turn, was efficacious in ultimately managing the hypercalcemia. CONCLUSION: Our case shows how a single low dose of zoledronic acid was safe and effective in managing severe hypercalcemia unresponsive to conventional treatment while minimizing the risk of hypocalcemic rebounds.


Assuntos
Conservadores da Densidade Óssea/administração & dosagem , Necrose Gordurosa/complicações , Hipercalcemia/tratamento farmacológico , Ácido Zoledrônico/administração & dosagem , Cálcio/sangue , Resistência a Medicamentos , Feminino , Furosemida/uso terapêutico , Glucocorticoides/uso terapêutico , Humanos , Hipercalcemia/etiologia , Recém-Nascido , Metilprednisolona/uso terapêutico , Inibidores de Simportadores de Cloreto de Sódio e Potássio/uso terapêutico , Gordura Subcutânea , Nascimento a Termo
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