ABSTRACT
Considering the spectrum of benefits of breast milk feeding, determining the essential components of an infant's only food-mother's milk-seems justified, especially in the case of those whose deficiency (e.g., iodine) may result in developmental disorders. The main aim of this study was the determination of the total iodine content of breast milk (including colostrum and mature milk). A secondary objective was to assess the influence of factors such as the type of delivery, hypothyroidism, gestational diabetes or the stage of lactation on this parameter. The study materials were colostrum and milk after 1 (n = 14), 2 and 3 months (n = 8) of lactation with a range of iodine concentrations (µg/L): 195-1648 and 170-842, 174-650 and 273-751, respectively. Iodine was determined using the inductively coupled plasma mass spectrometry (ICP-MS). Multivariate statistical analysis revealed, e.g., that delivery by caesarean section or dose of L-thyroxine taken by women to normalise thyroid hormones, had a significant effect on iodine concentrations in breast milk. Further research aimed at assessing the quality of breast milk should also include determining the factors influencing it.
ABSTRACT
Respiratory syncytial virus (RSV) is the most common pathogen causing respiratory tract infections in infants, affecting over 90% of children within the first two years of life. It may cause lower respiratory tract infections, which constitute a significant healthcare burden both in the primary and secondary care settings. Meanwhile, the data regarding RSV disease in Poland is scarce, and published data significantly differs from the numbers reported for other countries with longstanding surveillance and reporting systems. A literature review and an expert panel were conducted to (1) understand the healthcare burden of RSV infections in Poland; (2) collect data on infection seasonality, patient pathway, and management patterns; and (3) evaluate RSV infection surveillance in Poland. According to the literature, RSV is the major agent responsible for non-influenza respiratory diseases in Poland. The reported rates of hospitalization for RSV infections are 267.5/100,000 for children under 5 years of age and 1132.1/100,000 for those under 1 year of age. Comparisons with data from other countries suggest that these values may be underestimated, possibly due to insufficient access to microbiological testing and a low awareness of RSV. Infections occur mainly between December and April, however, this pattern has changed following the implementation of preventive measures for coronavirus disease 2019 in the past few years. According to available reports, bronchodilators, antibiotics, corticosteroids, and X-ray imaging have been frequently used. The surveillance system in Poland has limitations, but these may be overcome due to recent changes in healthcare law as well as the availability and reimbursement of diagnostic tests.
ABSTRACT
BACKGROUND: The use of cerebral oximetry monitoring in the care of extremely preterm infants is increasing. However, evidence that its use improves clinical outcomes is lacking. METHODS: In this randomized, phase 3 trial conducted at 70 sites in 17 countries, we assigned extremely preterm infants (gestational age, <28 weeks), within 6 hours after birth, to receive treatment guided by cerebral oximetry monitoring for the first 72 hours after birth or to receive usual care. The primary outcome was a composite of death or severe brain injury on cerebral ultrasonography at 36 weeks' postmenstrual age. Serious adverse events that were assessed were death, severe brain injury, bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and late-onset sepsis. RESULTS: A total of 1601 infants underwent randomization and 1579 (98.6%) were evaluated for the primary outcome. At 36 weeks' postmenstrual age, death or severe brain injury had occurred in 272 of 772 infants (35.2%) in the cerebral oximetry group, as compared with 274 of 807 infants (34.0%) in the usual-care group (relative risk with cerebral oximetry, 1.03; 95% confidence interval, 0.90 to 1.18; P = 0.64). The incidence of serious adverse events did not differ between the two groups. CONCLUSIONS: In extremely preterm infants, treatment guided by cerebral oximetry monitoring for the first 72 hours after birth was not associated with a lower incidence of death or severe brain injury at 36 weeks' postmenstrual age than usual care. (Funded by the Elsass Foundation and others; SafeBoosC-III ClinicalTrials.gov number, NCT03770741.).
Subject(s)
Infant, Extremely Premature , Infant, Premature, Diseases , Oximetry , Humans , Infant , Infant, Newborn , Brain Injuries/diagnostic imaging , Brain Injuries/etiology , Bronchopulmonary Dysplasia/etiology , Cerebrovascular Circulation , Infant, Premature, Diseases/diagnosis , Infant, Premature, Diseases/mortality , Infant, Premature, Diseases/therapy , Oximetry/methods , Cerebrum , Ultrasonography , Retinopathy of Prematurity/etiology , Enterocolitis, Necrotizing/etiology , Neonatal Sepsis/etiologyABSTRACT
Introduction: All epidemiological studies suggest that vitamin D deficiency is prevalent among the Polish general population. Since vitamin D deficiency was shown to be among the risk factors for many diseases and for all-cause mortality, concern about this problem led us to update the previous Polish recommendations. Methods: After reviewing the epidemiological evidence, case-control studies and randomized control trials (RCTs), a Polish multidisciplinary group formulated questions on the recommendations for prophylaxis and treatment of vitamin D deficiency both for the general population and for the risk groups of patients. The scientific evidence of pleiotropic effects of vitamin D as well as the results of panelists' voting were reviewed and discussed. Thirty-four authors representing different areas of expertise prepared position statements. The consensus group, representing eight Polish/international medical societies and eight national specialist consultants, prepared the final Polish recommendations. Results: Based on networking discussions, the ranges of total serum 25-hydroxyvitamin D concentration indicating vitamin D deficiency [<20 ng/mL (<50 nmol/L)], suboptimal status [20-30 ng/mL (50-75 nmol/L)], and optimal concentration [30-50 ng/mL (75-125 nmol/L)] were confirmed. Practical guidelines for cholecalciferol (vitamin D3) as the first choice for prophylaxis and treatment of vitamin D deficiency were developed. Calcifediol dosing as the second choice for preventing and treating vitamin D deficiency was introduced. Conclusions: Improving the vitamin D status of the general population and treatment of risk groups of patients must be again announced as healthcare policy to reduce a risk of spectrum of diseases. This paper offers consensus statements on prophylaxis and treatment strategies for vitamin D deficiency in Poland.
Subject(s)
Dietary Supplements , Vitamin D Deficiency , Humans , Poland/epidemiology , Vitamin D , Vitamin D Deficiency/drug therapy , Vitamin D Deficiency/epidemiology , Vitamin D Deficiency/prevention & control , Vitamins , Cholecalciferol , CalcifediolABSTRACT
Background: Transient tachypnea of the newborn (TTN), which results from inadequate absorption of fetal lung fluid, is the most common cause of neonatal respiratory distress. Stimulation of ß-adrenergic receptors enhances alveolar fluid absorption. Therefore, the ß2-adrenergic receptor agonist salbutamol has been proposed as a treatment for TTN. This study aims to evaluate the efficacy and safety of salbutamol as supportive pharmacotherapy together with non-invasive nasal continuous positive airway pressure (NIV/nCPAP) for the prevention of persistent pulmonary hypertension of the newborn (PPHN) in infants with TTN. Methods and analysis: This multicenter, double-blind, phase III trial will include infants with a gestational age between 32 and 42 weeks who are affected by respiratory disorders and treated in eight neonatal intensive care units in Poland. A total of 608 infants within 24â h after birth will be enrolled and randomly assigned (1:1) to receive nebulized salbutamol with NIV or placebo (nebulized 0.9% NaCl) with NIV. The primary outcome is the percentage of infants with TTN who develop PPHN. The secondary outcomes are the severity of respiratory distress (assessed with the modified TTN Silverman score), frequency of need for intubation, duration of NIV and hospitalization, acid-base balance (blood pH, partial pressure of O2 and CO2, and base excess), and blood serum ionogram for Na+, K+, and Ca2+. Discussion: The Respiratory Failure with Salbutamol (REFSAL) study will be the first clinical trial to evaluate the efficacy and safety of salbutamol in the prevention of persistent pulmonary hypertension in newborns with tachypnea, and will improve short term outcomes. If successful, the study will demonstrate the feasibility of early intervention with NIV/nCPAP together with nebulized salbutamol in the management of TTN. Ethics and dissemination: The study protocol was approved by the Bioethics Committee of the Medical University of Warsaw, Warsaw, Poland on November 16, 2020 (decision number KB/190/2020). All procedures will follow the principles of the Declaration of Helsinki. The results of the study will be submitted for knowledge translation in peer-reviewed journals and presented at national and international pediatric society conferences. Clinical Trial Registration: It is registered at ClinicalTrials.gov NCT05527704, EudraCT 2020-003913-36; Protocol version 5.0 from 04/01/2022.
ABSTRACT
Staphylococci are among the most frequent human microbiota components associated with the high level of bloodstream infection (BSI) episodes. In predisposed patients, there is a high risk of transformation of BSI episodes to sepsis. Both bacterial and host factors are crucial for the outcomes of BSI and sepsis. The highest rates of BSI episodes were reported in Africa, where these infections were up to twice as high as the European rates. However, there remains a great need to analyze African data for comprehensive quantification of staphylococcal BSI prevalence. The lowest rates of BSI exist in Australia. Asian, European, and North American data showed similar frequency values. Worldwide analysis indicated that both Staphylococcus aureus and coagulase-negative staphylococci (CoNS) are the most frequent BSI agents. In the second group, the most prevalent species was Staphylococcus epidermidis, although CoNS were not identified at the species level in many studies. The lack of a significant worldwide decrease in BSI episodes indicates a great need to implement standardized diagnostic methods and research etiological factors using advanced genetic methods.
Subject(s)
Bacteremia/microbiology , Staphylococcal Infections/microbiology , Staphylococcus/pathogenicity , Africa/epidemiology , Animals , Bacteremia/epidemiology , Humans , Staphylococcal Infections/epidemiology , Staphylococcus/genetics , Staphylococcus/isolation & purification , Staphylococcus/physiology , VirulenceABSTRACT
Rapid spread of severe acute respiratory syndrome coranovirus-2 virus (SARS-CoV-2) caused the pandemic of Coronavirus Disease 19 (COVID-19). Clinical course of the disease presents symptoms mainly from the respiratory system such as: cough, dyspnea and fever, and among some patients, can deteriorate even further to acute respiratory distress syndrome (ARDS), eventually leading to death. This outbreak, as well as previous ones (SARS, MERS) pose a significant challenge for health care managers, epidemiologists and physicians. Below we are presenting the clinical profile of the COVID-19 among special group of patients; pregnant women and newborns, who require special clinical management during hospitalization. In the summary of this manuscript, we present practical guidelines for managing pregnant women infected with SARS-CoV-2, labor and care of the newborn of a positive mother, as well as practical guidelines for COVID-19 vaccinations. It is important to stress, that this manuscript is based on information available as of December 2020.
Subject(s)
COVID-19/epidemiology , Pregnancy Complications, Infectious/epidemiology , Prenatal Care , SARS-CoV-2 , COVID-19/prevention & control , Female , Humans , Infant, Newborn , Infectious Disease Transmission, Vertical/prevention & control , Poland , Practice Guidelines as Topic , Pregnancy , Pregnancy Complications, Infectious/etiology , Pregnancy Complications, Infectious/prevention & control , Risk FactorsABSTRACT
The gut microbiota plays a pivotal role in the maintenance of human health. Numerous factors, including the mode of delivery, impact early gut colonization in newborns. Recent research focuses on the use of probiotics in the prevention of gut dysbiosis in newborns delivered by cesarean section (CS). The objective of this study was to determine whether a probiotic supplement given to newborns delivered by CS during their stay in the maternity ward alters the pattern of early gut colonization by lactic acid bacteria versus potential pathogens. A prospective, randomized trial was conducted. In total, 150 newborns, born at 38-40 weeks gestational age and delivered by CS, were included in the study. They were randomized into the intervention group, supplemented orally with a probiotic containing Bifidobacterium breve PB04 and Lactobacillus rhamnosus KL53A, and the control group. Stool samples were obtained on days 5 and 6 of life and after one month of life and were analyzed for the presence and abundance of the main groups of bacteria. An application of two probiotic bacteria during the first days of life after CS resulted in quick and abundant colonization by days 5 and 6, with high populations of L. rhamnosus and B. breve. The applied bacterial strains were present in the majority of neonates one month after. The supplementation of term neonates delivered by cesarean section immediately after birth with a mixture of L. rhamnosus and B. breve enriched the gut microbiota composition with lactic acid bacteria.
Subject(s)
Bifidobacterium breve , Cesarean Section , Dietary Supplements , Dysbiosis/prevention & control , Gastrointestinal Microbiome , Infant Nutritional Physiological Phenomena/physiology , Infant, Newborn/physiology , Lacticaseibacillus rhamnosus , Probiotics/administration & dosage , Dysbiosis/microbiology , Humans , Prospective Studies , Time FactorsABSTRACT
BACKGROUND: There are only a few reports in the literature about translocation of coagulase-negative staphylococci (CoNS) as a primary cause of sepsis in neonates, although CoNS are among a short list of "translocating" bacteria when present in abundance. METHODS: 468 blood samples, 119 stool samples, and 8 catheter tips, from 311 neonates, were tested for presence of microorganisms. CoNS strains isolated from the blood and stool or from blood and catheter tip of the same newborn at approximately the same time were paired and typed with PFGE (Pulse-Field Gel Electrophoresis) method. The strains were then tested for the presence of adherence genes and biofilm formation. RESULTS: The strains with identical PFGE profiles in comparison to those with non-identical profiles differed in terms of the pattern of the virulence genes and showed a lack of the genes related to adherence, but more often presence of IS256, which is related to virulence. They also were phenotypically unable to adhere to intestinal Caco2 cells. CONCLUSIONS: A considerable proportion of CoNS strains isolated from bloodstream of VLBW/LWB neonates was identical to the strains isolated from faeces of the same neonates at the same time. These observations may offer indirect evidence indicating that at least some CoNS can translocate from the gastrointestinal tract of the premature neonates into the bloodstream and thus cause generalized infection.
ABSTRACT
The term neonatal sepsis is used to describe a generalized bloodstream infection of bacterial, viral, or fungal origin which is associated with hemodynamic changes and other clinical symptoms and signs, however, there is no unified definition. There are no basic criteria regarding differentiation of early-onset sepsis (EOS) versus late-onset sepsis (LOS). Stratification used in studies on neonatal sepsis also rarely includes the general condition of the newborn according to unambiguous assessment at birth, which hampers the establishment of a clear, uniform epidemiological description of neonatal sepsis. We aim to review the published data about the epidemiology and microbiology of sepsis in Organization for Economic Cooperation and Development (OECD) countries. Data was also collected on sepsis prevention programs that can be implemented in neonatal units. The outcomes of interest were incidence or incidence density of EOS and LOS, microbiology of EOS and LOS, and data on the methodology of the research, in particular the criteria for inclusion and exclusion of newborns from the study. Pubmed, EMBASE, LILACS Embase, Scopus, and Google Scholar were used. For the preselection step, inclusion criteria included: "bloodstream infection" or "neonatal sepsis" (MesH), "very low birth weight", and "country" full-text studies, human, and English language. Exclusion criteria included: studies published in languages other than English and studies available only as an abstracts. For proper selection, inclusion criteria included: information about epidemiology or microbiology bloodstream infection (BSI), study population and case definitions, exclusion criteria, narrative reviews, commentaries, case studies, pilot studies, study protocols, pediatric studies, and only clinical data (without microbiology or epidemiology) or studies with only one etiological factor analysis. The data review indicated the lack of an unequivocal, unified definition and no unambiguous basic criteria with regard to differentiation of EOS versus LOS. Among infants <1500 g, studies reported an EOS rate from 7% to 2%. For studies using other definitions (mostly all inborn babies), the rate of EOS ranged from 1% to 3%. The LOS incidences were much more varied among countries; the highest rates were in the multicenter studies focused on very low birth weight (VLBW) infants. The main pathogens in EOS are GBS and Gram-negative bacteria in LOS. Our review data shows that LOS microbiology is very diverse and that Gram-positive cocci, especially staphylococci, predominate versus Gram-negative rods. Unfortunately, the lack of uniform, international prevention programs results in high newborn morbidity and insufficient postnatal prevention of late-onset infections.
ABSTRACT
BACKGROUND: Preterm neonates can develop chronic pulmonary insufficiency of prematurity (CPIP) later in infancy. Recombinant human CC10 protein (rhCC10) is an anti-inflammatory agent that could potentially prevent CPIP. METHODS: The safety and efficacy of a single intratracheal dose of rhCC10 in reducing CPIP at 12 months corrected gestational age (CGA) was evaluated in a Phase II double-blind, randomized, placebo-controlled, multisite clinical trial. Eighty-eight neonates were randomized: 22 to placebo and 22 to 1.5 mg/kg rhCC10 in the first cohort and 21 to placebo and 23 to 5 mg/kg rhCC10 in the second cohort. Neonates were followed to 12 months CGA. RESULTS: With CPIP defined as signs/symptoms, medical visits, hospital readmissions, and use of medications for respiratory complications at 12 months CGA, no significant differences were observed between rhCC10 or placebo groups. Only 5% of neonates had no evidence of CPIP at 12 months CGA. CONCLUSIONS: A single dose of rhCC10 was not effective in reducing CPIP at 12 CGA. Since most neonates had evidence of CPIP using these exploratory endpoints, it is essential to develop more robust outcome measures for clinical trials of respiratory medications in high-risk premature neonates.
Subject(s)
Lung Diseases/drug therapy , Respiratory Distress Syndrome, Newborn/drug therapy , Uteroglobin/therapeutic use , Anti-Inflammatory Agents/therapeutic use , Chronic Disease , Double-Blind Method , Female , Genetic Predisposition to Disease , Gestational Age , Humans , Infant, Newborn , Infant, Premature , Infant, Premature, Diseases , Lung/drug effects , Male , Patient Readmission , Patient Safety , Pulmonary Surfactants/administration & dosage , Recombinant Proteins/therapeutic use , Respiration , Risk Factors , Treatment OutcomeABSTRACT
AIM: Probiotic bacteria administered directly after birth to preterm neonates may improve gastrointestinal function and may reduce the incidence of late-onset sepsis, which is a frequent complication in this group. PURPOSE: The main objective of this study was to evaluate whether a new probiotic bacterial mixture of Lactobacillus rhamnosus KL53A and Bifidobacterium breve PB04 given to preterm, low-birth-weight neonates would influence composition of their gut microbiota and sepsis rates. PATIENTS AND METHODS: This study was a multicenter, randomized, double-blind, placebo-controlled trial conducted in clinical centers of neonatal care in Poland. A probiotic or placebo preparation was given twice daily to 181 preterm low-birth-weight neonates who were eligible for enteral feeding between July 2012 and July 2013. The probiotic was given to 90 neonates, while placebo was given to 91 neonates. The gut microbiota was monitored by microbiological analysis of stool samples. Sepsis episodes were detected on the basis of clinical and laboratory findings and confirmed by blood cultures. RESULTS: Tested probiotic administration resulted in continuous increase of the Lactobacillus and Bifidobacterium counts in the gut microbiota. The applied tested strains successfully colonized the neonates gut since they were present in over 90% of stool samples, which was confirmed by molecular analysis. Regardless of the study group (probiotic or placebo), B. breve colonization correlated with lower staphylococcal sepsis incidence, which was irrespective of whether probiotics were given. No sepsis case caused by strains included in study probiotic was recorded. CONCLUSION: Appropriately selected and characterized probiotic bacteria may be safely given to preterm neonates to normalize their distorted gut microbiota and may contribute to lower staphylococcal sepsis rates.
Subject(s)
Fatty Acids, Omega-3 , Premature Birth , Docosahexaenoic Acids , Female , Humans , Infant, Newborn , PregnancyABSTRACT
INTRODUCTION: the aim of this case report is to present that oral L-citrulline supplementation may attenuate chronic pulmonary hypertension and reduce oxygen requirement in infants with severe bronchopulmonary dysplasia. IMPORTANT CLINICAL FINDINGS: a boy, with a birth weight of 700 g, born by cesarean section after 25 weeks of pregnancy complicated with preeclampsia, was admitted to the neonatal intensive care unit. He was ventilatory dependent for the next 3 months with significantly increased oxygen requirements. A severe stage of bronchopulmonary dysplasia, complicated with increased pulmonary vascular resistance, was diagnosed. Treatment with inhaled nitric oxide and oral sildenafil was included in the therapy of chronic pulmonary hypertension. The results of screening echocardiograms and increased plasma brain natriuretic peptide concentrations, suggested right ventricle dysfunction. THE MAIN INTERVENTION: at the beginning of the sixth month of hospitalization, oral supplementation of L-citrulline in a single dose of 150 mg/kg/day was introduced and continued for 70 days. During the first 3 weeks after L-citrulline was started, the patient was weaned from mechanical ventilation and he was never intubated again until he was discharged. Plasma brain natriuretic peptide concentrations decreased significantly during the first month of L-citrulline administration and became stable until the termination of L-citrulline supplementation. At discharge, the patient required 22%-25% concentration of oxygen supplemented intermittently, exclusively during feeding. CONCLUSION: these results indicate that L-citrulline supplementation may deserve coverage as an additional, potentially beneficial alternative in the prophylaxis or therapy of chronic pulmonary hypertension in newborns.
Subject(s)
Ampicillin/administration & dosage , Anti-Bacterial Agents/administration & dosage , Neonatal Sepsis/drug therapy , Pentoxifylline/administration & dosage , Administration, Intravenous , Drug Therapy, Combination , Female , Humans , Infant, Newborn , Infant, Premature , Male , Retrospective StudiesABSTRACT
OBJECTIVE: Background: Respiratory syncytial virus infection causes respiratory diseases in about 90% of the children under 2 years of age. Currently the only way to prevent infection is through immunoprophylaxis based on palivizumab. Aim: The aim of the study was to assess compliance with the recommended prophylaxis regimen in children qualified for the Polish National Programme for Respiratory Syncytial Virus Immunoprophylaxis over six consecutive virus seasons (2008-2014). PATIENTS AND METHODS: Material and methods: A retrospective analysis of data obtained from a multicentre, non-interventional observational study was performed. The prevention programme included 3,780 children aged 4 weeks to 2 years. The analysis included: the course of the neonatal period, clinical features at the time of inclusion in the programme, the immunisation course, and adherence to the palivizumab dosing schedule. RESULTS: Results: During the programme, the children received an average of 3.8 (range 1-5) injections. The highest mean number of injections was recorded in the 2013/14 season (4.3±1), and the lowest in the 2009/10 season (2.7±0.8). Overall, 3,084 children (81.7%) received all of the expected doses, while 2,352 (62.2%) children received injections within the appropriate interdose interval. The probability of non-compliance was higher for males. None of the other demographic, social, or clinical factors seemed to impact compliance. CONCLUSION: Conclusions: Compliance with the monthly dosing schedule of palivizumab is key to achieving the proper immunoprophylaxis efficacy. Education regarding the consequences of non-compliance with the regime and increased doctor-parent communication is recommended in future.
Subject(s)
Antiviral Agents/standards , Antiviral Agents/therapeutic use , Drug Administration Schedule , Guideline Adherence , Palivizumab/therapeutic use , Respiratory Syncytial Virus Infections/drug therapy , Child, Preschool , Female , Humans , Infant , Infant, Newborn , Male , Poland , Retrospective StudiesABSTRACT
BACKGROUND: There is growing evidence that supports the benefits of early use of caffeine in preterm neonates with RDS; however, no formal recommendations specifying the exact timing of therapy initiation have been provided. OBJECTIVES: We compared neonatal outcomes in infants receiving early (initial dose on the 1st day of life) and late (initial dose on day 2+ of life) caffeine therapy. METHODS: Using data from a prospective, cohort study, we identified 986 infants ≤32 weeks' gestation with RDS and assessed the timing of caffeine therapy initiation, need for ventilatory support, mortality and incidence of typical complications of prematurity. To adjust for baseline severity, the early and late caffeine groups were propensity score (PS) matched to 286 infants (1:1). Clinical outcomes were compared between the PS-matched groups. RESULTS: Early treatment with caffeine citrate was associated with a significantly reduced need for invasive ventilation (71.3% vs 83.2%; P = 0.0165) and total duration of mechanical ventilation (mean 5 ± 11.1 days vs 10.8 ± 14.6 days; P = 0.0000) and significantly lower odds of intraventricular hemorrhage (IVH) (OR 0.4827; 95% CI 0.2999-0.7787) and patent ductus arteriosus (PDA) (OR 0.5686; 95% CI 0.3395-0.9523). The incidence of bronchopulmonary dysplasia (BPD) (36.4% vs 45.8%) and rates of moderate and severe BPD were not significantly different between the two groups. The mortality rates were comparable between the two groups (8.6% vs 8.5%, P = ns). CONCLUSION: Early caffeine initiation was associated with a decreased need for invasive ventilatory support and lower incidence of IVH and PDA.
Subject(s)
Caffeine/administration & dosage , Infant, Premature , Respiratory Distress Syndrome, Newborn/drug therapy , Bronchopulmonary Dysplasia/drug therapy , Caffeine/therapeutic use , Humans , Infant, Newborn , Prospective StudiesABSTRACT
AIM: To evaluate compliance and health outcomes in children receiving palivizumab prophylaxis and to identify factors that could impact parental compliance with the recommended regimen of palivizumab immunoprophylaxis. MATERIAL AND METHODS: A retrospective, multicentre, non-interventional study of children enrolled in the Polish National Programme for Respiratory Syncytial Virus (RSV) Immunoprophylaxis who received ≥1 dose of palivizumab during two consecutive RSV seasons (I: 2008-2009, II: 2009-2010). For each child qualified to receive palivizumab, the following data were collected: sociodemographic factors, clinical characteristics at enrolment, and in the course of palivizumab prophylaxis. RESULTS: One thousand twenty-one infants were enrolled into the Registry at 29 sites across Poland and received a total of 3,241 palivizumab injections (average: 3.2 doses per child). The incidence of adverse reactions was 3.33%; nervousness was the most frequently reported event (1.23%). Overall, 771 (75.5%) children received all of their expected injections, whereas 635 (62.2%) children received their injections within the appropriate interdose interval. Compliance was lower in male infants. None of the other demographic, social, or clinical factors seemed to impact compliance. Non-compliant children had a higher rate of hospitalisation due to respiratory illness (22% vs 9.9%, p<0.0001, and 18.4% vs 9.5%, p<0.0001, for compliance defined by the number of expected injections received and by the interdose interval, respectively). CONCLUSIONS: Palivizumab prophylaxis was conducted in accordance with recommendations and was well tolerated in at-risk infants. Non-compliance was higher among male infants and was related with a higher rate of hospitalisation due to respiratory illness.
Subject(s)
Antiviral Agents/administration & dosage , Medication Adherence/statistics & numerical data , Palivizumab/administration & dosage , Patient Compliance/statistics & numerical data , Respiratory Syncytial Virus Infections/prevention & control , Dose-Response Relationship, Drug , Drug Administration Schedule , Female , Guideline Adherence , Humans , Infant, Newborn , Male , Patient Acceptance of Health Care , Poland , Primary Prevention/methodsABSTRACT
Lactoferrin is an iron-binding glycoprotein, which is present in most biological fluids with particularly high levels in colostrum and in mammalian milk. Bovine lactoferrin is more than 70% homologous with human lactoferrin. Most of the clinical trials have used bovine lactoferrin for supplementation. This review summarizes the recent advances in explaining the mechanisms, which are responsible for the multifunctional roles of lactoferrin, and presents its potential prophylactic and therapeutic applications. On the ground of the results of preliminary clinical observations, authors suggest beneficial effect of lactoferrin supplementation on the prevalence of necrotizing enterocolitis in infants with birth weight below 1250 grams.
Subject(s)
Enterocolitis, Necrotizing/prevention & control , Infant, Premature, Diseases/prevention & control , Infant, Very Low Birth Weight , Lactoferrin/administration & dosage , Probiotics/administration & dosage , Female , Humans , Infant, Newborn , Infant, Premature , Male , Sepsis/prevention & controlABSTRACT
BACKGROUND: Previously, we found that plasma protein C (PC) activity ≤10% significantly increased the probability of the occurrence of death during neonatal sepsis. Accordingly, if the activity of plasma PC declined during the course of sepsis to ≤10%, we administered a nonactivated PC zymogen to increase a PC activity. The aim of that retrospective analysis was to explore treatment effects of PC zymogen supplementation in septic infants, with plasma PC activity ≤10%. METHODS: A database was used to locate 85 newborns treated with PC from among 458 analyzed infants with confirmed sepsis. RESULTS: The median birth weight and gestational age of treated infants were, respectively, 1010.0 g and 29 weeks. In 47 infants, early-onset sepsis developed, whereas in 38 neonates, late-onset sepsis was recognized. PC was given as a single dose of 200 IU/kg. Among 458 septic patients, death occurred in 19 newborns (4.2%), exclusively in infants with plasma PC activity ≤10%. In 15 infants, death occurred in the course of early-onset sepsis and 4 newborns died of late-onset sepsis (early-onset sepsis vs. late-onset sepsis; P = 0.036; χ with the Yates correction). CONCLUSIONS: An increased risk of death in septic neonates with plasma PC activity ≤10% suggests the necessity for its evaluation and possibility of supplementation of PC zymogen.