Abstract: Whilst the prevalence of low blood pressure in preterm infants seems to have fallen over the last number of years, the problem is still frequently encountered in the neonatal intensive care unit and many babies continue to receive intervention. Great variability in practice persists, with a significant number of extremely low gestational age newborns in some institutions receiving some form of intervention, and in other units substantially less. A great degree of this variability relates to the actual criteria used to define hypotension, with some using blood pressure values alone to direct therapy and others using a combination of clinical, biochemical and echocardiography findings. The choice of intervention remains unresolved with the majority of centres continuing to administer volume followed by dopamine as a first line inotrope/vasopressor agent. Despite over 40 years of use there is little evidence that dopamine is of benefit both in the short term and long-term. Long-term follow up is available in only two randomised trials, which included a total of 99 babies. An under recognized problem relates to the administration of inotrope infusions in very preterm infants. There are no pediatric specific inotrope formulations available and so risks of errors in preparation and administration remain. This manuscript outlines these challenges and proposes some potential solutions.
Abstract: The objective of this paper was to review existing information regarding food effects on drug absorption within paediatric populations. Mechanisms that underpin food–drug interactions were examined to consider potential differences between adult and paediatric populations, to provide insights into how this may alter the pharmacokinetic profile in a child. Relevant literature was searched to retrieve information on food–drug interaction studies undertaken on: (i) paediatric oral drug formulations; and (ii) within paediatric populations. The applicability of existing methodology to predict food effects in adult populations was evaluated with respect to paediatric populations where clinical data was available. Several differences in physiology, anatomy and the composition of food consumed within a paediatric population are likely to lead to food–drug interactions that cannot be predicted based on adult studies. Existing methods to predict food effects cannot be directly extrapolated to allow predictions within paediatric populations. Development of systematic methods and guidelines is needed to address the general lack of information on examining food–drug interactions within paediatric populations.
Abstract: The present study investigated the current state of unnecessary children food allergy accommodation and the medical efforts to confirm the existence of food allergies in school lunch service kitchens in Okinawa, Japan, including kitchens accommodating food allergy students by requiring medical documentation at the start and during provisions being made (Double Diagnosis), requiring medical documentation at the start only (Single Diagnosis), and with no medical documentation (Non-Diagnosis). Unnecessary accommodations are being made to unconfirmed food allergy students, wherein the more medical consultation was required, the lower the food allergy incident rate was and the more food allergens were diagnosed (Non-Diagnosis > Single Diagnosis > Double Diagnosis). This study suggests the possibility that unconfirmed food allergy students may be receiving unnecessary food allergy accommodations per school lunches, and the number of unnecessary food allergy provisions being made could be reduced by requiring medical documentation at the start and during these provisions.
Abstract: This article aims to provide an insight into play as an important aspect of children’s lives in an under-studied area of Iran. Our observations focus on the province of Kohgilouyeh and Boyer Ahmad with its ancient nomadic cultures. Through first-hand knowledge and lived experiences, supplemented by available literature, we seek to look at children’s games in the frame of culture change, exploring their relationship with children’s health and wellbeing. Play, as in every region in the world, conveys and reflects the dominant culture and teaches the values of the society in which the children live in the here and now and in which they will have to function as adults. Yet, types of play are not static. They develop alongside social, political and economic changes and embrace new forms emerging from modern lifestyles. The latter sometimes come into conflict with and challenge the local culture and traditional types of play, which are based on the lives and histories of the indigenous peoples and local communities. A sample of traditional tribal forms of play is analyzed for their health, entertainment and fun aspects. Such play allows children to prepare for life’s realities, in particular for a life of cooperation. By contrast, whilst also providing children with tools and skills for the needs of modern life, new types of play focus more on competition and individualism. This divergence expressed in different types of play widens the generation gap and contributes to alienation. The shift from a collective to individualistic lifestyle thus has an unsettling impact on the community and impacts on the emotional and physical wellbeing of children. We will describe types of play and their role in the holistic development of nomadic children, as well as the impact of modernization and social change, including sedentarization. The article will highlight some consequences of the demise of indigenous play, through observation and analytical comparison of children’s play in three generations. Based on the insights gained, the authors offer recommendations on how to restore traditional play and games through redesigning them to be capable of adaptation to changes in lifestyles.
Abstract: Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA)’s Pediatric Committee (PDCO) may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs)/ethics committees (ECs) and that clinical trials resulting from negotiations with EMA’s PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients.
Abstract: The development of drug products for pediatric use often requires age-appropriate formulations which can be more complex and may involve a broader range of excipients than adult dosage forms. Excipients established for adult use are not always appropriate for use in children because they can affect children differently than adults. Therefore, a comprehensive safety assessment of the excipients in a pediatric formulation is essential before use, referring to existing safety data from adult human and animals as well as safety data from pediatric use and juvenile toxicity studies, when available. The overall risk assessment needs to consider the safety risk from the excipients and the extent to which the risk from the disease as such will be ameliorated by the drug formulation. Non-clinical safety studies in juvenile animals are used to assess for specific toxicities or sensitivities of excipients and for establishing safe exposures in pediatric age groups. As for any active ingredient, non-clinical safety studies in juvenile animals should only be performed for excipients if important for clinical risk assessment and labelling. Pharmaceutical companies should be critical of excessive demands for juvenile animal testing, particularly of excipients when critically needed for significant therapeutic benefit.