Safety In Young Children Research Articles

Long-term effect of everolimus on epilepsy and growth in children under 3 years of age treated for subependymal giant cell astrocytoma associated with tuberous sclerosis complex

BackgroundTuberous sclerosis complex (TSC) is a genetic disorder characterized by increased mammalian target of rapamycin (mTOR) activation and growth of benign tumors in several organs throughout the body. In young children with TSC, drug-resistant epilepsy and subependymal giant cell astrocytomas (SEGAs) present the most common causes of mortality and morbidity. There are also some reports on the antiepileptic and antiepileptogenic potential of mTOR inhibitors in TSC. However, the data on everolimus efficacy and safety in young children are very limited. AimsTo show the long-term safety data and the effect of everolimus treatment on epilepsy in children under the age of 3 who received everolimus for SEGAs associated with TSC. MethodsWe present the results of everolimus treatment in 8 children under the age of 3 who participated in EXIST-1 study. Five patients presented with active, drug-resistant epilepsy at baseline. The mean follow-up is 35 months (33–38 months) and all children are still on treatment. ResultsIn 6 out of 8 children, at least a 50% reduction in SEGA volume was observed. In 1 child with drug-resistant epilepsy, everolimus treatment resulted in cessation of seizures and in 2 other children, at least a 50% reduction in the number of seizures was noted. The incidence of adverse events (AE) was similar to that observed in older children and adults. ConclusionsThis study suggests that everolimus is effective and safe in infants and young children with epilepsy and SEGA associated with TSC and offers a valuable treatment option.

AAAAI Membership Experience with Allergen Immunotherapy (AIT) Safety in Young Children and Pregnant Women

AAAAI Membership Experience with Allergen Immunotherapy (AIT) Safety in Young Children and Pregnant Women

Supervision of Children in Agricultural Settings: Implications for Injury Risk and Prevention

ABSTRACT Farm environments pose unique safety hazards for children. With this in mind, this paper raises several points about how caregiver supervision influences risk of childhood injuries. First, research suggests that it is not the absence of a supervisor per se but the poorer quality of supervision that leads to pediatric injuries on farms, particularly for young children who behave in unpredictable ways at a time when caregivers are likely to be distracted with farm work. Second, research suggests that “adequate” supervision varies with context. In nonfarm contexts, continuous attention and close proximity (i.e., being within arm's reach) constitute an adequate level of supervision to ensure young children's safety. In agricultural contexts, attention and continuity are also relevant. However, close proximity is less beneficial because this often results in exposing children to hazards (animals, dangerous equipment) if the supervisor is working. Third, research suggests that in both agricultural and nonagricultural contexts, the extent to which supervision is associated with injury varies with a child's developmental level. Specifically, supervision seems to play a more primary role in moderating injury risk for young children (preschool), and this influence decreases as children age and increasingly independent are allowed to engage in more activities without a supervisor present. Building on these findings, practical recommendations are provided to enhance the safety of children on farms and future research directions are discussed.

Cough in the Pediatric Population

Cough is the most common presenting symptom for medical office visits in the United States. Cough in children is usually related to viral respiratory tract infection and typically resolves spontaneously. Between 35% and 40% of school-age children still cough 10 days after the onset of a common cold, and 10% of preschool children have cough 25 days after respiratory tract infection. 1 Hay A.D. Wilson A. Fahey T. Peters T.J. The duration of acute cough in preschool children presenting to primary care: a prospective cohort study. Fam Pract. 2003; 20: 696-705 Crossref PubMed Scopus (121) Google Scholar In children, cough has been associated with environmental factors, such as outdoor and indoor air pollution, including particulate matter, irritant gases, environmental tobacco smoke exposure, and dampness in the home. 2 Fuentes-Leonarte V. Tenias J.M. Ballester F. Levels of pollutants in indoor air and respiratory health in preschool children: a systematic review. Pediatr Pulmonol. 2009; 44: 231-233 Crossref PubMed Scopus (44) Google Scholar The frequent presentation of cough in children is further complicated by studies documenting that parental reporting of cough in children correlates poorly with objective measurement of frequency, duration, or intensity of cough. 3 Archer L.N.J. Simpson H. Night cough counts and diary cough scores in asthma. Arch Dis Child. 1985; 60: 473-474 Crossref PubMed Scopus (92) Google Scholar Cough in children disrupts both the parent's and the child's daily activities and can be associated with impaired quality of life in the child and significant stress in parents that improves with cough resolution. 4 Marchant J.M. Newcombe P.A. Juniper E.F. Sheffield J.K. Stathis S.L. Chang A.B. What is the burden of chronic cough for families?. Chest. 2008; 134: 303-309 Crossref PubMed Scopus (150) Google Scholar It is extremely common for parents to treat children with over-the-counter (OTC) cough and cold medications (CCMs) before seeing a health care provider. In a recent survey, approximately 10% of US children were found to be receiving an OTC CCM in any given week. Although OTC CCMs receive Food and Drug Administration (FDA) approval for adults, testing for efficacy and safety in young children has not been adequate, 5 Lokker N. Sanders L. Perrin E.M. Kumar D. Finkle J. Franco V. et al. Parental misinterpretations of over-the-counter pediatric cough and cold medication labels. Pediatrics. 2009; 123: 1464-1471 Crossref PubMed Scopus (106) Google Scholar and inappropriate use of CCMs in children has been documented. 6 Schaefer M.K. Shehab N. Cohen A.L. Budnitz D.S. Adverse events from cough and cold medications in children. Pediatrics. 2008; 121: 783-787 Crossref PubMed Scopus (86) Google Scholar Adverse events associated with use of OTC CCMs do occur and rare infant deaths have been reported. In January 2008, the FDA issued a public health advisory regarding OTC CCM use in children questioning safety and efficacy and whether the clinical benefits justify potential risks; 7 US Food and Drug Administration Nonprescription Drug Advisory Committee. Cold, cough, allergy, bronchodilator, antiasthmatic drug products for over-the-counter human use, October 18 and 19, 2007. Available from: www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4323b1-02-FDA.pdf. Accessed September 21, 2008. Google Scholar it now recommends avoiding these medications in children under age 2 years. The FDA also has supported the recent recommendation by the Consumer Health Product Association to avoid OTC CCM use in children under age 4 years. An American Academy of Pediatrics (AAP) position statement questions the efficacy and safety of these medications in children under age 6 years.

Well-being and outdoor pedagogies in primary schooling: The nexus of well-being and safety

Society today is inundated by a multitude of messages regarding the risks and dangers that affect youngsters, with media constantly talking about ‘cotton wool’ kids (see Furedi, 1997, 2001, 2006) and an ‘obesity epidemic’ (see Wright and Harwood, 2009). A social panic has been created by the media, which ignores the positive outcomes of risk-taking, sensationalises risks, and focuses on the dangers of the world. In popular discourse contradictions are in evidence, on the one hand adults are concerned about the safety of young children; on the other hand many argue that society wraps children in ‘cotton wool’ such that they are denied opportunities to play outdoors for fear of accidents. Research has shown that negotiating risks and relating them to individual capacities is essential for the development of young children and their ability to learn from their mistakes and become aware of their personal health and safety (Fenech, Sumsion, & Goodfellow, 2006). This paper is based on a pilot study that explores young children and their significant others’ perceptions and experiences of risk and safety, looking particularly at the ways in which experiences of outdoor learning may affect the well-being of children. Using an ethnographic approach the research examines how parents and teachers define well-being, and how being in the outdoors is seen to affect pupils’ well-being. This paper, a work in progress, asks if and how outdoor activities, through outdoor learning, contribute to the physical and emotional well-being of young children, briefly touching on theories of power and control.

A Proposal of a Smart Home Service Based on Context-Awareness - with Emphasis on Young Children's Safety -

A Proposal of a Smart Home Service Based on Context-Awareness - with Emphasis on Young Children's Safety -

Postnatal Depression and Infant Health Practices Among High-Risk Women

Women’s postnatal depressive symptoms have been associated with many adverse outcomes for children. The current study examined the frequency association with relative risk between postnatal depressive symptoms and mothers’ use of preventative infant health practices. The study used the Edinburgh Postnatal Depression Scale (EPDS) and Parental Health and Depression Questionnaire (PHDQ) to identify women’s depressive symptoms in a prospective longitudinal sample of 134 high-risk non-white mothers receiving well-baby health services. Unadjusted frequency comparisons examined the effect of women’s postnatal depressive symptoms on infant outcomes. Results found that compared to 60 women without postnatal depressive symptoms, 74 women with symptoms engaged in significantly fewer well-child health-visits, were less likely to use home safety devices or place their infants in the preferred back-to-sleep position, and did not complete immunizations. Depressed women were also more likely to lack knowledge of nurturing and sensitive parenting, use corporal punishment and inappropriate foods, and to show poor parenting practices. These findings provide additional supportive evidence that more efforts are needed to identify and assess women’s depressive symptoms to promote health and safety of young children. Methodological limitations and recommendations for future research are addressed.

Safety of Trivalent Inactivated Influenza Vaccine in Children 6 to 23 Months Old

Beginning with the winter season of 2004-2005, influenza vaccination has been recommended for all children 6 to 23 months old in the United States. However, its safety in young children has not been adequately studied in large populations. To screen for medically attended events in the clinic, emergency department, or hospital after administration of trivalent inactivated influenza vaccine in children 6 to 23 months old. Retrospective cohort using self-control analysis, with chart review of significant medically attended events at 8 managed care organizations in the United States that comprise the Vaccine Safety Datalink. Participants were all children in the Vaccine Safety Datalink cohort 6 to 23 months old who received trivalent inactivated influenza vaccine between January 1, 1991, and May 31, 2003 (45,356 children with 69,359 vaccinations). Any medically attended event significantly associated with trivalent inactivated influenza vaccine in risk windows 0 to 3 days, 1 to 14 days (primary analysis), 1 to 42 days, or 15 to 42 days after vaccination, compared with 2 control periods, one before vaccination and the second after the risk window. All individual ICD-9 codes as well as predefined aggregate codes were examined. Before chart review, only 1 diagnosis, gastritis/duodenitis, was more likely to occur in the 14 days after trivalent inactivated influenza vaccine (matched odds ratio [OR], 5.50; 95% confidence interval [CI], 1.22-24.81 for control period 1, and matched OR, 4.33; 95% CI, 1.23-15.21 for control period 2). Thirteen medically attended events were less likely to occur after trivalent inactivated influenza vaccine, including acute upper respiratory tract infection, asthma, bronchiolitis, and otitis media. After chart review, gastritis/duodenitis was not significantly associated with trivalent inactivated influenza vaccine (matched OR, 4.00; 95% CI, 0.85-18.84 for control period 1; matched OR, 3.34; 95% CI, 0.92-12.11 for control period 2). In the largest population-based study to date of the safety of trivalent inactivated influenza vaccine in young children, there were very few medically attended events, none of which were serious, significantly associated with the vaccine. This study provides additional evidence supporting the safety of universally immunizing all children 6 to 23 months old with influenza vaccine.

A Probabilistic Arsenic Exposure Assessment for Children Who Contact CCA‐Treated Playsets and Decks, Part 1: Model Methodology, Variability Results, and Model Evaluation

Concerns have been raised regarding the safety of young children who may contact arsenic residues while playing on and around chromated copper arsenate (CCA)-treated wood playsets and decks. Although CCA registrants voluntarily canceled the production of treated wood for residential use in 2003, the potential for exposure from existing structures and surrounding soil still poses concerns. The EPA's Office of Research and Development developed and applied the probabilistic Stochastic Human Exposure and Dose Simulation model for wood preservatives (SHEDS-Wood) to estimate children's absorbed dose of arsenic from CCA. Skin contact with, and nondietary ingestion of, arsenic in soil and wood residues were considered for the population of children in the United States who frequently contact CCA-treated wood playsets and decks. Model analyses were conducted to assess the range in population estimates and the impact of potential mitigation strategies such as the use of sealants and hand washing after play events. The results show predicted central values for lifetime annual average daily dose values for arsenic ranging from 10(-6) to 10(-5) mg/kg/day, with predicted 95th percentiles on the order of 10(-5) mg/kg/day. There were several orders of magnitude between lower and upper percentiles. Residue ingestion via hand-to-mouth contact was determined to be the most significant exposure route for most scenarios. Results of several alternative scenarios were similar to baseline results, except for the scenario with greatly reduced residue concentrations through hypothetical wood sealant applications; in this scenario, exposures were lower, and the soil ingestion route dominated. SHEDS-Wood estimates are typically consistent with, or within the range of, other CCA exposure models.

Don't run with scissors: young children's knowledge of home safety rules.

To examine 4- to 6-year-old children's knowledge of their parents' home safety rules and to identify predictors of children's home injuries. Within the context of an interview, parents completed a home safety questionnaire in which they specified home safety rules, rated their child's compliance with each rule, explained not having rules, reported on maternal supervision, and reported on the frequency of their child's injuries. We evaluated children's knowledge of home safety rules by having them play a home safety game designed for this study. Children spontaneously recalled only about half of their parents' home safety rules. Prompting resulted in their recognition of about 40% more rules. However, children's knowledge scores did not predict the frequency of their injuries. The best predictors of children's injuries were children's compliance with home safety rules and extent of parental supervision. These findings suggest that interventions to promote young children's safety knowledge will not likely reduce childhood injuries unless children consistently comply with these rules or parents supervise children to ensure compliance.

Epidemiology in early childhood education

Early childhood educators are keen observers of young children, and as such are important sources of information about the health and safety of young children. This paper discusses the importance to quality early childhood programs of an epidemiological approach to those observations. Surveillance is described using examples from the literature on preschoolers’ unintentional injuries. Basic epidemiological measurements (count, rate, incidence, prevalence) as well as the constructs of descriptive epidemiological studies (e.g., prospective, retrospective) are also presented using examples from early childhood health and safety studies. A five step plan to conduct an epidemiological study (define the problem, literature review, protocol, data collection, data analysis) is outlined. The importance of teachers providing first‐hand documentation of health, safety and development of young children is stressed.

Acetaminophen Poisoning in Infancy

Acetaminophen is widely used in children of all ages, and overdosage from this medication is common. Although severe hepatotoxicity from over-dosage occurs in adults, acetaminophen seems to have a wide margin of safety in younger children. This has been ascribed to altered pharmacokinetics in this age group. We report two cases in which severe acetaminophen-induced hepatoxocity occurred in two infants. Neither infant reportedly received potentially toxic dosages, by history, but toxic drug levels were present in both.