Determination of appropriate dosing of influenza drugs in pediatric patients

Dose-finding studies of influenza antiviral drugs are challenging because it is difficult to enroll subjects in pediatric interventional studies and also because of the lack of concentration (or toxicity)–response relationships, the short duration of antiviral therapy, and the continually developing metabolic profiles of infants and young children. The evaluation of influenza antiviral agents in premature infants adds even more complexity. Recent advances in exposure-targeted study designs and modeling and simulations have aided in addressing some of these challenges.     

Travel-related health and safety considerations for children

Paediatrics is an integral part of travel medicine. More children are travelling overseas to increasingly remote destinations. All practitioners who come into contact with infants and children, whether in designated travel clinics or general practice settings, need to be aware of travel-related concerns. This article addresses the importance of travel-related health and safety for children and the provision of appropriate advice to parents and guardians.     

Conducting psychosocial research with children and adolescents: a developmental perspective.

In the past 10 years, childhood has become a focal point of concern. Children are viewed as symbolizing an investment in the future of societies around the world. In the past, knowledge about children's views was realized through objective measures or from representative accounts by adults (e.g., parents and teachers) who were thought to know the child best. Current research suggests that most adult representations and interpretations are only attempts to describe something that more or less represents the child's world. The literature suggests that in the past, children have been perceived mainly as objects rather than subjects of research interest. This perhaps reflects the viewpoint held by many that children are unable to comprehend and describe their world and life experiences because of developmental immaturity and/or that there are intrinsic difficulties in researching children. The purpose of this article is to describe how a child's developmental level affects the research process. Specifically discussed are developmental differences in responses to research including psychosocial research methods, assent, and consent with children.     

Influence of maturation and growth on cefetamet pivoxil pharmacokinetics: rational dosing for infants.

The pharmacokinetics of intravenous (i.v.) cefetamet and the bioavailability of oral cefetamet pivoxil in infants aged 3.5 to 17.3 months who were hospitalized for urological surgery were characterized. The absorption of cefetamet pivoxil administered in a syrup formulation was 38 +/- 19% (n = 5) for infants, which was comparable to values observed for children and adults. The plasma half-life of i.v. cefetamet was 3.03 +/- 0.96 h (mean +/- standard deviation; n = 20) in the infants. This was not different from the value observed for normal adult subjects but was longer than that reported for children aged 3 to 12 years. Urinary recovery of cefetamet after i.v. administration to infants was 63.4 +/- 17.7% (n = 16), which was less than the 80% recovery found in older children and adults. The steady-state volume of distribution was 399 +/- 116 ml/kg of body weight. It was comparable in size and showed the same dependence on body weight as it did in children and adults. The mean systemic clearance per kilogram of body weight in the infants was lower than that in children and adults, apparently because of immaturity of clearance processes. A model that accounted for maturation and growth with increasing age was developed for the clearance. On the basis of this model, the clearance capacity increased from birth to 5 years by a factor of 4.5 because of maturation. Maturation progressed exponentially, with a half-life of 14 months. This model was used to develop dosing regimen guidelines for pediatric patients aged 3.5 months and older.     

Issues in Pediatric Research: Safeguarding the Children

purpose . To address the ethical question: “How can one safeguard children who participate in research?” patient population . Infants through adolescents. conclusions . Federal guidelines that delineate when research is allowable with children may not be enough to ensure children's safety from harm. practice implications . Risk evaluation conducted by those who understand child development because such understanding allows one to better anticipate children's potential exposure to harm. Safeguarding children requires a conscientious effort to envision children's understanding of events, their potential reactions, and the possible immediate and long-term consequences. This understanding provides the foundation for implementing sound research procedures to safeguard the children.     

Fasten their seatbelts: legal restraint of children in car seats and road ambulances

Registered nurses transport sick children in ambulances and other road vehicles every day in the United Kingdom (U.K.). Safely restraining the child, the equipment and the accompanying adults is a matter which should be addressed by all departments who transport children. A motor vehicle collision may cause an unrestrained child to be seriously injured. An unrestrained child is likely to inflict serious injury on the accompanying nurse or parent. Recent changes in child seat law require that appropriate measures must be put in place to ensure sick children receive the safest possible care. The use of a Regulation 44 compliant child-seat or an appropriately sized five-point stretcher harness should be the default standard when transporting a child in a road vehicle under any circumstances. Recent research also indicates that young infants must never be allowed to sleep in car seats on the ward because of the increased risk of obstructive sleep apnoea.     

Shaken baby syndrome

Unfortunately, head trauma caused by shaken baby syndrome is a common occurrence in infants and young children. The proper treatment and safety of these children can be enhanced by the nurse's ability to recognize features characteristic of this syndrome. If abuse is suspected, appropriate physicians, child-protective, and law-enforcement agencies should be notified immediately. Further research must be done to improve the understanding of the mechanisms associated with this disorder in the ultimate hope of improving the lives and outcome of infants and children.     

Predictive validity of the test of infant motor performance as measured by the Bruininks-Oseretsky test of motor proficiency at school age

BACKGROUND AND PURPOSE: As the survival rate of infants who are born prematurely increases, the need for accuracy in early identification and prediction of developmental outcome in these infants is imperative. This study examined the predictive validity of the Test of Infant Motor Performance (TIMP) and the relationship between perinatal risk and motor performance in children who are of school age. SUBJECTS AND METHODS: A stratified, random sample of 35 children was selected from subjects who had been examined using the TIMP and the Problem-Oriented Perinatal Risk Assessment System (POPRAS). The subjects were between 32 weeks gestational age and 4 months postterm (mean age=10 days postterm). The stratification was based on age at the time of TIMP administration (AGE) and on POPRAS scores. The Bruininks-Oseretsky Test of Motor Proficiency (BOTMP) was administered to the children at a mean age of 5.75 years. Predictive values were calculated and correlation and regression analyses were conducted to examine the relationship between the TIMP and POPRAS scores and the BOTMP score. RESULTS: Using the receiver operating characteristic curve and a cutoff z score of -1.6, the TIMP's sensitivity, specificity, and positive and negative predictive values were.50, 1.00, 1.00, and.87, respectively. The correlation between TIMP and BOTMP scores, with AGE controlled, was.36, and the correlation between POPRAS and BOTMP scores was -.55. Thirty-seven percent of BOTMP variance was accounted for collectively by POPRAS scores, TIMP scores, and AGE. DISCUSSION AND CONCLUSION: The TIMP and POPRAS may be viable instruments that can be used together to identify infants who are at risk for poor long-term motor performance.     

Respiratory syncytial virus (RSV): overview, treatment, and prevention strategies

Respiratory syncytial virus (RSV) is one of the most common diseases of childhood. Virtually all children have been exposed to this virus by age two. RSV causes common cold symptoms in most patients. In vulnerable children, RSV can progress to bronchiolitis and/or pneumonia with an increased chance of significant morbidity or death. The nature of the virus and mode of infection protects it from the human immune system. Treatment for RSV is largely supportive. Key elements of treatment are maintenance of hydration, and oxygenation, as well as keeping the airways clear of mucus. Prevention of RSV in vulnerable infants is important because of the increased morbidity and mortality. A modest effort spent identifying vulnerable infants, educating the parents about RSV and its prevention, and providing immunoprophylaxis to those who qualify for it, increases the chances that these vulnerable children get through the first several years of life without RSV bronchiolitis.     

A role for immune complexes in enhanced respiratory syncytial virus disease

Respiratory syncytial virus (RSV) is the leading cause of bronchiolitis and viral pneumonia in infants and young children. Administration of a formalin inactivated vaccine against RSV to children in the 1960s resulted in increased morbidity and mortality in vaccine recipients who subsequently contracted RSV. This incident precluded development of subunit RSV vaccines for infants for over 30 years, because the mechanism of illness was never clarified. An RSV vaccine for infants is still not available. Here, we demonstrate that enhanced RSV disease is mediated by immune complexes and abrogated in complement component C3 and B cell-deficient mice but not in controls. Further, we show correlation with the enhanced disease observed in children by providing evidence of complement activation in postmortem lung sections from children with enhanced RSV disease.     

Maternal cigarette smoking, breast-feeding, and respiratory tract infections in infancy. A matched-pairs study

The importance of mothers' smoking habits for the occurrence of respiratory tract infections (RTIs) in their children during their infant years was studied. A group of 28 infants of mothers who smoked was compared with 28 infants of non-smokers. The pairs were matched with respect to mother's age, marital status, occupation, and parity. During their first year of life, the smokers' children were treated with antibiotics because of RTIs more often than the non-smokers' children (p = 0.046). The number of RTIs in the two groups were 38 and 19, respectively. However, infants of mothers who smoked were breast-fed for a shorter period than those of non-smokers (p = 0.028), the mean values being 4.5 and 6.7 months.     

A comparison of the efficacy of weight-shift vs. joystick control of a robotic mobility device by infants ages 5 to 10 months

The onset of crawling in infants contributes to cognitive, perceptual, social, and emotional development. Conversely, infants with motor impairment that delays or prevents autonomous mobility often have associated developmental delays. Evidence suggests that providing mobility may have positive developmental outcomes, however powered wheelchairs may not be recommended for very young children, due to safety concerns and the child’s level of cognitive maturity. The WeeBot is a mobility device controlled by infant weight shifting while seated; infants as young as 5 months have learned to use it. This study compares the efficacy of using the WeeBot vs. using the traditional manual joystick to control a robotic mobility device. Participants were 20 typically developing infants between 5 and 10 months who had not yet achieved independent mobility. A quasi-experimental two-group design was used: The first 10 participants recruited used the WeeBot (weight-shift); the next 10 used the joystick. Results showed that infants learned to use weight-shift control more easily and more skilfully than did infants using the joystick. The ability of infants to use the WeeBot suggests that an intuitive alternative control might allow very early powered mobility for children with disabilities, which might have implications for various aspects of their development.     

Ethics Seminars: Vulnerable Populations in Emergency Medicine Research

Regulatory bodies and institutional review boards are increasingly considering human subjects who are vulnerable to research not because of their intrinsic characteristics, but because of the particular situations or circumstances that they bring with them as potential research participants. Several subsets of emergency department patients may be considered vulnerable in the research setting. This may include patients who are vulnerable because of a medical condition, a baseline limitation of intellectual function, a social setting, psychosocial stressors, or other factors. These issues should be carefully considered when including such patients in research protocols. Special efforts should be made to ensure voluntary participation and understanding of the purposes and risks of participation.     

Child safety seat counseling: three keys to safety

The number one cause of death for children younger than 14 years is vehicular injury. Child safety seats and automobile safety belts protect children in a crash if they are used correctly, but if a child does not fit in the restraint correctly, it can lead to injury. A child safety seat should be used until the child correctly fits into an adult seat belt. It is important for physicians caring for children to know what child safety seats are available and which types of seats are safest. Three memory keys will help guide appropriate child safety seat choice: (1) Backwards is Best; (2) 20-40-80; and (3) Boost Until Big Enough. "Backwards is Best" cues the physician that infants are safest in a head-on crash when they are facing backward. "20-40-80" reminds the physician that children may need to transition to a different seat when they reach 20, 40, or 80 lb. "Boost Until Big Enough" emphasizes that children need to use booster seats until they are big enough to fit properly into an adult safety belt.     

Maternal and fetal outcomes if gestational impaired glucose tolerance is not treated

OBJECTIVE: To evaluate whether there is increased maternal or neonatal morbidity in connection with impaired glucose tolerance (IGT) during pregnancy when the condition is not treated. RESEARCH DESIGN AND METHODS: During the study period of 1997-2001, in a defined geographical area in Sweden, the diagnostic criteria for gestational diabetes mellitus (GDM) were limited to the criteria for diabetes. Prospectively, 213 women who were identified with IGT during pregnancy were undiagnosed and untreated. Data on maternal and fetal outcome was collected from records. For each case subject, four control subjects were taken from the same delivery department. RESULTS: The proportion of women who underwent cesarean section was significantly higher in the case subjects than in the control subjects and was independently associated with IGT. The adjusted odds ratio (OR) was 1.9 (95% CI 1.2-2.9). The proportion of infants who were large for gestational age (LGA), defined as birth weight >2 SDs greater than the mean for gestation and sex, was independently significantly associated with untreated IGT during pregnancy (OR 7.3, 95% CI 4.1-12.7). Admission to a neonatal intensive care unit (NICU) for 2 days or longer was more common (adjusted OR 2.0, 95% CI 1.1-3.8). However, 71.3% of the children in the IGT group and 87.3% of the control subjects had no neonatal complications. CONCLUSIONS: There is increased independent association between cesarean section rate, prematurity, LGA, and macrosomic infants born to mothers with untreated IGT. Most of the children were healthy, but there is still increased morbidity. Therefore, to evaluate the effects of treatment, there is a need for a randomized study.     

Car seat challenges: where are we in implementation of these programs?

Premature infants and infants with special needs are being discharged home at smaller weights and earlier postconceptional ages. This presents a challenge to safely transporting these infants in car seats. Car seat technology has not kept abreast of advances experienced in neonatal medical technology. Several studies have demonstrated that preterm infants are at risk for apnea, bradycardia, and oxygen desaturations while being transported in traditional car seats. The American Academy of Pediatrics issued policy statements recommending that all infants less than 37 weeks of gestational age be monitored in a car seat safety test prior to discharge. This article reviews current literature on implementing car seat safety testing in hospitals and the results of a research survey of newborn nursery and neonatal intensive care units across the United States to evaluate the status of these facilities in implementing car seat safety testing programs. The results show that many level II and level III units have begun to implement car seat safety programs despite the lack of literature and guidelines available on how to develop a program. Although most programs monitored the same criteria, there were variations in length of testing, which infants were tested, and recommendations for the infants who failed the testing.     

The Effects of Handling on Preterm Infants with Bronchopulmonary Dysplasia

Bronchopulmonary dysplasia (BPD) is a commonplace problem of infants who are bom with a birth weight under 1,500 grams and who require mechanical ventilation. The immature nervous system of these infants is easily overwhelmed by sensory overload in the intensive care nursery. The purpose of this research was to: (a) quantify the physiologic distress signals (PDS) exhibited by the infant with BPD during handling procedures and (b) compare these findings to a group of healthy preterm infants from birth through hospital discharge. The subjects were 32 preterm infants, 9 of whom had BPD. From 28 to 38 weeks postconceptual age the infants with BPD demonstrated significantly more tachycardia, tachypnea and bradycardia when being handled as well as other subtle physiologic distress signals. They were significantly older when selected PDS disappeared. These findings have implications for planning care for infants with BPD.     

Unlicensed and off-label uses of drugs in paediatrics: a review of the literature

The off-label and unlicensed use of drugs to treat children is a common practice that occurs either in hospital or in the community. This derives from the fact that research for establishing drug efficacy and safety in children has not been carried out due to ethical problems, logistical difficulties, financial and legal concerns. In this work we report the studies available in literature documenting the extent of drug use in the paediatric field outside the recommendations of the license. From our analysis, a widespread attitude to prescribe medicines to children outside their product license either in the hospitals or in the community is confirmed. This suggests an immediate action for a more rationale use of drugs in paediatrics, to avoid exposing children and infants to unnecessary risks, but also to avoid depriving them of potentially effective and sometimes life-saving therapies.     

Safety features of budesonide inhalation suspension in the long-term treatment of asthma in young children

Early inhaled corticosteroid treatment improves symptom control and pulmonary function in children with asthma; however, long-term safety data are limited in infants and young children. This study assessed the long-term safety of budesonide inhalation suspension (BIS) in young children with persistent asthma. To continue to provide BIS to children who needed it—prior to US Food and Drug Administration approval—children 8 years of age or younger with mild, moderate, or severe persistent asthma who previously completed a 52-week open-label study of BIS were enrolled in an additional multicenter, open-label study that was to be concluded upon BIS approval. Patients already receiving BIS continued their current regimens. Patients younger than 4 years and those 4 years of age or older not receiving BIS at baseline started with total daily doses of 0.5 and 1.0 mg, respectively. BIS doses were adjusted throughout the study based on individual response. Adverse events and changes in laboratory parameters, vital signs, and physical examination findings were assessed. Of 198 enrolled patients, 152 (76.8%), 68 (34.3%), and 31 (15.7%) completed 1, 2, and 3 years of BIS treatment (mean daily dose 0.62±0.32 mg), respectively. One hundred sixty-six (83.8%) patients experienced an adverse event, of which 8.6% were considered by the investigator to be drug related. Adverse events were those typically occurring in a pediatric asthma population, with respiratory infection (49.0%) and sinusitis (25.3%) occurring at the greatest incidence. Only 2 patients withdrew due to adverse events. Mean changes in laboratory test results and physical examination findings were not clinically important throughout the study. Long-term BIS treatment is well tolerated in young children with persistent asthma, with a safety profile similar to that of short-term administration.     

电子胃肠镜检查在婴儿消化道出血诊治中的意义研究

目的:对电子肠胃镜检查在婴儿消化道出血诊治中的意义进行研究,为电子肠胃镜在婴幼儿消化道诊治中的应用提供理论基础与实践依据。材料与方法:将我院2013年6月~2013年12月接诊的68例消化道出血患儿作为研究对象,使用电子胃肠镜对患儿进行检查,观察并记录明确诊断例数,并通过问卷调查的形式了解患儿家属的满意度。结果:68例患儿中,明确诊断64例,诊断率94.1%;并发症情况:2例患儿粘膜受损,1例切除息肉后残蒂渗血;68例患儿家属总满意度为93.9%。结论:使用电子肠胃镜对消化道出血患儿进行检查,安全性能良好,诊断率高,能有效改善患儿生存质量,提高家长满意度,为疾病的诊治提供重要参考信息,适合于临床推广应用。